[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shockwave Medical, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":111},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,42,64,92],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100567001","forward-cad-ide-study-100567001",false,"NCT06662500","FORWARD CAD IDE Study","Prospective, Multicenter, Single-Arm, Investigational Device Exemption (IDE) Study of the Shockwave Intravascular Lithotripsy (IVL) System With the Shockwave Javelin Coronary IVL Catheter (FORWARD CAD IDE Study)","General Inclusion Criteria:\n\n1. Subject is ≥18 years of age\n2. Subject is able and willing to comply with all assessments in the study.\n3. Subjects with native coronary artery disease including stable angina or following stabilization after acute coronary syndromes (ACS) for non-emergent percutaneous coronary intervention (PCI)\n4. Biomarkers (troponin) must be:\n\n   1. less than or equal to the upper limit of lab normal within 24 hours prior to the procedure or may be drawn from the side port of the sheath at the time of index if the PCI is a non-emergent procedure and has stable angina (result will not be known prior to procedure); OR\n   2. if above the upper limit of lab normal, biomarker result must be less than 5 times the upper limit of lab normal within 24 hours prior to the procedure and the following criteria must be met: • The procedure must not be emergent and the subject cannot have angina at rest.\n5. Left ventricular ejection fraction (LVEF) \\>30% within 6 months (note: in the case of an event (MI or Revascularization) the LVEF must be taken post-event and in the case of multiple assessments of LVEF, the measurement closest to enrollment will be used for this criterion; may be assessed at time of index procedure).\n6. Subject, or legally authorized representative, signs a written Informed Consent form to participate in the study, prior to any study-mandated procedures.\n7. Estimated life expectancy \\>1 year.\n8. Lesions in non-target vessels requiring PCI may be treated either:\n\n   1. \\>30 days prior to the study procedure if the procedure was unsuccessful or complicated; OR\n   2. \\>24 hours prior to the study procedure if the procedure was successful and uncomplicated (defined as a final lesion angiographic diameter stenosis \\\u003C30% and TIMI 3 flow (visually assessed) for all non-target lesions and vessels without perforation, cardiac arrest or need for defibrillation or cardioversion or hypotension\u002Fheart failure requiring mechanical or intravenous hemodynamic support or intubation, and no evidence of elevated biomarkers post-procedure; OR\n   3. \\>30 days after the study procedure\n\n   Angiographic Inclusion Criteria\n9. The target lesion must be a de novo coronary lesion that has not been previously treated successfully with any interventional procedure\n10. Single de novo target lesion stenosis of protected LMCA, or LAD, RCA or LCX (or of their branches)\n11. The target vessel reference diameter must be ≥2.5 mm and ≤4.0 mm\n12. The target lesion must meet one of the following criteria:\n\n    1. Target lesion stenosis \\>90% up to 40 mm in length and evidence of moderate or severe calcification at the lesion site. Moderate calcification defined as angiography with densities noted only during the cardiac cycle prior to contrast injection; severe calcification defined as angiography with fluoroscopic radio-opacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall; OR\n    2. Chronic total occlusion presenting with J-CTO score of 1 with evidence of calcification and occlusion length up to 20 mm.\n13. Guidewire must be in true lumen, distal to the lesion, and not subintimal, prior to insertion of Shockwave Javelin Coronary IVL catheter (antegrade wire technique only)\n\nGeneral Exclusion Criteria:\n\n1. Any comorbidity or condition which may prevent compliance with this protocol, including follow-up visits\n2. Subject is participating in another research study involving an investigational agent including pharmaceutical, biologic, or medical device that has not reached the primary endpoint\n3. Subject is pregnant or nursing (a negative pregnancy test is required for women of child-bearing potential within 7 days prior to enrollment)\n4. Unable to tolerate antiplatelet\u002Fanticoagulation therapy per society guidelines\n5. Subject has an allergy to imaging contrast media which cannot be adequately pre-medicated\n6. Subject experienced an acute STEMI within 30 days prior to index procedure\n7. New York Heart Association (NYHA) class III or IV heart failure\n8. Subject has acute or chronic renal disease with eGFR \\\u003C30 ml\u002Fmin\u002F1.73m2 (using institutional formula)\n9. History of a stroke or transient ischemic attack (TIA) within 60 days, or any prior intracranial hemorrhage or permanent neurologic deficit\n10. Active peptic ulcer or upper gastrointestinal (GI) bleeding within 3 months\n11. Untreated pre-procedural hemoglobin \\\u003C10 g\u002FdL or intention to refuse blood transfusions if one should become necessary\n12. Coagulopathy, including but not limited to platelet count \\\u003C100,000 