[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"M.A. Med Alliance S.A.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":76},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"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":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100443507","selution4btk-trial-100443507",false,"NCT05055297","SELUTION4BTK Trial","SELUTION SLR™ 014 BTK: A Prospective Randomized Multicenter Single Blinded Study to Assess the Safety and Effectiveness of the SELUTION SLR™ 014 Drug Eluting Balloon in the Treatment of Below-the-Knee (BTK) Atherosclerotic Disease in Patients With Chronic Limb Threatening Ischemia (CLTI)","Clinical Inclusion Criteria:\n\n1. Subject age is ≥ 18 years or older depending on local regulations.\n2. Subject life expectancy is ≥ 1 year.\n3. Subject has documented chronic limb-threatening ischemia in the target limb with Rutherford classification category 4 or 5 and symptoms of \\> 2 weeks duration.\n4. Subject is willing and able to provide written informed consent and comply with study procedures and required follow-up evaluations.\n5. Female subjects of childbearing potential must be non-breastfeeding and have a negative pregnancy test ≤ 7 days before the procedure.\n\nAngiographic Inclusion Criteria:\n\nSubjects must meet all the following criteria to be enrolled in the trial:\n\n1. Target lesion(s) must be de novo or non-stented restenotic lesion(s) located within the BTK arteries distal to the tibial plateau and above the tibiotalar joint line. BTK arteries include the P3 segment of the popliteal artery, the tibio-peroneal trunk, peroneal artery, anterior tibial artery, and posterior tibial artery.\n2. BTK Target lesions cannot be contiguous with inflow lesions and at least 3 cm of normal artery should extend beyond the tibial plateau to ensure there is no overlap.\n3. Target lesions must have a diameter stenosis of ≥ 70% (including total occlusions) by visual estimate and must be indicated for PTA treatment.\n4. Target vessel reference diameter(s) are ≥ 2mm and ≤ 4mm. Note: the SELUTION SLR 014 DEB and the control PTA balloon size cannot exceed 4.0 mm.\n5. Target lesions must be confined to a single target vessel. NOTE: Subjects with other non-target BTK lesions in separate non-target vessels may be enrolled, provided that the non-target lesions have been successfully treated (residual stenosis ≤ 30% with no distal embolization or flow limiting ≥ Grade C dissection). NOTE: Any adjunctive therapies are permitted for the treatment of non-target BTK lesions, but no DEB or DES may be used.\n6. Any target lesion must be ≥ 30 mm in length and the total combined length of all target lesions must be ≤ 140 mm (total treatment length ≤ 150 mm allowing for 5 mm proximal and distal shoulder treatment). Note: All target lesions and all inflow lesions must be treatable by one or more SELUTION SLR 014\u002F018 DEB(s) such that the total planned per-subject drug dose (calculated by summing the drug dose of all individual planned balloon sizes) would be ≤ 7069 μg. Note: A total treated segment length of ≤ 150 mm for BTK and ≤ 200 mm for inflow segment is acceptable irrespective of DEB balloon diameter.\n7. The tibial and pedal runoff distal to the target lesions must be patent OR the target vessel(s) must reconstitute above the ankle or display normal terminal branching as follows:\n\n   1. If the target vessel is the P3 segment, any 1 of the 3 distal arteries must show a patent (≤ 50% stenosis by visual estimate) outflow.\n   2. If the target vessel is the peroneal artery, the artery must demonstrate normal terminal branching.\n   3. If the target vessel is the anterior tibial (AT) or posterior tibial (PT) artery, the artery must reconstitute ≥ 1 cm above the tibiotalar joint to provide an intact runoff vessel (AT: dorsalis pedis; PT: plantar artery).\n   4. If the target vessel is the tibio-peroneal trunk, outflow for either the peroneal OR the posterior tibial artery must be patent (≤ 50% stenosis by visual estimate).