[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"in-stent-restenosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:in-stent-restenosis":197},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,41,72,97,123,150,183,216],{"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":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100642512","opn-balloon-for-safe-recanalization-of-calcified-coronary-lesions-100642512",false,"NCT07646444","OPN Balloon for SAFE Recanalization of Calcified Coronary Lesions","OPN Balloon for SAFE Recanalization of Calcified Coronary Lesions (OPEN-SAFE Registry)","OPEN-SAFE","Inclusion Criteria:\n\n* Age 18 years or older\n* Subjects who underwent a clinically indicated PCI procedure that involved at least one OPN balloon\n* Date range for data collection will be from February 1, 2023 to December 31, 2028\n\nExclusion Criteria:\n\n* Subjects who have opted out of being included in research related data collection","ALL","18 Years",{"count":20,"type":21},300,"ESTIMATED","1 Week","OBSERVATIONAL","The goal of the OPEN-SAFE registry is to describe the contemporary use and outcomes of SIS-OPN in North America.",[26,27,28],"Coronary Arterial Disease (CAD)","In Stent Restenosis","Calcified Coronary Lesions","NOT_YET_RECRUITING","2026-06-10",{"date":32,"type":33},"2026-06-12","ACTUAL",{"date":35,"type":21},"2026-06",{"date":37,"type":21},"2027-06",{"name":39,"class":40},"Minneapolis Heart Institute Foundation","OTHER",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100606480","functional-milk-supplementation-to-reduce-in-stent-restenosis-in-stemi-patients-smasoea-trial-100606480","NCT07176104","Functional Milk Supplementation to Reduce In-Stent Restenosis in STEMI Patients (SMASOEA Trial)","Effects of Functional Bovine Milk Supplementation on Coronary In-Stent Restenosis and Major Adverse Cardiovascular Events in STEMI Patients Undergoing Primary PCI: A Randomized, Double-Blind, Controlled Trial","SMASOEA","Inclusion Criteria:\n\n* Age 18-80 years\n* First ST-elevation myocardial infarction (STEMI) treated with percutaneous coronary intervention (PCI) and drug-eluting stent implantation within the previous 4 weeks\n* Stable clinical condition at enrollment\n* Willingness to adhere to study procedures and dietary supplementation for 12 months\n* Signed informed consent\n\nExclusion Criteria:\n\n* Previous myocardial infarction or coronary revascularization\n* Cardiogenic shock or severe heart failure (NYHA class IV)\n* Severe renal impairment (eGFR \\\u003C30 mL\u002Fmin\u002F1.73m²) or dialysis\n* Active malignancy or life expectancy \\\u003C1 year\n* Known lactose intolerance or allergy to milk proteins\n* Participation in another interventional clinical trial in the last 30 days","80 Years",{"count":51,"type":21},140,"INTERVENTIONAL",[54],"NA","This randomized, double-blind, controlled clinical trial will evaluate the effects of daily supplementation with functionalized bovine milk, enriched with bioactive peptides and optimized lipid profile, on coronary in-stent restenosis and major adverse cardiovascular events (MACE) in patients with first ST-elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PCI) and drug-eluting stent (DES) implantation. Participants will be randomly assigned to receive either functionalized milk or an isocaloric non-functional milk for 12 months, in addition to standard secondary prevention care. The primary endpoint is the incidence of in-stent restenosis at 12 months, assessed by coronary computed tomography angiography (CCTA). Secondary endpoints include MACE occurrence, metabolic and inflammatory biomarkers, oxidative stress markers, serum sirtuins, metabolomic profiles, and myocardial injury evaluated by cardiac positron emission tomography (PET). The study aims to determine whether functionalized milk can improve cardiovascular outcomes and modulate pathophysiological mechanisms after STEMI.",[57,58],"ST-elevation Myocardial Infarction (STEMI)","In-stent Restenosis",[60,61],"ST-Elevation Myocardial