or International Normalized ratio (INR) \\>1.7 (INR is only required in subjects who have taken warfarin within 2 weeks of enrollment)\n13. Subject has a hypercoagulable disorder such as polycythemia vera, platelet count \\>750,000 or other disorders\n14. Subject has an active systemic infection on the day of the index procedure with either fever, leukocytosis or requiring intravenous antibiotics\n15. Subjects with clinical evidence of cardiogenic shock\n16. Uncontrolled severe hypertension (systolic BP \\>180 mm Hg or diastolic BP \\>110 mm Hg)\n17. Subjects with an estimated life expectancy of less than 1 year\n18. Non-coronary interventional or surgical structural heart procedures (e.g., TAVR, MitraClip, LAA or PFO occlusion, etc.) within 30 days prior to the index procedure\n19. Planned non-coronary interventional or surgical structural heart procedures (e.g., TAVR, MitraClip, LAA or PFO occlusion, etc.) within 30 days after the index procedure\n20. Subject refusing or not a candidate for emergency coronary artery bypass grafting (CABG) surgery\n21. Planned use of atherectomy, scoring or cutting balloon, sub-intimal reentry device, or any investigational device other than coronary IVL\n\n    Angiographic Exclusion Criteria\n22. Unprotected left main diameter stenosis \\>30%\n23. Evidence of a serious angiographic complication in the target vessel prior to treatment with coronary IVL (dissection, perforation, abrupt closure, persistent slow-flow or persistent no reflow)\n24. Definite or possible thrombus by angiography in the target vessel\n25. Evidence of aneurysm in target vessel within 10 mm of the target lesion\n26. Second lesion with \\>50% stenosis in the same target vessel as the target lesion including its side branches\n27. Chronic total occlusion of the target lesion, J-CTO ≥2\n28. Target lesion is located in a native vessel that can only be reached by going through a saphenous vein or arterial bypass graft\n29. Previous stent within 5 mm of the target lesion\n30. Failure to successfully cross the guidewire across the target lesion\n31. Planned use of antegrade dissection and reentry (ADR), retrograde guidewire (RW), or retrograde dissection and reentry (RDR) crossing technique at any time during the procedure.","ALL","18 Years",{"count":19,"type":20},408,"ESTIMATED","INTERVENTIONAL",[23],"NA","The FORWARD CAD IDE Study is a Prospective, Multicenter, Single-Arm, Investigational Device Exemption (IDE) Study conducted to assess the safety and effectiveness of the Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Coronary IVL Catheter for the treatment of calcified, stenotic de novo coronary artery lesions prior to stenting.",[26],"Coronary Arterial Disease (CAD)",[28],"Intravascular Lithotripsy","RECRUITING","2026-06-01",{"date":32,"type":33},"2026-06-03","ACTUAL",{"date":35,"type":33},"2025-04-04",{"date":37,"type":20},"2027-12",{"name":39,"class":40},"Shockwave Medical, Inc.","INDUSTRY",34,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":63},"100447098","efficacy-of-the-coronary-sinus-reducer-in-patients-with-refractory-angina-ii-100447098","NCT05102019","Efficacy of the COronary SInus Reducer in Patients With Refractory Angina II","COSIRA-II","Inclusion Criteria:\n\n1. Subject is older than 18 years of age\n2. Symptomatic coronary artery disease (CAD) with greater than or equal to 90 days of persistent refractory angina pectoris classified as CCS Grade III or IV despite maximally tolerated guideline directed medical therapy as determined by the local heart team and confirmed by a Central Screening Eligibility Committee Note: subjects may also have exertional dyspnea, but the symptoms that limit activity must be anginal in nature (including chest pain, pressure, heaviness, discomfort, with or without radiation to the neck, jaw, shoulders, arms, or other location) and not dyspnea\n3. Must have attempted treatment with the maximally tolerated dose of at least three of the four (preferably all four) approved classes of anti-anginal agents: long-acting nitrates, calcium channel blockers (either a dihydropyridine or a non-dihydropyridine), beta blockers, and ranolazine. The regimen must be stable for at least 30 days prior to enrollment, must remain stable from enrollment to randomization, and there must be no intent to change the medical regimen for at least 12 months after randomization Note: If the dose of a medication was increased or decreased for a temporary period and then returned to the original dose, which will then be continued for at least 12 months after randomization, the subject may be immediately enrolled without needing to otherwise requalify\n4. Subject has either no treatment options for revascularization by coronary artery bypass grafting or by percutaneous coronary intervention, or is otherwise unsuitable or high risk for revascularization as determined by the local heart team, and confirmed by a Central Screening Eligibility Committee\n5. Evidence of either exercise or pharmacologically induced reversible ischemia severity by stress echo, nuclear study, PET, perfusion MRI, CT perfusion, FFR-CT, FFR, iFR, or other non-hyperemic FDA approved