\n8. Subjects is free of significant inflow vessel disease or any inflow disease has been successfully treated (see angiographic inclusion # 9). Significant inflow disease is defined as ≥ 50% stenosis by visual estimate. Inflow vessels include the ipsilateral common iliac, external iliac, common femoral, profunda femoris, superficial femoral or popliteal artery proximal (≥ 3 cm) to the tibial plateau. Note: If access site doesn't permit angiographic imaging of the common iliac and common femoral artery (CFA), then non-invasive imaging (CTA or MRA) must be provided to exclude presence of significant inflow disease. If non-invasive imaging is not possible, a DUS of the CFA with a multiphasic wave form excluding significant disease AND a palpable ipsilateral femoral pulse must be documented.\n9. Subjects with significant inflow disease (≥ 50% stenosis by visual estimate) must have documented successful treatment before randomizing the subject. Successful treatment of inflow disease is defined as ≤ 30% final residual stenosis and no distal embolization or flow-limiting \\> Grade C dissection. Note: Treatment of the common femoral and profunda femoris is not permitted. Inflow vessel treatment can be performed with any commercially available non-DCB or non-DES device; if DCB treatment is required, SELUTION SLR 018 must be used.\n10. The BTK target lesion preparation must be documented to be successful by angiography (≤ 30% residual stenosis and no distal embolization or flow-limiting ≥ Grade C dissection) before randomization. Note: Lesion preparation can include atherectomy (rotational, orbital, directional or laser), cutting, scoring, contoured balloons or intravascular lithotripsy and PTA only.\n\nClinical Exclusion Criteria:\n\nSubjects will be excluded if any of the following criteria apply:\n\n1. Subject has extensive tissue loss (Rutherford category 6) extending above the trans metatarsal level, salvageable only with complex foot reconstruction or non-traditional trans metatarsal amputations. This includes subjects with:\n\n   1. Osteomyelitis involving proximal to the metatarsal head(s)\n   2. Any heel wound or wound with calcaneal bone involvement\n\n   d) Wounds that would require flap coverage or complex wound management for large soft tissue defect e) Full-thickness wounds on the dorsum of the foot with exposed tendon or bone\n2. Subject has chronic renal insufficiency (dialysis dependent, or glomerular filtration rate \\[GFR\\] ≤ 30 ml\u002Fmin\u002F1.73 m2 within 30 days of index procedure) or has undergone renal transplantation.\n3. Subject has acute renal insufficiency confirmed by 50% increase of serum creatinine within 48 hours before procedure and\u002For decrease in urine output.\n4. Subject has acute limb ischemia with onset of index limb symptoms less than 2 weeks prior to index procedure.\n5. Subjects has wounds that are deemed to be neuropathic or non-ischemic in nature or any venous or mixed wounds.\n6. Subject has had prior major amputation of the ipsilateral extremity or planned major amputation of either leg.\n7. Target limb iliac or common femoral artery bypass within 6 weeks of index procedure.\n8. Prior (within 14 days) or planned (within 30 days) surgical or endovascular procedures. The following procedures are permitted:\n\n   1. Target limb inflow treatment at the index procedure, provided it meets the criteria in Angiographic Inclusion Criteria #12\n   2. Contralateral limb iliac artery treatment\n   3. Diagnostic angiography\n   4. Foot wound debridement\n   5. Planned minor amputation of digit(s) at the phalangeal level\n9. Target lesion has undergone prior DCB within 1 year, or ANY prior DES or bare metal stent (BMS) treatment (no in-stent restenosis \\[ISR\\] treatment is permitted). Note: Prior stent is permitted if the target lesion is located ≥ 30 mm from the stent AND there is ≤ 30% in-stent diameter stenosis.\n10. Target lesion(s) requires treatment with alternative therapies such as thrombolysis, thrombus aspiration, stenting, cryoplasty, brachytherapy, or re-entry device. Note: The following adjunctive lesion preparation therapies are permitted: Atherectomy (rotational, orbital, directional or laser), cutting\u002Fscoring\u002Fcontoured balloon, or intravascular lithotripsy.