Infarction","Inflammation","2026-05-05",{"date":64,"type":33},"2026-05-06",{"date":66,"type":21},"2026-07",{"date":68,"type":21},"2027-08",{"name":70,"class":40},"Raffaele Marfella",1,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":17,"minAge":79,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":82,"conditions":83,"keywords":84,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":71},"100622325","target-vessel-failure-after-laser-assisted-percutaneous-angioplasty-versus-balloon-based-treatment-for-drug-eluting-in-stent-restenosis-100622325","NCT07382154","Target Vessel Failure After Laser Assisted Percutaneous Angioplasty Versus Balloon-based Treatment for Drug Eluting In-stent Restenosis","SONIC","Inclusion Criteria:\n\n* Patients aged ≥ 18 years who have undergone coronary angioplasty for restenosis of a drug-eluting stent in at least one coronary vessel\n* Acquisition of written informed consent from patients included in the study\n* 1-year follow-up in patients in the retrospective cohort\n\nExclusion Criteria:\n\n* concurrent presence of a new angiographically significant lesion on the coronary artery treated for ISR\n* hybrid treatment of two or more drug-eluting stent restenoses in the same angioplasty procedure. That is, treatment of one or more restenoses with balloon-based therapy alone and treatment of one or more restenoses using the ELCA technique in the same angioplasty procedure.\n* inability to take dual antiplatelet therapy for the period required by the coronary angioplasty procedure 4) life expectancy \\\u003C 1 year","19 Years",{"count":81,"type":21},1260,"Stent restenosis (ISR) is an increasingly common problem; in fact, approximately 10% of coronary angioplasty procedures involve the treatment of a previously implanted stent. In cases of ISR of drug-eluting stents, the rate of further restenosis remains high (approximately 13% at one year). The treatment of stent restenosis consists of the use of balloon-based methods. Some small, single-center observational studies suggest the effectiveness of Excimer Laser Coronary Atherectomy (ELCA) in this context, allowing for a wider coronary lumen, a better minimum stent area (MSA), and a numerically lower incidence of new stent restenosis.\n\nDemonstrating that Excimer Laser Coronary Atherectomy (ELCA)-assisted angioplasty treatment for DES ISR is associated with a lower incidence of Target Vessel Failure at 1 year compared to balloon-based angioplasty techniques may allow for better treatment of this type of patient.",[58],[85,86,87],"in-stent restenosis","drug-eluting stents","Excimer Laser Coronary Atherectomy","2026-01-26",{"date":90,"type":33},"2026-02-02",{"date":92,"type":21},"2026-02",{"date":94,"type":21},"2028-07",{"name":96,"class":40},"IRCCS Azienda Ospedaliero-Universitaria di Bologna",{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":104,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":106,"conditions":107,"keywords":110,"overallStatus":113,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":71},"100615825","intravascular-imaging-guided-versus-angiography--guided-pci-in-patients-with-des-isr-100615825","NCT07297641","Intravascular Imaging-Guided Versus Angiography- Guided PCI in Patients With DES-ISR","Intravascular Imaging-Guided Versus Angiography- Guided Percutaneous Coronary Intervention for Drug-eluting In-stent Restenosis","Inclusion Criteria:\n\n(1) Patients with DES-ISR lesions; (2) Life expectancy of at least 1 year; (3) DES-ISR lesions occurring for the first time in native coronary arteries and suitable for re-PCI based on angiographic findings.