tests (such as diastolic hyperaemia free ratio \\[DRF\\] or resting full-cycle ratio \\[RFR\\] in the distribution of the left coronary artery (LCA), performed within 12 months prior to enrollment Note: If the subject has evidence of ischemia in both the LCA and RCA distributions, the extent of ischemia must be greater in the LCA distribution Note: The qualifying assessment must be performed after any myocardial infarction, CABG, or successful PCI within the prior 12 months. For subjects with multiple assessments, the one performed closest to enrollment will serve as the qualifying study\n6. Functional limitation due to refractory angina as defined by a modified Bruce exercise tolerance test duration of greater than or equal to 2 minutes but less than or equal to 10 minutes, performed while the subject is maintained on their stable regimen of maximally tolerated doses of anti-anginal medications Note: The ETT variability must be less than 20% between last two ETTs performed.\n7. Left ventricular ejection fraction (LVEF) greater than or equal to 30% within the 12-months prior to enrollment Note: The LVEF must be reassessed after any intervening myocardial infarction. For subjects with multiple assessments, the most recent LVEF assessment is used as the qualifying test.\n8. Subject is willing and able to sign informed consent\n9. Subject is willing to comply with the specified follow-up evaluations\n\nAngiographic Inclusion Criteria:\n\n1\\) Three-vessel coronary angiography performed within 12 months prior to enrollment demonstrating obstructive CAD (visually estimated diameter stenosis of ≥70% or ≥50% - \\\u003C70% with fractional flow reserve (FFR) value of ≤0.80 or an iFR or other FDA-approved\u002Fcleared non-hyperemic physiological assessment (such as DFR or RFR) of ≤0.89 in one or more lesions) in the left coronary artery (main epicardial vessels or branches) that is not suitable for and will not be treated with PCI or CABG as determined by the local heart team Note: The qualifying 3-vessel angiogram must be performed after any myocardial infarction, PCI, or CABG within the 12 months prior to enrollment. For patients with multiple 3-vessel angiograms, the one performed closest to enrollment will serve as the qualifying study\n\nExclusion Criteria:\n\n1. Recent (within 30 days prior to enrollment) troponin or CKMB positive acute coronary syndrome (NSTEMI or STEMI) Note: subjects with an elevated troponin or CKMB without acute coronary syndrome may still be enrolled\n2. Recent successful revascularization by either CABG or PCI within six months prior to enrollment\n\n   Note: Successful revascularization is defined as any CABG procedure, or any PCI procedure with a reduction of one or more lesions to \\\u003C50% diameter stenosis\n\n   Note: Subjects with successful revascularization by either CABG or PCI that occurred less than six months prior to enrollment may still be approved for participation in the trial if revascularization was completed six months prior to procedure and CSEC approves subject participation\n3. Recent unsuccessful PCI (e.g., failed attempt to open a chronic total occlusion) within 30 days prior to enrollment\n\n   Note: Subjects with unsuccessful PCI that occurred less than 30 days prior to enrollment may still be approved for participation in the trial if PCI was completed 30 days prior to procedure and CSEC approves subject participation\n4. The predominant manifestation of angina is dyspnea\n\n   Note: some dyspnea may be present with exertion, but the predominant symptom that limits activity must be angina (i.e., chest pain, pressure, tightness, heaviness, or discomfort, with or without radiation to the neck, jaw, shoulders, arms, or other location)\n5. Has extra-coronary contributory causes of angina - e.g., untreated hyperthyroidism, untreated anemia (hgb \\\u003C10 g\u002FdL), uncontrolled hypertension (systolic blood pressure \\>160 mmHg or diastolic blood pressure \\>100 mmHg despite medications), atrial fibrillation with rapid ventricular response (consistently \\>100 bpm despite medications) or other tachyarrhythmia, severe aortic stenosis, hypertrophic cardiomyopathy with left ventricular outflow tract obstruction or asymmetric septal hypertrophy (concentric left ventricular hypertrophy is not an exclusion criterion), or epicardial vasospasm disease\u002Fcoronary artery vasospasm (CAS)\u002Fvasospastic angina (VSA)\n6. NYHA Class III or IV heart failure (HF), decompensated HF or hospitalization due to HF during the 90 days prior to enrollment\n7. Life threatening rhythm disorders or any rhythm disorders that would require future placement of an internal defibrillator and\u002For pacemaker\n8. Severe chronic obstructive pulmonary disease (COPD) as indicated by a forced expiratory volume in one second (FEV1) that is less than 55% of the predicted value, or need for home daytime oxygen or oral steroids\n9. Severe valvular heart disease (any valve)\n10. Moderate or severe RV dysfunction by echocardiography\n11. Pacemaker electrode\u002Flead is present in the coronary sinus\n12. A Class I indication is present for an implantable defibrillator or cardiac