[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Concept Medical Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":196},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,57,88,123,150,170],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":4},"100620606","phase-2-a-study-comparing-the-magictouch-sirolimus-coated-balloon-with-a-paclitaxel-coated-balloon-for-treating-severe-narrowing-or-blockage-in-the-femoropopliteal-arteries-100620606",false,"NCT07359807","A Study Comparing the MAGICTouch™ Sirolimus-coated Balloon With a Paclitaxel-coated Balloon for Treating Severe Narrowing or Blockage in the Femoropopliteal Arteries.","MAGICTouchTM PTA Sirolimus-Coated BALloon vs Paclitaxel Coated Balloon for Treatment of High-grade Stenotic or Occluded Lesions in Femoro-Popliteal Arteries","MAGICAL SFA","Inclusion Criteria:\n\n* Subject age ≥ 21 years\n* Subject has been informed of the nature of the trial, the duration of the trial, agrees to attend follow-up visits, agrees to complete the required testing, agrees to participate, and has signed an informed consent form.\n* Rutherford category 2-4 according to the investigator's subjective evaluation\n* Subject has de-novo or re-stenosed lesion with ≥ 70% stenosis documented angiographically, and no prior stent in the target lesion.\n* Target lesion length is ≥ 40mm and ≤ 200mm by visual estimate of the treating physician.\n* Multiple lesions with max. A 30mm healthy vessel segment between lesions can be considered, at the treating physician's discretion, as one lesion. Total lesion length should not exceed 200mm.\n* Reference vessel diameter (RVD) ≥ 4mm and ≤ 7 mm by visual estimation.\n* Patency of P2 and P3 segments of the popliteal artery and at least one (1) infra-popliteal artery to the ankle (\\\u003C 50% diameter stenosis) in continuity with the femoropopliteal artery.\n* Patency of the ipsilateral iliac artery (≤ 30% diameter stenosis). Iliac artery stenosis \\> 30% may be treated during the index procedure to ensure sufficient inflow.\n* Staged Intervention of the contralateral limb is permitted at +\u002F- 30 days.\n* A subject can only be enrolled and randomized once with only one target lesion in the MAGICAL SFA trial. Note that only the lesion in one limb can be treated as a target lesion for the index procedure.\n\nExclusion Criteria:\n\n* Failure of the guidewire to successfully cross the target lesion or subintimal target lesion.\n* Flow-limiting dissection after pre-dilatation and\u002For residual stenosis \\> 30% prior to randomization.\n* Angiographic evidence of severe calcification of the target vessel (contiguous calcification on both sides of the vessel).\n* Presence of fresh\u002Forganized thrombus in the target lesion.\n* Presence of aneurysm in the target vessel\u002Fs.\n* Prior vascular surgery (including atherectomy , bypass surgery) of the target limb.\n* Prior stent in the target lesion.\n* Stroke or heart attack within three months prior to enrollment.\n* Any vascular surgical procedure or intervention performed in the target limb within 30 days prior to or planned within 30 days post index procedure.\n* Any vascular treatment with PTX or sirolimus-coated devices 60 days prior to the index procedure.\n* Target lesion requires treatment with alternative therapies such as primary stenting, laser, lithotripsy, thrombectomy, atherectomy, and\u002For cryoplasty brachytherapy re- entry devices.\n* Enrolled in another investigational drug, device, or biologic trial where the primary end point is not yet achieved.\n* Life expectancy of less than one year in the investigator's opinion.\n* Known allergies or sensitivity to heparin, aspirin, other anticoagulant\u002Fantiplatelet therapies, sirolimus, paclitaxel, or contrast media that cannot be adequately pre- treated prior to index procedure.\n* Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy.\n* Receiving dialysis or immunosuppressant therapy . (A systemic corticosteroid therapy with expected maximum dosage of 5mg prednisolone or equivalent, per day, during the initial 9 months after procedure, is allowed.)