[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stent-restenosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stent-restenosis":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,47,70,95,120],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100575963","intracoronary-optical-coherence-tomography-guidance-vs-angiography-only-guidance-for-treatment-of-coronary-in-stent-restenosis-100575963",false,"NCT06779110","Intracoronary Optical Coherence Tomography Guidance Vs. Angiography Only Guidance for Treatment of Coronary In-stent Restenosis","IN-Stent RestenosIs Detection and TrEtment by Optical Coherence Tomography","INSIDE OCT","Inclusion Criteria:\n\n* Informed consent signed\n* Age ≥ 18 years\n* Referred for angiography either in stable or ACS setting suitability for PCI through femoral or radial access\n* A coronary in-stent restenosis between 70% and 99% in at least two projections in a vessel with a lumen diameter ≥ 2.25 - ≤ 5.75 mm (The severity of the stenosis should be based on visual estimation, with current online state-of-the-art angiographic equipment of the participating centres and after a mandatory dose of 50-200 mcg intracoronary of nitroglycerine.\n* Stable hemodynamics\n\nExclusion Criteria:\n\n* Inability to give informed consent\n* Participation in another clinical study with an investigational product\n* OCT pullback not technically feasible in vessel site","ALL","18 Years","99 Years",{"count":21,"type":22},360,"ESTIMATED","INTERVENTIONAL",[25],"NA","Although advances in drug-eluting stents (DES) have substantially reduced the risk of coronary in-stent restenosis (ISR) and the need for target lesion revascularisation (TLR), ISR persists. There are several treatment options for ISR (conventional balloon angioplasty, cutting or scoring balloons, drug-coated balloons, repeat DES implantation or bypass surgery). Coronary imaging is mandatory to perform PCI on ISR. Optimal coherence tomography (OCT) is an excellent option to guide PCI, but its role in ISR-PCI remains unclear. The INSIDE OCT Trial aims to compare the acute performance of PCI for ISR, either guided by OCT and angiography or by angiography alone.",[28,29,30],"Coronary Artery Disease","Stent Restenosis","STENT",[32,33],"Percutaneous Coronary Intervention (PCI)","Optimal Coherence Tomography (OCT)","RECRUITING","2025-01-12",{"date":37,"type":38},"2025-01-16","ACTUAL",{"date":40,"type":38},"2024-09-01",{"date":42,"type":22},"2028-09-01",{"name":44,"class":45},"San Luigi Gonzaga Hospital","OTHER",12,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":66,"leadSponsor":68,"locationsCount":4},"100554447","advanced-coronary-plaque-morphology-assessment-using-photon-counting-detection-and-invasive-coronary-imaging-100554447","NCT06499207","Advanced Coronary Plaque Morphology Assessment Using Photon-counting Detection and Invasive Coronary Imaging","ACDC","Inclusion Criteria:\n\n* Signed written informed consent\n* DES in proximal coronary vessel segments\n\nExclusion Criteria:\n\n\\- Any conditions that may interfere with the safety or efficacy of CCTA",{"count":55,"type":22},25,[25],"This clinical trial aims to compare non-invasive photon-counting detector computed tomography (PCD-CT) with invasive intravascular imaging (IVI) for post-interventional follow-up in patients with coronary artery disease (CAD).\n\nParticipants will undergo post-interventional follow-up using both PCD-CT and coronary angiography with IVI. Researchers will test qualitative and quantitative PCD-CT results for non-inferiority to IVI regarding stent evaluation and detection of in-stent restenosis and plaque morphology.",[28,59,60,29],"Coronary Disease","PCI","NOT_YET_RECRUITING","2024-11-18",{"date":64,"type":38},"2024-11-20",{"date":64,"type":22},{"date":67,"type":22},"2026-07-15",{"name":69,"class":45},"Medical University of Vienna",{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":23,"phases":80,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":94},"100465849","the-value-of-ivl-compared-to-opn-non-compliant-balloons-for-treatment-of-refractory-coronary-lesions-victory-trial-100465849","NCT05346068","The Value of IVL Compared To OPN Non-Compliant Balloons for Treatment of RefractorY Coronary Lesions (VICTORY) Trial","The Value of IVL Compared To OPN Non-Compliant Balloons for Treatment of RefractorY Coronary