resynchronization therapy according to ACCF\u002FAHA\u002FHRS guidelines\n13. Recent implantation of a new pacemaker or defibrillator lead with electrode in the right atrium within 90 days of enrollment\n14. Chronic severe renal failure (estimated eGFR less than 30 mL\u002Fmin\u002F1.73m2 by the MDRD formula) or subjects on chronic dialysis\n15. Known allergy to stainless steel or nickel\n16. Any clinical condition that might interfere with the trial protocol or the subject's ability to be compliant with the trial protocol (e.g., active alcohol or drug abuse, dementia, magnetic resonances imaging (MRI) planned within 8 weeks of procedure)\n17. Currently enrolled in another investigational device or drug trial that has not reached its primary endpoint or that might clinically interfere with the current trial endpoints or procedures\n18. Pregnant or planning pregnancy within the next 12 months (women of reproductive potential must have a negative pregnancy test within 7 days of the procedure)\n19. Subject is part of a vulnerable population who, in the judgment of the investigator, is unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include individuals with mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention.\n20. Inability to tolerate dual antiplatelet therapy for 6 months if not on a chronic oral anticoagulant, or inability to tolerate a P2Y12 inhibitor for at least 6 months if on a chronic oral anticoagulant\n21. Comorbidities limiting life expectancy to less than one year\n22. Subject is currently hospitalized for definite or suspected COVID-19\n23. Subject has previously been symptomatic with or hospitalized for COVID-19 and has been asymptomatic for \\\u003C8 weeks prior to enrollment or has not returned to his or her prior baseline (pre-COVID-19) clinical condition\n24. Subject is asymptomatic but has had a positive PCR or antigen test for COVID-19 within the past 4 weeks prior to enrollment\n\nAngiographic\u002FHemodynamic Exclusion Criteria:\n\n1\\) Coronary anatomy amenable to revascularization of ischemic myocardial territory by either PCI or CABG with at least moderate likelihood of long-term alleviation of angina or angina equivalent symptoms, as per the assessment of the local heart team.\n\nNote: If a pathway to coronary revascularization is present which, in the opinion of the local heart team, is reasonably low risk and reasonably likely to provide long-term symptom relief and the subject refuses the revascularization procedure, the patient is ineligible for randomization\n\nProcedural Angiographic\u002FHemodynamic Randomization Exclusion Criteria:\n\n1. Mean right atrial pressure greater than 15 mmHg assessed during the final screening procedure for eligibility assessment and potential randomization\n2. Anomalous or abnormal CS anatomy (e.g., tortuosity, aberrant branch, persistent left superior vena cava \\[SVC\\]) as demonstrated by angiogram\n3. The CS diameter at the most proximal end of the planned implant region (2-4 cm distal to the coronary sinus ostium) is less than 9.5 mm or greater than 13.0 mm\n\nSingle-arm Registry (Unblinded, Non-Randomized Treatment Arm) Inclusion\u002FExclusion Criteria:\n\nSubject can be included in the single-arm registry if they fall into one of the three categories with inclusions and exclusion criteria as described below.\n\nPredominant right coronary disease subjects (RCA):\n\n1. Reversible ischemia: Subjects with evidence of either exercise or pharmacologically induced reversible ischemia by stress echo, nuclear study, PET, perfusion MRI, CT perfusion, FFR-CT, FFR, iFR, or other non-hyperemic FDA approved or cleared tests (such as DFR or RFR) in the distribution of the right coronary artery (RCA), performed within 12 months prior to enrollment.\n\n   Note: If the subject has evidence of ischemia in both the LCA and RCA distributions, the extent of ischemia must be greater in the RCA distribution\n\n   Note: The qualifying assessment must be performed after any myocardial infarction, CABG, or successful PCI within the prior 12 months. If the anti-anginal medication regimen is permanently changed after the assessment of ischemia, the test must be repeated. For subjects with multiple assessments, the one performed closest to enrollment will serve as the qualifying study\n2. Obstructive CAD: Three-vessel coronary angiography performed within the 12 months prior to enrollment demonstrating obstructive CAD (visually assessed diameter stenosis of ≥70% or ≥50% - \\\u003C70% with fractional flow reserve (FFR) value of ≤0.80 or an iFR or other FDA-approved\u002Fcleared non-hyperemic physiological assessment (such as DFR or RFR) of ≤0.89 in one or more lesions) in the RCA (main epicardial vessels or branches) that is not suitable for and will not be treated with PCI or CABG as determined by the local heart team.