\n* Subjects with severe (Stage 4) renal disease, defined as eGFR \\\u003C 30%.\n* Pregnant or lactating females .\n* History of major amputation in the target lesion limb.","ALL","21 Years",{"count":20,"type":21},478,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE2","PHASE3","Percutaneous Transluminal Angioplasty (PTA), in which a balloon is advanced and inflated in the obstructed artery for several seconds to minutes, has become the standard endovascular treatment for peripheral arteries. The long-term success of bare balloon PTA in the femoropopliteal segment is hampered by the occurrence of restenosis, which can be reduced by local antiproliferative drug delivery via the PTA balloon catheter.\n\nThe rationale of this trial is based on the hypothesis that the usage of the MagicTouch drug-coated balloon (DCB) is at least equal (non-inferior) with regard to efficacy and safety in comparison with a clinically well-established paclitaxel drug-coated balloon (PTX DCB).\n\nThe objective of this prospective, randomized, multi-center trial is to compare the Magic Touch® DCB with PTX DCBs for treatment of high-grade stenotic or occluded lesions in supeficial femoral artery (SFA) and\u002For P1 segment of the popliteal artery in PAD patients.",[28,29],"Popliteal Artery Disease","Superficial Femoral Artery Disease",[31,32,33,34,35,36,37,38,39,40,41,42,43,44],"SFA","Sirolimus","Paclitaxel","Drug-eluting","Angioplasty","Balloon","MagicTouch","PAD","Peripheral Arterial Disease","Stenotic","Stenosis","Occlusion","Superfical Femoral Artery","Popliteal Artery","NOT_YET_RECRUITING","2026-04-14",{"date":48,"type":49},"2026-04-17","ACTUAL",{"date":51,"type":21},"2026-04",{"date":53,"type":21},"2033-01",{"name":55,"class":56},"Concept Medical Inc.","INDUSTRY",{"id":58,"slug":59,"hasResults":11,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":65,"targetDuration":4,"studyType":22,"phases":67,"briefSummary":69,"conditions":70,"keywords":74,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},"100530101","sirolimus-coated-balloon-versus-standard-balloon-angioplasty-in-the-treatment-of-below-the-knee-arterial-disease-100530101","NCT06182397","Sirolimus Coated BALloon Versus Standard Balloon Angioplasty in The Treatment of Below The Knee Arterial Disease","MAGICAL BTK: Randomized Controlled Trial of MAGIcTouch - Sirolimus Coated BALloon Versus Standard Balloon Angioplasty in The Treatment of Below The Knee Arterial Disease","MAGICAL BTK","Inclusion Criteria:\n\n1. Age ≥ 21 years or minimum age (is allowed the inclusion of subjects \\> 21 years OR adulthood minimum age (depending on the US state regulations)\n2. Rutherford class 4 with documented WIFI score, not exceeding more than 30% of target patient population.\n3. Rutherford class 5 to 6 in the target limb with documented WIFI score.\n\n   Intraoperative Inclusion Criteria:\n4. Single or sequential de novo or re-stenotic lesions (stenosis of \\> 50% or occlusions) from 2 to 20cm in the proximal 200mm of below the knee arteries. Lesion is considered as one lesion if there is maximum of 30 mm gap between lesions at discretion of investigator. Below the knee arteries are Tibio-peroneal trunk, Peroneal bifurcation, anterior tibial artery, posterior tibial artery and peroneal artery. With documented Distal Run off a maximum of two tibial vessels can be treated in the index procedure. Inflow free from flow limiting lesions (\\\u003C50% stenosis) confirmed by duplex or angiography. Subjects with flow limiting inflow lesions (\\>50% stenosis) can be included if lesion had been treated successfully (\\\u003C30% residual stenosis) before or during the index procedure.