\n11. Target lesion requires treatment via pedal access or upper extremity access.\n12. Subject has undergone non-coronary artery treatment with any limus-based drug coated balloon (DCB) or DES or other device within 3 months prior to index procedure.\n13. Subject has known hypersensitivity or allergy to Sirolimus or other pharmacologic agents required for the procedure (such as contrast agent, heparin, bivalirudin) that cannot be adequately pre-treated.\n14. Subject has contraindication to antiplatelet therapy.\n15. Subject has experienced disabling stroke or ST-segment elevation myocardial infarction (STEMI) within 3 months of index procedure.\n16. Subject has acute coronary syndrome. Stabilized Acute Coronary Syndrome (ACS) is permitted.\n17. Subject has non-atherosclerotic disease of the target vessel (including aneurysmal disease and vasculitis) or Buerger's disease.\n18. Subject has hypercoagulable state or disorder, or coagulopathy, including platelet count ≤ 100,000 per microliter.\n19. Subject has systemic infection (White Blood Count \\[WBC\\] \\> 12,000 and febrile). \\[Note: Enrollment permitted after successful treatment of infection with resolution of leukocytosis and\u002For febrile state\\].\n20. Subject is known to be immune compromised (e.g., Human Immunodeficiency virus \\[HIV\\], Systemic Lupus Erythematosus \\[SLE\\]) or is receiving treatment with immune suppressive medications (NOTE: topical corticosteroids are permitted)\n21. Subject is receiving (or is scheduled to receive) cancer treatment with surgery or chemotherapy or radiation therapy or has metastatic malignancy. Note: local application of chemotherapeutic creams is allowed.\n22. Subject has New York Heart Association (NYHA) class IV congestive heart failure.\n23. Subject is bedridden.\n24. Subject has a body mass index (BMI) \\\u003C 18.\n25. Subject is currently participating in another investigational drug or device study that has not completed primary endpoint follow-up.\n26. Subject has other anatomic, medical, social, or psychological conditions that in the investigator's opinion could limit the patient's ability to participate in the clinical study and\u002For comply with the follow-up requirements.\n\nAngiographic Exclusion Criteria:\n\nSubjects will be excluded if any of the following criteria apply:\n\n1. Presence of a previously placed stent in the target vessel(s), UNLESS the target lesion is located ≥ 30 mm from the stent AND there is ≤ 30% in-stent diameter stenosis.\n2. There is significant (\\> 50% diameter stenosis) inflow disease in the common femoral and profunda femoris arteries (inflow treatment of the common femoral and profunda femoris is not permitted).\n3. The target lesion could not be successfully pre-dilated (residual stenosis \\> 30%, distal embolization, or flow-limiting ≥ Grade C dissection after pre-dilatation).\n4. Intra-arterial thrombus, thromboembolism or atheroembolism in the index limb noted on initial diagnostic angiography or following treatment of inflow disease or pre-treatment of target lesion.\n5. Subject requires treatment of the tibial arteries distal to the tibiotalar joint line, or treatment of the pedal arteries. Angioplasty at or below the tibiotalar joint is not permitted.","ALL","18 Years",{"count":19,"type":20},376,"ESTIMATED","INTERVENTIONAL",[23],"NA","This study aims to demonstrate superior efficacy and equivalent safety of the SELUTION SLR™ DEB 014 compared to plain (uncoated) balloon angioplasty in the treatment of peripheral arterial disease (PAD) in the BTK arteries in CLTI patients.",[26,27],"Peripheral Arterial Disease","Chronic Limb-Threatening Ischemia Nos of Native Arteries of Extremities","RECRUITING","2026-04-27",{"date":31,"type":32},"2026-04-28","ACTUAL",{"date":34,"type":32},"2022-05-19",{"date":36,"type":20},"2032-07-30",{"name":38,"class":39},"M.A. Med Alliance S.A.","INDUSTRY",48,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":51,"conditions":52,"keywords":54,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},"100511990","selution-4-de-novo-small-vessel-ide-trial-100511990","NCT05946629","SELUTION 4 De Novo Small Vessel IDE Trial","A Prospective Randomized Single-Blind Multicenter Study to Assess the Safety and Effectiveness of the SELUTION SLR™ 014 PTCA Drug Eluting Balloon in the Treatment of Subjects With De Novo Coronary Lesions in Small Vessels","Inclusion Criteria:\n\n* Clinical Inclusion Criteria\n\nSubjects must meet all of the following clinical criteria to participate in the trial:\n\n1. Subject is ≥ 18 years (or the minimum legal age as required by local regulations).