\n\n   Note: The qualifying assessment must be performed after any myocardial infarction, PCI or CABG within the prior 12 months. For subjects with multiple assessments, the one performed closest to enrollment will serve as the qualifying study\n3. In addition to the above inclusion criteria, subjects must meet all inclusion criteria (except clinical inclusion #5 and angiographic inclusion #1) and none of the exclusion criteria of the main randomized trial\n\nNon-obstructive coronary artery disease subjects (ANOCA)\n\n1. Abnormal Coronary Flow Reserve (CFR): subjects must have either abnormal PET CFR (\\\u003C 2.0), abnormal perfusion CMR (cardiac MRI) CFR (\\\u003C1.85), or abnormal invasive CFR (\\\u003C2.5) in at least one main epicardial coronary artery performed within 12 months prior to enrollment\n\n   Note: Subjects may or may not have evidence of either exercise or pharmacologically induced reversible ischemia by stress echo, nuclear study, PET, perfusion MRI, or CT perfusion\n2. Non-obstructive CAD: subjects have non-obstructive coronary disease (estimated diameter stenosis in all coronary lesions is \\\u003C50% and (if performed) FFR ≥0.81 or a non-hyperemic test is ≥0.90) demonstrated on three-vessel coronary angiography performed within the 12 months prior to enrollment. If an estimated diameter stenosis is ≥50% to \\\u003C70%, the patient may still qualify if FFR ≥0.81 or a non-hyperemic test is ≥0.90 in that vessel. If both FFR and a non-hyperemic test are performed, both must be negative.\n\n   Note: The qualifying 3-vessel angiogram must be performed after any myocardial infarction, PCI or CABG within the 12 months prior to enrollment. For patients with multiple 3-vessel angiograms, the one performed closest to enrollment will serve as the qualifying study\n3. In addition to the above inclusion criteria, subjects must meet all inclusion criteria (except clinical inclusion #5 and angiographic inclusion #1) and none of the exclusion criteria of the main randomized trial\n\nSubjects unable to complete ETT\n\n1. Subjects must be unable to complete the required COSIRA-II exercise tolerance test due to lower limb amputation (above the ankle) or other physiologic condition with documented chronic mobility or balance issues that require the use of a walking aid (e.g., wheelchair, cane, rollator, crutches, or knee walker).\n2. In addition to the above inclusion criteria, subjects must meet all inclusion criteria (except clinical inclusion #6) and none of the exclusion criteria of the main randomized trial\n\nPrior to inclusion in single-arm registry, all subjects will be reviewed by the Central Screening Eligibility Committee to ensure that they meet registry inclusion criteria and are not eligible for enrollment into the randomized study.",{"count":50,"type":20},380,[23],"To demonstrate the safety and effectiveness of the Shockwave Reducer for treatment of patients with refractory angina pectoris treated with maximally tolerated guideline-directed medical therapy who demonstrate objective evidence of reversible myocardial ischemia in the distribution of the left coronary artery and who are deemed unsuitable for revascularization. A non-randomized single-arm registry will further assess the safety and effectiveness of the Shockwave Reducer in selected subjects with reversible myocardial ischemia in the distribution of the right coronary artery and who are deemed unsuitable for revascularization, subjects without documented obstructive coronary disease and abnormal coronary flow reserve (ANOCA), and subjects who cannot complete an exercise tolerance test due to lower limb amputation (above the ankle) or other physiologic condition with documented chronic mobility or balance issues that require the use of a walking aid.",[54],"Refractory Angina","2026-04-20",{"date":57,"type":33},"2026-04-22",{"date":59,"type":33},"2022-01-04",{"date":61,"type":20},"2032-01",{"name":39,"class":40},95,{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":21,"phases":74,"briefSummary":75,"conditions":76,"keywords":79,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":4},"100632318","study-of-the-shockwave-medical-skyrunner-carotid-intravascular-lithotripsy-ivl-system-for-the-treatment-of-calcified-carotid-arteries-prior-to-trans-femoral-stenting-skyward-trans-femoral-ide-investigational-device-exemption-study-100632318","NCT07512128","Study of the Shockwave Medical SkyRunner Carotid Intravascular Lithotripsy (IVL) System for the Treatment of Calcified Carotid Arteries Prior to Trans-Femoral Stenting (SKYWARD Trans-Femoral IDE [Investigational Device Exemption] Study)","Prospective, Multi-center, Single-arm Study of the Shockwave Medical SkyRunner Carotid Intravascular Lithotripsy (IVL) System for the Treatment of Calcified Carotid Arteries Prior to Trans-Femoral Stenting (SKYWARD Trans-Femoral IDE Study)","SKYWARD TF","General Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Patient is able and willing to comply with all assessments in the study.\n3. Patient has been informed of the nature of the study, agrees to participate and has signed the approved informed consent form.\n4. Patient approved for inclusion by a Patient Screening Committee.\n5. Patient must have a life expectancy \\> 1 year at the time of the index procedure, in the opinion of the investigator at the time of enrollment, with no planned major cardiac intervention or surgery within 30 days following the index procedure.