\n5. Target vessel has angiographically documented unimpaired (\\\u003C50% stenosis) run off into a named Tibio-pedal artery (Peroneal, Anterior Tibial\u002F Dorsalis Pedis\u002F Posterior Tibial Artery)\n\nExclusion Criteria:\n\n1. Comorbid conditions limiting life expectancy ≤ 1 year\n2. Subject is currently participating in another investigational drug or device study that has not reached first primary endpoint yet\n3. Subject is lactating, pregnant or planning to become pregnant during the course of the study\n4. Subject with extensive tissue loss salvageable only with complex foot reconstruction or non-traditional trans metatarsal amputation. This includes subjects with:\n\n   1. Osteomyelitis including and\u002For proximal to the metatarsal head\n   2. Gangrene involving the plantar skin of the forefoot, midfoot,or heel\n   3. Deep ulcer or large shallow ulcer (\\> 3 cm) involving the plantar skin of the forefoot, midfoot, or heel\n   4. Full thickness heel ulcer with\u002Fwithout calcaneal involvement\n   5. Any wound with calcaneal bone involvement\n   6. Wounds that are deemed to be neuropathic or non-ischemic in nature\n   7. Wounds that would require flap coverage or complex wound management for large soft tissue defect\n   8. Full thickness wounds on the dorsum of the foot with exposed tendon or bone\n5. Prior bypass surgery of target vessel\n6. Planned amputation of the target limb (major)\n7. Previously implanted stent in the target lesion\n8. Vulnerable or protected adults\n9. Bleeding diathesis or another disorder (i.e. gastrointestinal ulceration,etc) which would prevent the use of mandated antiplatelet agents\n10. Known allergy to sirolimus\n11. Subjects with severe (Stage 4) renal disease, defined eGFR \\\u003C 30.\n\n    Intraoperative exclusion criteria:\n12. Failure to successfully cross the target lesion with a guide wire\n13. Target vessel has lesions extending beyond the ankle joint\n14. Failure to obtain \\\u003C30% residual stenosis prior to randomization\n15. Lesions requiring treatment through retrograde access . Retrograde wire crossing is allowed but treatment must be performed from the antegrade approach.\n16. Use of commercially available DCBs, bare metal stents, drug eluting stents, specialty balloons or atherectomy devices at the target lesions. (Non-compliant balloons are not considered specialty balloons). For Inflow and non-target lesions all the approved devices are allowed.",{"count":66,"type":21},368,[68],"NA","This is a Pivotal, Prospective, randomized, two arm, placebo controlled, single-blind, multicenter trial that will be conducted at approximately 80 sites; approx. 50 sites with at least 50% of subjects will be recruited from USA and approx. 30 sites OUS - Europe, Australia and Asia. Each site will be capped at 30 maximum subjects recruited.\n\nThe main goal of this clinical trial is to determine the effectiveness and safety of the sirolimus drug coated balloon (DCB) versus standard percutaneous transluminal angioplasty (PTA) for the treatment of below the knee arterial disease.\n\nEligible subjects will be randomised in a 1:1 allocation ratio and stratified by recruiting countries. Each subject will be randomized to receive either:\n\n1. MagicTouch PTA sirolimus coated balloon catheter (DCB) in addition to standard balloon angioplasty or\n2. Placebo balloon angioplasty in addition to standard balloon angioplasty (PTA).",[71,72,73],"Arterial Disease of Legs","Below-the-knee Obstruction","PAD - Peripheral Arterial Disease",[75,76,35,77],"below the knee","PTA","lower limb","RECRUITING","2025-12-30",{"date":81,"type":49},"2026-01-02",{"date":83,"type":49},"2025-01-16",{"date":85,"type":21},"2031-02-01",{"name":55,"class":56},29,{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":17,"minAge":96,"maxAge":97,"enrollmentInfo":98,"targetDuration":4,"studyType":22,"phases":100,"briefSummary":101,"conditions":102,"keywords":106,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},"100536958","magictouchsirolimus-coated-balloon-for-treatment-of-coronary-artery-lesions-in-small-vessels-100536958","NCT06271590","MagicTouch™Sirolimus-Coated Balloon for Treatment of Coronary Artery Lesions in Small Vessels","The MAGICAL SV Trial - A Prospective, Multicenter, Randomized, Two-Arm, Single-blind Non Inferiority Trial to Evaluate the Safety and Efficacy of the MagicTouch™ Sirolimus-Coated Balloon in the Treatment of Small Vessels in Patients With Coronary Artery Disease.","MAGICAL SV","Clinical Inclusion Criteria:\n\n1. Adult patient with an indication for PCI due to stable angina, NSTEACS, post-infarction angina or silent ischemia (in absence of symptoms a visually estimated target lesion diameter stenosis of ≥70%, a positive non-invasive stress test, FFR ≤0.80, or non-hyperemic pressure ratio \\[NHPR\\] ≤0.89 must be present)\n2. Subject is ≥18 and \\\u003C80 years old\n3. Subject is willing to comply with all protocol-required follow-up evaluations and provides written informed consent\n\n   Angiographic Inclusion Criteria:\n4. Target reference vessel diameter (visual estimation) ≤2.75 mm\n5. Successful lesion preparation (residual stenosis \\\u003C30%), without flow-limiting complications (no or slow flow, dissection etc.)\n6. Target lesion(s) in a native coronary artery\n7. Up to two small vessel target lesions in two different vessels\n8. Target lesion length (visual estimation): ≥6.0 and ≤34.0 mm and can be covered by a single 40 mm balloon\n9. Target lesion diameter stenosis (visual estimation) \\>30% and \\\u003C100% with Thrombolysis in Myocardial Infarction (TIMI) flow grade ≥2\n\nClinical Exclusion Criteria:\n\n1. Planned (staged) intervention in the target vessel\n2. ST-segment-elevation MI within 48 hours prior to index procedure\n3. Subjects with acute cardiac decompensation or cardiogenic shock\n4. Subject with a life expectancy of less than 24 months\n5. Impaired renal function (glomerular filtration rate \\[GFR\\] \\\u003C30 mL\u002Fmin)\n6. Documented left ventricular ejection fraction (LVEF) ≤30%\n7. Known allergies to acetylsalicylic acid, clopidogrel, prasugrel, ticagrelor, heparin, contrast medium, sirolimus or similar drugs (i.e., ABT-578 \\[Zotarolimus\\], biolimus, tacrolimus)\n8. Relative or absolute contraindication to dual antiplatelet therapy (DAPT) for at least 1 month (e.g., planned surgeries that cannot be delayed)\n9. Subject has an indication for chronic oral anticoagulation treatment and a contraindication for concomitant treatment with a P2Y12 inhibitor\n10. If femoral access is planned, significant peripheral arterial disease which precludes safe insertion of a 6F sheath\n11. Hemoglobin \\\u003C9 g\u002FdL\n12. Platelet count \\\u003C100,000 cells\u002Fmm3 or \\>700,000 cells\u002Fmm3\n13. White blood cell count \\\u003C3,000 cells\u002Fmm3\n14. Active infection undergoing treatment\n15. Clinically significant liver disease\n16. Cerebrovascular accident (CVA) within 3 months or has any permanent neurological defect as a result of CVA\n17. Subject is receiving oral or intravenous immunosuppressive therapy (e.g., inhaledsteroids are not excluded) or has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, but not including diabetes mellitus)\n18. Subject is unlikely to comply with the follow up requirements, per investigator's assessment\n19. Subject currently enrolled in other investigational device or drug trial in which primary endpoint has not been reached\n20. Pregnant and\u002For breast-feeding females or females who intend to become pregnant during the time of the study\n\n    Angiographic Exclusion Criteria:\n\n    All exclusion criteria apply to the target lesion(s) or target vessel(s)\n21. Re-stenotic lesion(s), whether due to percutaneous old balloon angioplasty (POBA) or prior stenting\n22. True bifurcation lesion (lesion involves both main and side branch\\>2.5 mm) with planned treatment of both branches per investigator assessment\n23. Angiographic evidence of thrombus in the target vessel\n24. Myocardial bridging\n25. Target lesion is heavily calcified\n26. Diffuse distal disease to target lesion with impaired runoff, TIMI flow \\\u003C2\n27. Non-target lesion in the target vessel requiring PCI\n\nNote: Non-target vessel PCI is allowed at the time of index procedure if performed prior to study intervention and if successful and uncomplicated. For target lesions located in branches of the three main vessels (left anterior descending artery \\[LAD\\], left circumflex artery \\[LCx\\], right coronary artery \\[RCA\\]), the term target vessel refers to the branch and not the main vessel.","18 Years","80 Years",{"count":99,"type":21},1605,[68],"This is a multicenter, randomized, single-blind pivotal study to evaluate the safety and efficacy of the MagicTouchTM Drug coated balloon in treatment of small vessels in patients with coronary artery disease. The objective is to establish the safety and efficacy of the Magic TouchTM Drug coated balloon in treatment of small vessels (≤2.75 mm).