Lesions (VICTORY) Trial - A Randomized, Multicenter, Non-inferiority Comparison of Shockwave Intravascular Lithotripsy (IVL) and the OPN Non-compliant Balloon for Treatment of Calcified and Refractory Coronary Lesions","VICTORY","Clinical inclusion criteria:\n\n* Age ≥18 years and consentable;\n* Acute or chronic coronary artery disease with ischemia related symptoms (e.g. angina) and\u002For evidence of myocardial ischemia (e.g. FFR\u002F iFR, CMR, SPECT or PET-CT);\n* Angiographically-proven coronary artery disease;\n* Lesions in non-target vessels requiring PCI may be treated either\n\n  * prior to the study procedure if the procedure was unsuccessful or complicated; or\n  * in the same session if feasible and safe for the patient, otherwise a staged PCI procedure for non-target vessels may be considered;\n* Informed Consent signed by the subject.\n\nAngiographic inclusion criteria:\n\n* Single de novo target lesion stenosis of protected LMCA, or LAD, RCA or LCX (or of their branches) with\\*:\n\n  * Stenosis of ≥70%;\n  * Stenosis ≥50% and \\\u003C70% (visually assessed) with evidence of ischemia via positive stress test, or fractional flow reserve value ≤0.80, or iFR \\\u003C0.90 or IVUS minimum lumen area ≤4.0 mm²;\n* The target vessel reference diameter must be ≥2.5 mm \\& ≤4.5mm;\n* AND AT LEAST ONE OF THE FOLLOWING CRITERIA:\n\n  * Evidence of calcification at the lesion site by angiography (Grade 3), with fluoroscopic radio-opacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least one location and total length of calcium of at least 15 mm and extending partially into the target lesion,\n  * AND\u002F OR by OCT, with presence of ≥270° calcium;\n  * AND\u002F OR Prior attempt at PCI with inability to expand a balloon in target lesion.\n\nAnnotation: Only one lesion and vessel per randomized patient may be treated according to protocol and considered for the purpose of this study. The lesion considered for the study should represent the most calcified one.\n\nThe presence of any one of the following exclusion criteria will lead to the exclusion of the subject:\n\nExclusion criteria:\n\n* Patient experienced an acute STEMI or cardiogenic shock related to an acute MI within 2 days prior to index procedure;\n* Any comorbidity or condition which may reduce compliance with this protocol, including follow-up calls\u002F visits (e.g. advanced dementia);\n* Any medical, geographic, and\u002For social factor making study participation impractical or precluding required follow-up.\n* Patient is pregnant or nursing (a negative pregnancy test is required for women of child-bearing potential within 7 days prior to enrollment);\n* Unable to take a P2Y12 inhibitor (i.e. clopidogrel, prasugrel, or ticagrelor) for at least 6 months;\n* Patient has an allergy to imaging contrast media which cannot be adequately pre-medicated;\n* Renal failure with an eGFR \\\u003C30ml\u002Fmin1.73m2;\n* History of a stroke or transient ischemic attack (TIA) within 7 days, or any prior intracranial hemorrhage;\n* Active peptic ulcer or upper gastrointestinal (GI) bleeding within 6 months;\n* Untreated pre-procedural hemoglobin \\\u003C10g\u002FdL or intention to refuse blood transfusions if one should become necessary;\n* Patient has an allergy or intolerance to cobalt-chromium and\u002F or everolimus.\n* Life expectancy of less than 1 year.\n\nAngiographic exclusion criteria:\n\n* Anatomy where the device or OCT catheter are unlikely to be delivered due to tortuosity or other characteristics;\n* Target lesion is in a coronary artery bypass graft;\n* Target lesion is an in-stent restenosis (ISR);\n* Flow limiting target vessel thrombus (evident on angiography or OCT);\n* Definite or possible thrombus (by angiography or intravascular imaging) in the target vessel;\n* Evidence of aneurysm in target vessel within 10 mm of the target lesion.\n\nOf note, only qualified physicians who are investigators or a sub-investigators for the trial will assess each individual´s eligibility criteria and take the final decision to include the subject in the trial (ICH GCP 4.3.1). This decision will be documented prior to the subject receiving the first intervention.",{"count":79,"type":22},280,[25],"Percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation has become the dominant treatment strategy for patients with acute and chronic coronary artery disease (CAD) requiring revascularization. Nonetheless, PCI with stent implantation has some limitations and especially patients with severely calcified coronary lesions (approximately 10-20% of all patients with CAD) have an elevated risk for adverse outcomes, including target lesion failure (TLF) and stent thrombosis (ST).