\n\n   Angiographic Inclusion Criteria:\n6. Patient has a discrete lesion located in the internal carotid artery (ICA) with or without involvement of the carotid bifurcation.\n7. Target lesion must meet all requirements for commercially available trans-femoral stent systems (refer to IFU for requirements) and investigator intends to treat the target lesion with a single stent.\n8. Patient must meet one of the following criteria regarding neurological symptom status and degree of stenosis by duplex ultrasound in combination with CT or MR angiography:\n\n   1. Symptomatic: ≥ 50% stenosis of the internal carotid artery and the patient has a history of stroke, TIA and\u002For amaurosis fugax within 180 days of the procedure ipsilateral to the carotid artery to be treated.\n\n      OR\n   2. Asymptomatic: ≥ 70% stenosis of the internal carotid artery without any neurological symptoms.\n9. Patient has evidence of circumferential calcification of the stenotic lesion defined as ≥ 3 mm thickness of calcification as determined by Computed Tomography Angiography (CTA). MR angiography may be used in place of CTA for patients with a relative or absolute contraindication to CTA.\n10. Patient is high risk for CEA defined as meeting at least one anatomic or clinical high-risk condition listed below:\n\nAnatomic High Risk Inclusion Criteria:\n\n* Target lesion at or above C2 (level of jaw) or below the clavicle\n* Inability to extend the head due to cervical arthritis or other cervical disorders\n* History of radiation treatment to the neck or radical neck dissection\n* Prior head and neck surgery in the region of the carotid artery\n* Spinal immobility of the neck\n* Tracheostomy or tracheostoma\n* Hostile neck or surgically inaccessible lesion\n* Laryngeal palsy or laryngectomy\n* Severe tandem lesions (total length must be ≤ 30 mm and must be covered with one stent)\n* Occlusion of the contralateral CCA or ICA\n* Severe bilateral ICA stenosis\n\nClinical High-Risk Inclusion Criteria\n\n* Patient is ≥ 70 years of age.\n* Patient has congestive heart failure (CHF) - New York Heart Association (NYHA) Functional Class III or IV.\n* Patient has severe pulmonary disease (COPD) with either FEV \\\u003C 50% predicted or chronic oxygen therapy or resting PO2 of \\\u003C 60 mmHg (room air).\n* Patient has a history of angina Canadian Cardiovascular Society (CCS) class 3 or 4 or unstable angina.\n* Patient has known severe left ventricular dysfunction LVEF \\\u003C 30%.\n* Patient had a myocardial infarction \\> 72 hours and \\\u003C 6 weeks prior to procedure.\n* Coronary artery disease with two or more vessels with ≥ 70% stenosis.\n* Planned coronary artery bypass grafting (CABG) or valve replacement surgery between 31 and 60 days after index procedure.\n* Patient has permanent contralateral cranial nerve injury\u002Fparalysis.\n* Patient has chronic renal insufficiency (serum creatinine ≥ 2.5 mg\u002FdL). Note that patients on dialysis are excluded from study consideration per exclusionary criterion #13.\n* Planned abdominal aortic aneurysm repair or peripheral vascular surgery between 31 to 60 days after index procedure.\n\nGeneral Exclusion Criteria:\n\n1. Patient has alternative source of cerebral embolus, including but not limited to:\n\n   1. a history of chronic atrial flutter or atrial fibrillation, or paroxysmal atrial flutter or atrial fibrillation requiring chronic anticoagulation\n   2. knowledge of cardiac sources of emboli (e.g. left ventricular aneurysm, intracardiac filling defect, cardiomyopathy, aortic or mitral prosthetic heart valve, hemodynamically significant aortic stenosis, endocarditis, mitral stenosis, or left atrial myxoma)\n   3. recently (\\\u003C 60 days) replaced\u002Frepaired heart valve (either surgically or percutaneously).\n2. Patient has a history of spontaneous intracranial hemorrhage within the past 12 months, a hemorrhagic transformation of an ischemic stroke within the past 60 days or has had a recent stroke (\\\u003C 7 days) of sufficient size (on CT or MRI) to place the patient at risk of hemorrhagic conversion during the procedure.\n3. Patient with a history of major stroke with substantial neurological deficit (NIHSS ≥ 5 or mRS ≥ 3) within 1 month of index procedure.\n4. Patient has had a TIA, or amaurosis fugax within 48 hours prior to the procedure.\n5. Patient has neurologic illnesses within the past 2 years characterized by fleeting or fixed neurologic or cognitive deficit which cannot be distinguished from TIA or stroke.\n6. Patient has an intracranial tumor.\n7. Patient has an unresolved\u002Funcorrected bleeding disorder.\n8. Patient had a myocardial infarction (MI) within last 72 hours prior to index procedure.\n9. Patient has history of intolerance or allergic reaction to contrast material that cannot be adequately premedicated or to any of the required study medications (i.e., antiplatelet agents, statins) or device materials (refer to IFUs).\n10. Female patients who are pregnant, nursing, or may become pregnant.\n11. Patient is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached its primary endpoint.