\n\nA total of 1605 subjects will be enrolled in a maximum of 50 study sites located in North America. Additional sites located in Europe and South America may also participate in the study, with non-US sites contributing a maximum of \\~50% of enrollees.",[103,104,105],"Coronary Artery Disease","Native Coronary Artery Stenosis","Cardiovascular Diseases",[107,108,109,110,111,112,113,94],"Drug coated balloon","Sirolimus coated balloon","De Novo","Magic Touch","SCB","Concept Medical","Small Vessel","2025-09-04",{"date":116,"type":49},"2025-09-11",{"date":118,"type":49},"2025-05-20",{"date":120,"type":21},"2031-11",{"name":55,"class":56},24,{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":131,"targetDuration":4,"studyType":22,"phases":133,"briefSummary":134,"conditions":135,"keywords":139,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":149},"100401744","sirolimus-coated-balloon-versus-standard-balloon-for-sfa-and-popliteal-artery-disease-100401744","NCT04511234","Sirolimus Coated Balloon Versus Standard Balloon for SFA and Popliteal Artery Disease","Randomized Controlled Trial of First Sirolimus Coated Balloon Versus Standard Balloon Angioplasty in The Treatment of Superficial Femoral Artery and Popliteal Artery Disease","FUTURE-SFA","Inclusion Criteria:\n\n1. Age ≥ 21 years or minimum age\n2. Rutherford class 3 to 6 in the target limb\n\n   Intraoperative Inclusion Criteria\n3. Single or sequential de novo or re-stenotic lesions (stenosis of \\> 50% or occlusions) from 2 to 20cm in the femoropopliteal arteries. Lesion is considered as one lesion if there is maximum of 30mm gap between lesions at discretion of investigator. Femoropopliteal arteries are superficial femoral artery, popliteal artery P1 and P2\n4. Inflow free from flow limiting lesions (\\\u003C50% stenosis) confirmed by duplex or angiography. Subjects with flow limiting inflow lesions (\\>50% stenosis) can be included if lesion had been treated successfully (\\\u003C30% residual stenosis) before or during the index procedure.\n5. At least one non-occluded crural vessel (ie. without significant stenosis) with angiographically documented run off to the foot.\n\nExclusion Criteria:\n\n1. Comorbid conditions limiting life expectancy ≤ 1 year\n2. Subject is currently participating in another investigational drug or device study that has not reached first primary endpoint yet\n3. Subject is pregnant or planning to become pregnant during the course of the study\n4. Heel gangrene\n5. Prior bypass surgery of target vessel\n6. Planned amputation of the target limb\n7. Previously implanted stent in the target lesion\n8. Vulnerable or protected adults\n9. Bleeding diathesis or another disorder such as gastrointestinal ulceration which restrict the use of clopidogrel or aspirin\n10. Known allergy to sirolimus\n\n    Intraoperative Exclusion Criteria\n11. Failure to successfully cross the target lesion with a guide wire (successful crossing means tip of the guide wire distal to the target lesion in the absence of flow limiting dissections or perforations)\n12. Failure to obtain \\\u003C30% residual stenosis in a pre-existing lesion\n13. Highly calcific lesions\n14. Use of DCBs, drug eluting stent, specialty balloons or artherectomy devices during the index procedure. (Non-compliant balloons are not considered specialty balloons)\n15. Lesions requiring retrograde access (SAFARI)",{"count":132,"type":21},279,[68],"This study aims to conduct a