\n\nExclusion Criteria:\n\n(1) Bare-metal stent in-stent restenosis (BMS-ISR). (2) Non-DES-ISR lesions. (3) Incomplete clinical and angiographic data. (4) Poor quality of IVUS or angiographic images. (5) Recurrent DES-ISR. (6) Optical coherence tomography (OCT) guidance.",{"count":105,"type":21},1500,"This study aimed to compare the clinical and angiographic outcomes of patients with DES-ISR who underwent repeat PCI with intravascular imaging or angiographic guidance.",[108,58,109],"PCI","Intravascular Imaging Device",[85,111,112],"Intravascular imaging device","percutaneous coronary intervention","RECRUITING","2025-12-09",{"date":116,"type":33},"2025-12-22",{"date":118,"type":21},"2026-01-01",{"date":120,"type":21},"2027-08-01",{"name":122,"class":40},"Nanjing First Hospital, Nanjing Medical University",{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":52,"phases":132,"briefSummary":134,"conditions":135,"keywords":136,"overallStatus":113,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":149},"100523074","phase-4-anti-inflammatory-therapy-for-recurrent-in-stent-restenosis-100523074","NCT06090890","Anti-inflammatory Therapy for Recurrent In-stent Restenosis","Safety and Efficacy of Low Dose Colchicine or Prednisone Combining With Standard Drug in Patients With Recurrent In-stent Restenosis: a Prospective, Randomized, Open-label Trial","Inclusion Criteria:\n\n1. CAD patients over 18 years old;\n2. At least one coronary artery lesion meets the RISR criteria: target lesion ≥ 2 ISRs (stenosis of lumen diameter within the stent segment and within 5mm near and far of the stent ≥ 50%);\n3. Intended intervention treatment for RISR lesions;\n4. Acceptable for standard secondary prevention drug therapy for coronary heart disease, including dual antiplatelet therapy (DAPT) and statins;\n5. Willing to participate in the trial and complete follow-up, signing an informed consent form approved by the ethics committee\n\nExclusion Criteria:\n\n1. The previous interventional treatment situation is unknown;\n2. The mechanism of intracavitary imaging to clarify ISR is operator-related (poor stent adhesion, incomplete dilation, and stent fracture);\n3. Clearly diagnose vascular inflammatory diseases or connective tissue diseases (including arteritis, Behcet's disease, systemic lupus erythematosus, etc.) involving the coronary artery;\n4. Immunosuppressive drugs, including glucocorticoids, have been used in the past 30 days;\n5. There are contraindications to the use of prednisone or colchicine, including: serious infectious diseases, including active infection, hepatitis B, hepatitis C or AIDS patients; Hematological diseases, such as thrombocytopenia, severe anemia, leukemia, etc; Uncontrolled diabetes; Severe liver and kidney function damage; Active peptic ulcer or gastrointestinal bleeding; Severe osteoporosis (with previous pathological fractures); Inflammatory bowel disease or chronic diarrhea;\n6. A history of malignant tumors within 3 years;\n7. Cognitive impairment;\n8. Not willing to participate or follow up",{"count":131,"type":21},252,[133],"PHASE4","This study is aimed at making a comparison of the safety and efficacy of standard drug therapy (control group), standard drugs combined with lose-dose colchicine therapy (colchicine group) and standard drug combined with prednisone therapy (prednisone group) in patients with coronary heart disease who suffered from recurrent In-stent restenosis (RISR).",[58],[137,58,138,139],"Anti-inflammatory therapy","Colchicine","Prednisone","2025-08-05",{"date":142,"type":33},"2025-08-08",{"date":144,"type":33},"2023-10-30",{"date":146,"type":21},"2027-10-29",{"name":148,"class":40},"Fu Wai Hospital, Beijing, China",4,{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":156,"eligibilityCriteria":157,"healthyVolunteers":158,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":159,"targetDuration":4,"studyType":52,"phases":161,"briefSummary":164,"conditions":165,"keywords":168,"overallStatus":113,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":71},"100590549","phase-1-pilot-study-of-the--prototype-nimble-system-feasibility-safety-and-initial-performance-in-non-invasive-detection-of-coronary-in-stent-restenosis-100590549","NCT06968858","Pilot Study of the α Prototype NIMBLE System: Feasibility, Safety, and Initial Performance in Non-Invasive Detection of Coronary In-Stent Restenosis","First-in-human Study to Assess the Clinical Feasibility, Safety, and Performance of the α Prototype of the NIMBLE System for Diagnosing Complications in Intracoronary Stents. NIMBLE-I Study.","NIMBLE-I","Inclusion Criteria:\n\n* Prior implantation of one or more