\n12. Patient has other medical, social, or psychological problems that, in the opinion of the investigator, would present difficulty in complying with protocol requirements.\n13. Patient is on renal replacement therapy (i.e., dialysis).\n\n    Angiographic Exclusion Criteria:\n14. Presence of a previously placed intravascular stent in the target vessel or ipsilateral CCA.\n15. A significant CCA inflow or distal\u002Fintracranial lesion.\n16. Occlusion (TICI 0) or \"string sign\" \\> 1 cm of the ipsilateral common or internal carotid artery.\n17. An intraluminal filling defect consistent with thrombus.\n18. Presence of extensive or diffuse atherosclerotic disease involving the aortic arch or proximal common carotid artery that would preclude the safe introduction of the study device.\n19. Cerebral aneurysm, symptomatic or \\> 5 mm or AVM (arteriovenous malformation) of the cerebral vasculature.\n20. Massive exophytic (mushroom-like) or irregular endoluminal calcification seen on CTA or fluoroscopy.\n21. Failure to successfully cross the guidewire across the target lesion; successful crossing defined as tip of the guidewire distal to the target lesion.\n22. Type III or Bovine aortic arch anatomy.\n23. Angulation or tortuosity (≥ 90 degree) of the innominate and common carotid artery (CCA) that precludes safe, expeditious sheath placement or that will transmit a severe loop to the internal carotid after sheath placement.",{"count":73,"type":20},185,[23],"Prospective, Multi-center, Single-arm Study of the Shockwave Medical SkyRunner Carotid Intravascular Lithotripsy (IVL) System for the Treatment of Calcified Carotid Arteries Prior to Trans-Femoral stenting (SKYWARD Trans-Femoral IDE Study)",[77,78],"Carotid Artery Calcification","Carotid Artery Diseases",[80,81,82],"IVL","Calcification","Carotid Calcification","NOT_YET_RECRUITING","2026-03-30",{"date":86,"type":33},"2026-04-06",{"date":88,"type":20},"2026-07",{"date":90,"type":20},"2032-12",{"name":39,"class":40},{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":21,"phases":100,"briefSummary":101,"conditions":102,"keywords":103,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":4},"100597744","study-of-the-shockwave-medical-skyrunner-carotid-intravascular-lithotripsy-ivl-system-for-the-treatment-of-calcified-carotid-arteries-prior-to-trans-carotid-stenting-skyward-trans-carotid-ide-investigational-device-exemption-study-100597744","NCT07062471","Study of the Shockwave Medical SkyRunner Carotid Intravascular Lithotripsy (IVL) System for the Treatment of Calcified Carotid Arteries Prior to Trans-Carotid Stenting (SKYWARD Trans-Carotid IDE [Investigational Device Exemption] Study)","Prospective, Multi-center, Single-arm Study of the Shockwave Medical SkyRunner Carotid Intravascular Lithotripsy (IVL) System for the Treatment of Calcified Carotid Arteries Prior to Trans-Carotid Stenting (SKYWARD Trans-Carotid IDE Study)","General Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Patient is able and willing to comply with all assessments in the study.\n3. Patient has been informed of the nature of the study, agrees to participate and has signed the approved informed consent form.\n4. Patient approved for inclusion by a Patient Screening Committee.\n5. Patient must have a life expectancy \\> 1 year at the time of the index procedure, in the opinion of the investigator at the time of enrollment, with no planned major cardiac intervention or surgery within 30 days following the index procedure.\n\n   Angiographic Inclusion Criteria:\n6. Patient has a discrete lesion located in the internal carotid artery (ICA) with or without involvement of the carotid bifurcation.\n7. Target lesion must meet all requirements for commercially available trans-carotid stent systems (refer to IFU for requirements) and investigator intends to treat the target lesion with a single stent.\n8. Patient must meet one of the following criteria regarding neurological symptom status and degree of stenosis by duplex ultrasound in combination with CT or MR angiography:\n\n   1. Symptomatic: ≥ 50% stenosis of the internal carotid artery and the patient has a history of stroke, TIA and\u002For amaurosis fugax within 180 days of the procedure ipsilateral to the carotid artery to be treated.\n\n      OR\n   2. Asymptomatic: ≥ 70% stenosis of the internal carotid artery without any neurological symptoms.\n9. Patient has evidence of circumferential calcification of the stenotic lesion defined as ≥ 3 mm thickness of calcification as determined by Computed Tomography Angiography (CTA). MR angiography may be used in place of CTA for patients with a relative or absolute contraindication to CTA.\n10. Patient is high risk for CEA defined as meeting at least one anatomic or clinical high-risk condition listed below:\n\nAnatomic High Risk Inclusion Criteria:\n\n* Contralateral Carotid artery occlusion.\n* Tandem Stenoses \\> 70%.\n* High cervical carotid artery stenosis.\n* Restenosis after carotid endarterectomy.\n* Bilateral carotid artery stenosis requiring treatment within 30 days after index treatment.