randomized, double blind, randomised controlled multicentre trial of sirolimus drug coated balloon versus standard percutaneous transluminal angioplasty for the treatment of superficial and popliteal arterial disease.",[136,137,138],"Peripheral Artery Disease","Atherosclerosis","Arterial Disease",[38,140,76,32],"DCB","2025-06-30",{"date":143,"type":49},"2025-07-03",{"date":145,"type":49},"2020-09-08",{"date":147,"type":21},"2026-12",{"name":55,"class":56},20,{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":156,"eligibilityCriteria":157,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":158,"targetDuration":4,"studyType":22,"phases":160,"briefSummary":161,"conditions":162,"keywords":163,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":164,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":149},"100401745","sirolimus-coated-balloon-for-the-treatment-of-below-the-knee-arterial-disease-100401745","NCT04511247","SirolimUs CoaTed Balloon for The TrEatment of Below The Knee Arterial Disease","FUTURE BTK: Randomized Controlled Trial of First SirolimUs CoaTed Balloon VersUs StandaRd Balloon Angioplasty in The TrEatment of Below The Knee Arterial Disease","FUTURE-BTK","Inclusion Criteria:\n\n1. Age ≥ 21 years or minimum age\n2. Rutherford class 4 to 6 in the target limb\n\n   Intraoperative Inclusion Criteria\n3. Single or sequential de novo or re-stenotic lesions (stenosis of \\> 50% or occlusions) from 2 to 20cm in the proximal 200mm of below the knee arteries. Lesion is considered as one lesion if there is maximum of 30mm gap between lesions at discretion of investigator. Below the knee arteries are tibioperoneal trunk, anterior tibial artery, posterior tibial artery and peroneal artery\n4. Inflow free from flow limiting lesions (\\\u003C50% stenosis) confirmed by duplex or angiography. Subjects with flow limiting inflow lesions (\\>50% stenosis) can be included if lesion had been treated successfully (\\\u003C30% residual stenosis) before or during the index procedure.\n5. Target vessel has angiographically documented run off to the foot after treatment (ie. without significant stenosis)\n\nExclusion Criteria:\n\n1. Comorbid conditions limiting life expectancy ≤ 1 year\n2. Subject is currently participating in another investigational drug or device study that has not reached first primary endpoint yet\n3. Subject is pregnant or planning to become pregnant during the course of the study\n4. Heel gangrene\n5. Prior bypass surgery of target vessel\n6. Planned amputation of the target limb\n7. Previously implanted stent in the target lesion\n8. Vulnerable or protected adults\n9. Bleeding diathesis or another disorder such as gastrointestinal ulceration which restrict the use of clopidogrel or aspirin\n10. Known allergy to sirolimus\n\n    Intraoperative Exclusion Criteria\n11. Failure to successfully cross the target lesion with a guide wire (successful crossing means tip of the guide wire distal to the target lesion in the absence of flow limiting dissections or perforations).\n12. Target vessel has lesions extending beyond the ankle joint\n13. Failure to obtain \\\u003C30% residual stenosis in a pre-existing lesion\n14. Lesions requiring retrograde access (SAFARI)\n15. Highly calcified lesions (Contiguous calcification on both sides of the lesion)\n16. Use of DCBs, drug eluting stent, specialty balloons or artherectomy devices during the index procedure. (Non-compliant balloons are not considered specialty balloons)",{"count":159,"type":21},219,[68],"This study aims to conduct a randomized, double blind, randomised controlled multicentre trial of sirolimus drug coated balloon versus standard percutaneous transluminal angioplasty for the treatment of below the knee arterial disease.",[136,137,71],[38,140,76,32],{"date":143,"type":49},{"date":166,"type":49},"2020-08-15",{"date":168,"type":21},"2027-12",{"name":55,"class":56},{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":176,"eligibilityCriteria":177,"healthyVolunteers":11,"sex":17,"minAge":96,"maxAge":178,"enrollmentInfo":179,"targetDuration":4,"studyType":22,"phases":181,"briefSummary":182,"conditions":183,"keywords":185,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":195},"100509046","magictouch-for-treatment-of-in-stent-restenosis-in-coronary-artery-lesions-100509046","NCT05908331","MagicTouch