\n\nSeveral dedicated PCI devices have been developed for treatment of severely calcified lesions. Whereas especially two of them have shown promising results in smaller, prospective studies. First, the super high-pressure NC PCI balloon (OPN™ NC, SIS Medical AG, Frauenfeld, Switzerland) has been shown to represent an effective and safe device for lesion preparation. Second, the lately introduced Shockwave intravascular lithotripsy (IVL)™ balloon catheter (Shockwave Medical, Santa Clara, CA, USA) appears to be a safe and efficient alternative device for treatment of calcified coronary lesions. However, it remains unknown, if the OPN™ NC balloon is non-inferior to to IVL regarding lesion preparation and completeness of stent expansion in severely calcified lesions.",[59,28,83,29,84],"Calcific Coronary Arteriosclerosis","Coronary Artery Calcification","2024-06-16",{"date":87,"type":38},"2024-06-18",{"date":89,"type":38},"2022-11-22",{"date":91,"type":22},"2028-05-30",{"name":93,"class":45},"Luzerner Kantonsspital",1,{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":17,"minAge":101,"maxAge":102,"enrollmentInfo":103,"targetDuration":4,"studyType":23,"phases":105,"briefSummary":107,"conditions":108,"keywords":109,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":4},"100524691","phase-4-clinical-study-of-tongxinluo-capsule-in-preventing-and-treating-restenosis-after-intracranial-and-external-arterial-stenting-100524691","NCT06112028","Clinical Study of Tongxinluo Capsule in Preventing and Treating Restenosis After Intracranial and External Arterial Stenting","Inclusion Criteria:\n\n* The diagnosis of symptomatic cerebral artery stenosis study participants met the above diagnostic criteria; Participants in the study with asymptomatic cerebral artery stenosis or asymptomatic cerebral artery stenosis met the indications for stent implantation in the Chinese Guidelines for Intravascular Interventional Treatment of Ischemic Cerebrovascular Diseases 2015, and successfully underwent cerebrovascular stenting (residual stenosis after vascular opening ≤30% after stent implantation).\n\n  * I am 45-80 years old and I and my family members agree to participate in this study.\n\n    * It can tolerate statin and platelet therapy without serious complications.\n\nExclusion Criteria:\n\n* Patients with other intracranial lesions;\n\n  * Recent bleeding history or bleeding tendency;\n\n    * Patients with severe cardiac, liver and renal insufficiency, hypertension and diabetes were not well controlled;\n\n      (4) Severe symptoms of stroke or neurological impairment and unstable symptoms after surgery;\n\n      (5) Severely infected persons who cannot be controlled;\n\n      ⑥ Patients who stop taking medicine for more than 2 months for various reasons;\n\n      ⑦ Taking proprietary Chinese medicine or traditional Chinese medicine with similar efficacy.","45 Years","80 Years",{"count":104,"type":22},200,[106],"PHASE4","Intrastent restenosis is a common complication after intracranial and extracranial arterial stenting and an important cause of recurrent ischemic stroke. Studies have shown that Tongxinluo capsule can protect the injured inner cells, reduce inflammation, inhibit the proliferation and migration of smooth muscle cells, inhibit the proliferation of plaque and nourish blood vessels, and resist arteriosclerosis. This study was a multicenter prospective randomized controlled clinical trial. Participants with intracranial and extracranial atherosclerotic stenosis who successfully underwent arterial stenting were included in the study, and were divided into Tongxinluo test group and control group. Clinical and related auxiliary examination data were collected at each follow-up point. To explore the effectiveness and potential mechanism of Tongxinluo capsule in preventing and treating restenosis after intracranial and external arterial stenting, and to provide reference for expanding clinical use of traditional Chinese