\n2. Female subjects of childbearing potential must have a negative pregnancy test ≤ 7 days before the procedure or are using a contraceptive device or drug.\n3. Subject presents with chronic coronary syndromes \\[CCS\\] (manifest as documented angina or positive functional testing), unstable angina or stabilized non-ST elevation myocardial infarction (NSTEMI) (biomarkers stabilized or down trending) with an indication for PCI and planned intervention.\n4. Subject can tolerate dual antiplatelet therapy with aspirin, plus either Clopidogrel, Prasugrel, or Ticagrelor. (Note: For subjects requiring oral anticoagulation, aspirin may be omitted based on investigator discretion).\n5. Subject has life expectancy \\> 1 year in the opinion of the investigator.\n6. Subject is willing and able to provide informed consent and comply with study procedures and required follow-up evaluations.\n\nPK Sub- Study Inclusion Criteria:\n\nSubjects must meet all of the main protocol inclusion criteria to participate in the PK sub-study. Subjects must also meet the following additional PK sub-study inclusion criteria:\n\n1\\. Subject is willing and able to provide informed consent for the PK sub-study and comply with the PK sub-study procedures and required follow-up evaluations.\n\nImaging Inclusion Criteria\n\nSubject's target lesion(s) must meet all of the following angiographic criteria for the subject to participate in the trial:\n\n1. A single, target lesions that meet criteria can be treated in a single vessel. No non-target lesions can be treated within the target vessel in the index procedure. Non-target lesions within the target vessel can be staged for treatment \\> 30 days from the index procedure.\n2. Up to two (2) non-target lesions in up to two (2) non-target vessels may be treated, but successful PCI of the non-target lesions must be completed before randomization and treatment of the target lesion.\n3. Target lesion is ≤ 36 mm in length.\n4. Target lesion has diameter stenosis \\> 50% and ≤ 99% with distal flow at least thrombolysis in myocardial infarction (TIMI) 2.\n5. Target vessel has RVD of ≥ 2.00 mm and ≤ 2.75 mm \\[by visual assessment\\].\n6. Target lesion is within a native coronary artery or major branch.\n7. A target lesion within a bifurcation is allowed only if a single vessel (either main vessel or side branch) is to be treated.\n8. The identified target lesion has high probability for successful treatment with approved pre-treatment techniques and DEB alone based on Investigator assessment.\n\nExclusion Criteria:\n\n* Clinical Exclusion Criteria\n\nSubjects who meet any of the following clinical criteria will be excluded from the trial:\n\n1. Subject with known hypersensitivity or allergy to Sirolimus or its analogues.\n2. Subject presents with NSTEMI and rising biomarkers, or ongoing chest pain or is hemodynamically instable.\n3. Subject with history of ST-elevation myocardial infarction (STEMI) within 30 days of the index procedure.\n4. Subject with planned major surgery within 30 days following the index procedure.\n5. Subject with planned treatment of lesion involving aorto-ostial location.\n6. Subject with PCI of a non-target vessel within ± 30 days of the index procedure.\n7. Subject with history (within 6 months prior to index procedure) of New York Heart Association (NYHA) class III or IV heart failure.\n8. Subject with history of active peptic ulcer or gastrointestinal bleeding within 6 months of the index procedure or other inability to comply with the recommended duration of dual antiplatelet therapy (DAPT).