for Treatment of In-Stent Restenosis in Coronary Artery Lesions","MagicTouch Sirolimus-coated Balloon for Treatment of In-Stent Restenosis in Coronary Artery Lesions","MAGICAL ISR","Inclusion Criteria:\n\n1. Subject is at least 18 years old\n2. Subject (or legal guardian) understands the trial requirements and treatment procedures and provides written informed consent prior to any trial-specific tests or treatment\n3. Patient with an indication for PCI due to suspected in-stent restenosis\n4. Non-target lesion PCI are allowed in non-target vessels to be treated with approved interventional devices prior to randomization as follows:\n\nAngiographic Inclusion Criteria:\n\n1. In-stent restenosis after drug-eluting stent implantation(s) in the target lesion (i.e. single and multiple stent layer ISR cases are eligible)\n2. Target lesion must have visually estimated stenosis ≥50% and less than 100% diameter stenosis in symptomatic patients; or a visually estimated target lesion diameter stenosis of ≥70%, or by evidence of ischemia by coronary physiology (fractional flow reserve \\[FFR\\] ≤0.80 or non-hyperemic pressure ratio \\[NHPR\\] ≤0.89) in absence of symptoms\n3. Successful lesion preparation (residual stenosis \\\u003C30%), without complications (no or slow flow, flow-limiting dissection, perforation, distal embolization) and without plan for stenting\n4. Target lesion in a native coronary artery\n5. Thrombolysis In Myocardial Infartction (TIMI) grade flow ≥1 in target lesion\n6. Target reference vessel diameter (visual estimation) \\>2.0 and ≤4.0 mm\n7. Target lesion length (including tandem lesions) ≤36.0 mm (visual estimation) and can be covered by only one balloon\n8. One ISR target lesion (overlapping stents are allowed) to be treated per patient and in single major coronary artery or side branch (reference vessel diameter \\>2.0 mm)\n9. Other coronary lesions (ISR or non-ISR) in non-target vessel are allowed and may be treated by any approved interventional device, but must be treated successfully prior to randomization\n\nExclusion Criteria:\n\nGeneral Exclusion Criteria (all must be absent for the patient to be eligible):\n\n1. STEMI within 72 hours of presentation to the first treating hospital, whether a transfer facility or the study hospital\n2. NSTEACS in whom the biomarkers have not peaked\n3. PCI within the 24 hours prior to the index procedure (not including PCI performed in non-target lesions during the index procedure)\n4. Prior DCB treatment (coronary or off-label peripheral) of target lesion ISR\n5. Cardiogenic shock (defined as persistent hypotension \\[systolic blood pressure \\\u003C90 mm Hg\\] or requiring vasoactive or hemodynamic support, including IABP)\n6. Subject is intubated\n7. Known left ventricular ejection fraction \\\u003C30%\n8. Relative or absolute contraindication to DAPT for at least 1 month (e.g., planned surgeries that cannot be delayed)\n9. Subject has an indication for chronic oral anticoagulation treatment and a contraindication for concomitant treatment with a P2Y12 inhibitor\n10. If femoral access is planned, significant peripheral arterial disease which precludes safe insertion of a 6F sheath\n11. Hemoglobin \\\u003C9 g\u002FdL\n12. Platelet count \\\u003C100,000 cells\u002Fmm3 or \\>700,000 cells\u002Fmm3\n13. White blood cell count \\\u003C3,000 cells\u002Fmm3\n14. Active infection undergoing treatment\n15. Clinically significant liver disease\n16. Renal insufficiency as defined by estimated glomerular filtration rate (eGFR) to be \\\u003C30ml\u002Fmin by the MDRD formula\n17. Active peptic ulcer or active bleeding from any site\n18. Bleeding from any site requiring active medical attention within the prior 8 weeks\n19. History of bleeding