coronary stents\n* Clinical symptoms suggestive of stent failure (e.g., chest pain, ischemic ECG changes)\n* Undergoing scheduled coronary angiography\n* Informed consent provided\n\nExclusion Criteria:\n\n* Pregnancy\n* Implanted electronic devices (e.g., pacemakers) that may interfere with MWI\n* Inability to provide consent\n* Chest conditions preventing correct positioning of the device",true,{"count":160,"type":21},30,[162,163],"PHASE1","PHASE2","The NIMBLE-I study is a prospective, unicentric, single arm, feasibility clinical trial designed to evaluate a novel medical device for the non-invasive monitoring of coronary stents. The study is being conducted at the Hospital Germans Trias i Pujol in Badalona, Spain, under the supervision of Dr. Oriol Rodríguez Leor, an experienced interventional cardiologist. It is sponsored by NIMBLE Diagnostics, a company developing the NIMBLE system-a non-ionizing, non-invasive prototype based on microwave interferometry (MWI).\n\nThe motivation behind the study stems from the clinical challenge of detecting in-stent restenosis (ISR), a common complication following stent implantation that affects up to 10% of patients. Current diagnostic methods typically rely on invasive procedures such as coronary angiography or intravascular imaging, which are resource-intensive and carry procedural risks. The NIMBLE system has the potential to address this need by providing a safe, fast, and non-invasive alternative capable of detecting structural changes around coronary stents.\n\nThe primary objective of the NIMBLE-I study is to assess the technical feasibility of the NIMBLE device in a real-world clinical setting. Secondary objectives include evaluating the safety of the device, generating preliminary data on its effectiveness by comparing its measurements with those obtained from invasive coronary angiography-the reference standard for diagnosing ISR-and collecting usability data to inform improvements in future versions of the device.\n\nThe study is designed to enroll up to 120 patients of whom 30 will undergo an OCT examination to evaluate the ability of the α prototype to measure ISR. Participants must be adults with previously implanted coronary stents who present with symptoms suggestive of ISR-such as chest pain or ischemic changes on an electrocardiogram-and are already scheduled for diagnostic angiography. Patients with contraindications such as pregnancy, implanted electronic devices (like pacemakers), or anatomical limitations that preclude correct device positioning will be excluded.\n\nThe procedure begins with obtaining informed consent from eligible patients. Prior to the scheduled angiographic procedure, the NIMBLE system is used to perform a non-invasive scan. The device, which includes biocompatible transducers, is placed externally over the patient's chest at the level of the coronary stent. Data acquisition does not interfere with standard clinical care. After the NIMBLE scan, patients proceed with their routine coronary angiography as per standard of care. Importantly, operators performing the angiography remain blinded to the results of the NIMBLE device.\n\nData analysis will focus on two main areas. The primary endpoint is the successful completion of NIMBLE measurements without device-related adverse events. Secondary endpoints include the agreement between NIMBLE output-specifically, a calculated metric called %RIS (percent restenosis intrastent)-and angiographic findings. Statistical methods will be applied to assess sensitivity, specificity, correlation, and agreement between modalities. Usability feedback from clinical operators will also be collected to inform future device iterations.\n\nThe study complies with all applicable regulatory and ethical guidelines, including ISO 14155 and the European Medical Device Regulation (MDR 2017\u002F745). It has been approved by the relevant ethics committee and competent authority before its launch. Each patient's data will be anonymized and handled according to Good Clinical Practice (GCP) standards.