\n9. Subject is pregnant, breast-feeding or a woman of childbearing potential who plans pregnancy up to 1 year following index procedure.\n10. Subjects with current documented left ventricular ejection fraction (LVEF) \\\u003C 30%.\n11. Subject is considered not able to tolerate at least 30 seconds of coronary occlusion for the target lesion treated.\n12. Subjects is currently participating in another investigational drug or device study that has not completed primary endpoint follow-up.\n13. Subject with definite clinically active COVID-19 infection defined as a positive COVID test within 24 hours of index procedure.\n14. Subject has chronic renal insufficiency (dialysis dependent, or glomerular filtration rate \\[GFR\\] ≤ 30 ml\u002Fmin\u002F1.73 m2 within 30 days of index procedure) or had undergone renal transplantation.\n\nPK Sub-Study Exclusion Criteria:\n\nSubjects must meet none of the main protocol exclusion criteria to participate in the PK sub-study. Subjects will be excluded if any of the following additional PK sub-study exclusion criteria are met:\n\n1. Any limus family (Zotarolimus, Everolimus, Sirolimus etc.) eluting device has been placed\u002Fused in any part of the body within 3 months prior to the index procedure including non-target lesion(s) treated during the index procedure.\n2. Planned intervention with any limus family (Zotarolimus, Everolimus, Sirolimus etc.) eluting device anywhere in the body within 6 months after the index procedure. Note: staged procedures \\>30 days after index procedure (Exclusion #6 of the main protocol) are permitted only in the main protocol, and are not permitted in this PK sub-study.\n3. The subject is taking or has taken within the last 3 months any limus family medication(s) for any reason.\n4. Subject is concurrently enrolled in the main protocol angiographic registry.\n5. Subjects who are taking strong CYP3A4 Inhibitors within 14 days before the index procedure or plan to take the strong inhibitors during the study period. Strong inhibitors include: cobicistat; ritonavir; indinavir and ritonavir; itraconazole; ketoconazole; lopinavir and ritonavir; paritaprevir and ritonavir and ombitasvir (and\u002For dasabuvir); posaconazole; saquinavir and ritonavir; tipranavir and ritonavir; elvitegravir and ritonavir; telithromycin; voriconazole; ceritinib; clarithromycin; idealalisib; nefazodone; nelfinavir.\n6. Subjects who are taking strong CYP3A4 Inducers within 14 days before the index procedure or plan to take the strong inducers during the study period. Strong inducers include apalutamide; carbamazepine; enzalutamide; ivosidenib; lumacaftor and ivacaftor; mitotane; phenytoin; rifampin; St. John's wort.\n\n   * Angiographic Exclusion Criteria\n\nSubject whose target lesion(s) meet any of the following angiographic criteria will be excluded from the trial:\n\n1. Target lesion is totally occluded or has evidence of thrombus.\n2. Target lesion is located in the left main or any arterial or venous graft.\n3. Target lesion is in a side branch that is \"jailed\" by a main vessel stent.\n4. In stent restenosis",{"count":49,"type":20},960,[23],"Prospective, randomized controlled, single-blind, multicenter, clinical trial to demonstrate the safety and efficacy of the SELUTION SLR 014 PTCA DEB for treatment of de novo lesions in small coronary vessels, defined as reference vessel diameter (RVD) of 2.00 mm to 2.75 mm, in support of a pre-market approval (PMA) application to the United States (US) FDA.\n\nThe Study will enroll up to 910 randomized subjects, up to 30 subjects in a parallel angiographic substudy, and up to 20 subjects in a parallel pharmacokinetic (pK) substudy, at up to 80 sites in the US, Canada, Brazil, Japan and Europe. A minimum of 50% of the subjects will be enrolled in the US.",[53],"Coronary Artery Disease",[55,56,57,58,59,60,61,62,63,64,65,66],"CAD","DCB","DEB","NSTEMI","Stable Angina","Chronic Coronary Syndrome","CCS","Drug Coated Balloons","Drug Eluting Balloons","Small Vessels","SELUTIONSLR","Sirolimus","2025-09-25",{"date":69,"type":32},"2025-09-29",{"date":71,"type":32},"2023-10-20",{"date":73,"type":20},"2031-06",{"name":38,"class":39},43,""]