medicine.",[29],[110,29],"traditional Chinese medicine","2023-10-26",{"date":113,"type":38},"2023-11-01",{"date":115,"type":22},"2023-10",{"date":117,"type":22},"2026-11",{"name":119,"class":45},"Yanbin Li",{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":124,"acronym":125,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":127,"targetDuration":4,"studyType":23,"phases":129,"briefSummary":130,"conditions":131,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":94},"100458054","copenhagen-mesenteric-stent-study---a-randomized-trial-of-stent-versus-covered-stent-treatment-for-chronic-mesenteric-ischemia-100458054","NCT05244629","Copenhagen Mesenteric Stent Study - A Randomized Trial of Stent Versus Covered Stent Treatment for Chronic Mesenteric Ischemia","COMESS","Inclusion Criteria:\n\n* Patients with symptomatic CMI of atherosclerotic or atherothrombotic etiology\n* Intended endovascular treatment\n* Symptoms consistent with CMI (pain, weight loss, diarrhea)\n* Significant ostial stenosis (\\>50%) of the superior mesenteric artery on CTA\n* Significant stenosis on angiography (\\>50% or \\>15mmHg pressure gradient)\n* Patients \\> 18 years\n\nExclusion Criteria:\n\n* No informed consent\n* Non atherosclerotic cause of MI\n* Acute mesenteric ischemia (AMI)\n* Signs of acute bowel ischemia, peritonitis, laparotomy, sepsis\n* Previous stent treatment in the superior mesenteric artery(ies)\n* Target artery lesions \\>4cm in length\n* Unable to cross lesion with guidewire\n* Non-significant stenosis angiographically\n* Pregnancy\n* Allergies to contrast media or stent materials",{"count":128,"type":22},98,[25],"Chronic mesenteric ischemia (CMI) is often caused by narrowings in the arteries providing blood to the intestines. Endovascular stent placement is considered the preferred treatment for this condition. Guidelines increasingly support the use of so called covered stents (CS) in stead of bare stents (BMS) for this use but the level of evidence for this is limited. Using CS incur additional costs for healthcare short-term but may prevent recurrence of narrowing and symptoms postoperatively benefitting patients and healthcare.\n\nStudy Objective:\n\nTo evaluate the outcomes after stenting of mesenteric arteries using BMS or CS.\n\nStudy Outcome:\n\nPrimary stent patency 1 year after placement\n\nThe trial will also evaluate complications, how often stents need to be reoperated, Quality of Life (QoL) and reasons for subjects death\n\nMethod:\n\nThis is a so called prospective, randomized controlled trial comparing CS vs. BMS. This means that one patients have agrred to treatment they will be randomly selected for treatment with either CS or BMS . The stent metal structure is identical in the two implants and the only difference is the graft covering, making this study unique.\n\nThe study will also collect blood samples for a biobank that will be used to study markers of disease and how these effect treatment outcomes.\n\nAll patients referred to the Department of Vascular Surgery due to CMI are considered for inclusion if they havechronic symptoms consistent with CMI, significant stenosis or occlusion of the superior mesenteric artery and are \\> 18 years Subjects not able to provide informed consent or who have non atherosclerotic cause of CMI, signs of acute loss of blood flow to the intestines cannot participate. Previous stent treatment in the superior mesenteric artery, pregnancy, allergies to contrast or stent materials are also reasons for not being included in this trial.\n\nSide effects, risks and disadvantages for participants The risk for procedure-related complications is less than 5% and similar in both study groups. Most short-term complications are related to vascular access sites and consist of local bleeding and thrombosis. Other potential complications include impaired renal function due to contrast use, contrast allergy, arterial dissection and death.",[132,133,134,135,29,136,137,138,139,140],"Mesenteric Ischemia","Bowel; Ischemic","Superior Mesenteric Atherosclerosis","Mesenteric Artery Stenosis","Stent Occlusion","Stent Thrombosis","Stent-Graft Stenosis","Stent-Graft Thrombosis","Stent-Graft Restenosis","2023-06-09",{"date":143,"type":38},"2023-06-12",{"date":145,"type":22},"2023-06",{"date":147,"type":22},"2029-08",{"name":149,"class":45},"Rigshospitalet, Denmark"]