\n\nExpected outcomes from the NIMBLE-I study include confirmation that the device can be safely and effectively used in a clinical context and that its diagnostic output correlates with invasive imaging findings. Positive results will lay the groundwork for a pivotal clinical trial and advance the development of a tool that could significantly improve the follow-up of patients with coronary stents. Ultimately, this technology could reduce the need for invasive procedures and enable earlier detection of stent-related complications in an outpatient setting.",[58,166,167],"Stent Fracture","Stent Complication",[169,170,171,172,85],"non-invasive","microwave","prototype","nimble","2025-05-05",{"date":175,"type":33},"2025-05-13",{"date":177,"type":33},"2024-09-12",{"date":179,"type":21},"2025-10",{"name":181,"class":182},"Nimble Diagnostics S.L.","INDUSTRY",{"id":184,"slug":185,"hasResults":11,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":189,"eligibilityCriteria":190,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":191,"enrollmentInfo":192,"targetDuration":4,"studyType":52,"phases":194,"briefSummary":195,"conditions":196,"keywords":200,"overallStatus":113,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":213,"locationsCount":215},"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":193,"type":21},492,[54],"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).",[197,198,199],"In-Stent Restenosis","Cardiovascular Diseases","Coronary Artery Disease",[201,202,203,204,205,206,189],"Drug coated balloon","Sirolimus coated balloon","ISR","Magic Touch","SCB","Concept Medical","2025-02-24",{"date":209,"type":33},"2025-02-25",{"date":211,"type":33},"2024-04-16",{"date":94,"type":21},{"name":214,"class":182},"Concept Medical Inc.",28,{"id":217,"slug":218,"hasResults":11,"nctId":219,"briefTitle":220,"officialTitle":220,"acronym":221,"eligibilityCriteria":222,"healthyVolunteers":11,"sex":17,"minAge":79,"maxAge":4,"enrollmentInfo":223,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":225,"conditions":226,"keywords":227,"overallStatus":113,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":71},"100524076","safety-and-efficacy-of-paclitaxel-coated-ptca-balloon-catheter-with-a-shellac-plus-vitamin-e-excipient-genoss-dcb-in-patients-with-coronary-in-stent-restenosis-isr-a-prospective-multi-center-observational-study-100524076","NCT06104007","Safety and Efficacy of Paclitaxel Coated PTCA Balloon Catheter With a Shellac Plus Vitamin E Excipient (GENOSS® DCB) in Patients With Coronary In-stent Restenosis (ISR): A Prospective, Multi-center, Observational Study","SFRGENISTA","Inclusion Criteria:\n\n* Patients with coronary in-stent restenosis (ISR) who underwent percutaneous coronary intervention using the Genoss® DCB.\n* Participants who have agreed to the clinical trial protocol and the clinical follow-up study plan, voluntarily decided to participate in this clinical research, and have provided written consent on the research participant agreement form.\n\nExclusion Criteria:\n\n* Women of childbearing age who plan to become pregnant during the study duration.\n* Patients scheduled for a surgery within 12 months of enrollment that requires discontinuation of antiplatelet agents.\n* Patients for whom the expected remaining life span is less than one year.\n* Patients who presented with cardiogenic shock at the time of their visit and, based on medical assessment, are predicted to have a low likelihood of survival.\n* Patients currently involved in a randomized medical device study.\n* Patients deemed by the researcher to be unsuitable for this study or whose participation might increase associated risks.",{"count":224,"type":21},1000,"The SFRGENISTA study aims to evaluate the long-term efficacy and safety of a paclitaxel-coated balloon catheter containing shellac and vitamin E excipients (Genoss® DCB) in patients with coronary in-stent restenosis (ISR).",[199,58],[199,58,228],"Drug-coated Balloon","2023-10-23",{"date":231,"type":33},"2023-10-27",{"date":233,"type":33},"2023-08-17",{"date":235,"type":21},"2028-12-31",{"name":237,"class":40},"Seoul National University Hospital"]