\n* Hostile neck anatomy but which the Investigator deems safe for trans- carotid access including but not limited to:\n\n  * Prior neck irradiation\n  * Radical neck dissection\n  * Cervical spine immobility\n\nClinical High Risk Inclusion Criteria:\n\n* Patient is ≥ 70 years of age.\n* Patient has congestive heart failure (CHF) - New York Heart Association (NYHA) Functional Class III or IV.\n* Patient has severe pulmonary disease (COPD) with either FEV \\\u003C 50% predicted or chronic oxygen therapy or resting PO2 of \\\u003C 60 mmHg (room air).\n* Patient has a history of angina Canadian Cardiovascular Society (CCS) class 3 or 4 or unstable angina.\n* Patient has known severe left ventricular dysfunction LVEF \\\u003C 30%.\n* Patient had a myocardial infarction \\> 72 hours and \\\u003C 6 weeks prior to procedure.\n* Coronary artery disease with two or more vessels with ≥ 70% stenosis.\n* Planned coronary artery bypass grafting (CABG) or valve replacement surgery between 31 and 60 days after index procedure.\n* Patient has permanent contralateral cranial nerve injury\u002Fparalysis.\n* Patient has chronic renal insufficiency (serum creatinine ≥ 2.5 mg\u002FdL). Note that patients on dialysis are excluded from study consideration per exclusionary criterion #16.\n* Planned abdominal aortic aneurysm repair or peripheral vascular surgery between 31 to 60 days after index procedure.\n\nGeneral Exclusion Criteria:\n\n1. Patient has alternative source of cerebral embolus, including but not limited to:\n\n   1. a history of chronic atrial flutter or atrial fibrillation, or paroxysmal atrial flutter or atrial fibrillation requiring chronic anticoagulation\n   2. knowledge of cardiac sources of emboli (e.g., left ventricular aneurysm, intracardiac filling defect, cardiomyopathy, aortic or mitral prosthetic heart valve, hemodynamically significant aortic stenosis, endocarditis, mitral stenosis, or left atrial myxoma)\n   3. recently (\\\u003C 60 days) replaced\u002Frepaired heart valve (either surgically or percutaneously).\n2. Patient has a history of spontaneous intracranial hemorrhage within the past 12 months, a hemorrhagic transformation of an ischemic stroke within the past 60 days or has had a recent stroke (\\\u003C 7 days) of sufficient size (on CT or MRI) to place the patient at risk of hemorrhagic conversion during the procedure.\n3. Patient with a history of major stroke with substantial neurological deficit (NIHSS ≥ 5 or mRS ≥ 3) within 1 month of index procedure.\n4. Patient has had a TIA, or amaurosis fugax within 48 hours prior to the procedure.\n5. Patient has neurologic illnesses within the past 2 years characterized by fleeting or fixed neurologic or cognitive deficit which cannot be distinguished from TIA or stroke.\n6. Patient has an intracranial tumor.\n7. Patient has an isolated hemisphere.\n8. Patient has an open stoma in the neck.\n9. Patient has an unresolved\u002Funcorrected bleeding disorder.\n10. Patient had a myocardial infarction (MI) within last 72 hours prior to index procedure.\n11. Patient has contralateral laryngeal, lateral recurrent, or vagus nerve injury.\n12. Patient has history of intolerance or allergic reaction to contrast material that cannot be adequately premedicated or to any of the required study medications (i.e., antiplatelet agents, statins) or device materials (refer to IFUs).\n13. Female patients who are pregnant, nursing, or may become pregnant.\n14. Patient is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached its primary endpoint.\n15. Patient has other medical, social, or psychological problems that, in the opinion of the investigator, would present difficulty in complying with protocol requirements.\n16. Patient is on renal replacement therapy (i.e., dialysis).\n\n    Angiographic Exclusion Criteria:\n17. Presence of a previously placed intravascular stent in the target vessel or ipsilateral CCA.\n18. A significant CCA inflow or distal\u002Fintracranial lesion.\n19. Occlusion (TICI 0) or \"string sign\" \\> 1 cm of the ipsilateral common or internal carotid artery.\n20. An intraluminal filling defect consistent with thrombus.\n21. CCA disease that would preclude the use of TCAR per IFU.\n22. Presence of extensive or diffuse atherosclerotic disease involving the aortic arch or proximal common carotid artery that would preclude the safe introduction of the study device.\n23. Patient has \\\u003C 5 cm of distance between the clavicle and bifurcation, as assessed by duplex ultrasound.\n24. Cerebral aneurysm, symptomatic or \\> 5 mm or AVM (arteriovenous malformation) of the cerebral vasculature.\n25. Massive exophytic (mushroom-like) or irregular endoluminal calcification seen on CTA or fluoroscopy.\n26. Failure to successfully cross the guidewire across the target lesion; successful crossing defined as tip of the guidewire distal to the target lesion.",{"count":73,"type":20},[23],"Prospective, Multi-center, Single-arm Study of the Shockwave Medical SkyRunner Carotid Intravascular Lithotripsy (IVL) System for the Treatment of Calcified Carotid Arteries prior to Trans-Carotid Stenting (SKYWARD Trans-Carotid IDE Study)",[77,78],[80,82,81],{"date":105,"type":33},"2026-04-03",{"date":107,"type":20},"2026-05",{"date":109,"type":20},"2032-10",{"name":39,"class":40},""]