diathesis or coagulopathy or likely to refuse blood transfusions\n20. Cerebrovascular accident (CVA) within 3 months or has any permanent neurological defect as a result of CVA\n21. Known allergy to the study device components or protocol-required concomitant medications:\n\n    \\- sirolimus (as well as other limus drugs, analogues, or similar compounds), aspirin, clopidogrel and prasugrel and ticagrelor, heparin and bivalirudin, or iodinated contrast that cannot be adequately pre-medicated\n22. Any co-morbid condition that may cause non-compliance with the protocol (e.g. dementia, substance abuse, etc.) or reduce life expectancy to \\\u003C24 months (e.g. cancer, heart failure, lung disease, severe valvular disease)\n23. Patient is participating in or plans to participate in any other investigational drug or device trial that has not reached its primary endpoint\n24. Women who are pregnant or breastfeeding (women of child-bearing potential must have a negative pregnancy test within one week before index procedure)\n25. Women who intend to become pregnant within 12 months after the index procedure\n26. Patient has received an organ transplant or is on a waiting list for an organ transplant\n27. Patient has received chemotherapy within 30 days before the index procedure or scheduled to receive chemotherapy any time after the index procedure\n28. Patient is receiving oral or intravenous immunosuppressive therapy or has known life-limiting immunosuppressive or autoimmune disease. Inhaled steroid and steroid use for contrast- allergy prophylaxis or treatment are allowed\n\nAngiographic Exclusion Criteria (visual estimate) (all must be absent for the patient to be eligible):\n\n1. More than 1 ISR lesion in the target vessel in segments that cannot be treated by a single 40mm length DCB (see Angiographic Inclusions #5 and #6 above)\n2. ISR lesion in the target vessel in a segment that corresponds to a previously established\u002Fdocumented bare metal stent (BMS)\n3. Unprotected left main lesions \\>50% or left main intervention\n4. Primary PCI for STEMI\n5. Coronary artery disease judged more suitable for surgical revascularization per guidelines and local heart team discussion\n6. Another lesion in either the target vessel or non-target vessel is present that requires or has a high probability of requiring PCI within 12 months after the index procedure\n7. Prior brachytherapy or DCB treatment of target lesion\n8. Target lesion is a bifurcation restenosis involving both branches of a bifurcation in which the side branch reference vessel diameter is \\>2.0 mm\n9. Target lesions located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft\n10. Target lesion contains large thrombus\n11. Target lesion is heavily calcified\n12. Target lesion is a chronic total occlusion (or subtotal) without adequate lesion preparation.\\* Total and subtotal occlusions may be enrolled assuming they can be crossed with a wire and demonstrate TIMI grade 3 flow at the time of randomization.\n13. Diffuse distal disease to target lesion with impaired runoff","110 Years",{"count":180,"type":21},492,[68],"A Prospective, Multicenter, Randomized, Two-Arm, Single-blind Superiority Trial to Evaluate the Safety and Efficacy of the MagicTouch™ Sirolimus- Coated Balloon in the Treatment of Coronary Drug-Eluting Stent In-Stent Restenosis.\n\nSubjects with prior DES implantation presenting with ISR lesions undergoing PCI will be randomized into two groups: treatment with the MagicTouch™ sirolimus-coated balloon or POBA on a 2:1 basis. Approximately 492 subjects will be enrolled in the randomized study in a maximum of 50 study sites located in the United States.\n\nThe goal is to establish the safety and efficacy of the MagicTouch™ sirolimus- coated balloon in treatment of coronary in-stent restenosis (ISR).",[184,105,103],"In-Stent Restenosis",[107,108,186,110,111,112,176],"ISR","2025-02-24",{"date":189,"type":49},"2025-02-25",{"date":191,"type":49},"2024-04-16",{"date":193,"type":21},"2028-07",{"name":55,"class":56},28,""]