[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stenosis-coronary\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stenosis-coronary":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"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":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100630702","brazilian-prospective-registry-of-the-inspiron-evo-drug-eluting-stent-in-complex-coronary-lesions-100630702",false,"NCT07491107","Brazilian Prospective Registry of the Inspiron EVO Drug-Eluting Stent in Complex Coronary Lesions","National Prospective Registry of the Inspiron EVO Drug-Eluting Stent in Complex Coronary Lesions","PCI EVOlution","Inclusion Criteria:\n\n* Individuals aged 18 years or older presenting with complex coronary lesions requiring percutaneous coronary intervention (PCI).\n* Individuals who provide consent and are willing to comply with the follow-up protocol.\n* Individuals who received treatment with the Inspiron™ EVO Stent.\n* Individuals with lesions ≥ 30 mm in length (Subprotocol 1).\n* Individuals with significantly calcified coronary lesions (moderate to severe according to the ACC\u002FAHA classification B1, B2, or C), with or without indication for lesion preparation techniques (Subprotocol 2).\n* Individuals with multivessel coronary artery disease (≥2 affected coronary vessels, with at least one vessel of small diameter ≤2.5 mm) (Subprotocol 3).\n* Individuals included in Subprotocol 1, 2, or 3. The evaluated segment must be accessible to the IVUS (Intravascular Ultrasound) catheter (Subprotocol 4).\n\nExclusion Criteria:\n\n* Lesions in saphenous vein grafts or internal mammary grafts.\n* Contraindication to the use of a drug-eluting stent.\n* Individuals who were treated during the index procedure with any stent other than the Inspiron™ EVO Stent.","ALL","18 Years",{"count":20,"type":21},2000,"ESTIMATED","12 Months","OBSERVATIONAL","The objective is to evaluate the efficacy and safety of the Inspiron™ EVO drug-eluting stent in complex coronary lesions in a real-world population. Patients with symptomatic ischemic heart disease due to lesions in native coronary arteries and restenotic lesions will be treated with the Inspiron™ EVO drug-eluting stent.",[26,27,28,29,30,31],"Coronary Artery Disease (CAD)","Stenosis Coronary","Small Vessel Ischemic Disease","Multivessel Coronary Artery Disease","Calcific Coronary Arteriosclerosis","Complex Coronary Lesions","NOT_YET_RECRUITING","2026-03-24",{"date":35,"type":36},"2026-03-30","ACTUAL",{"date":38,"type":21},"2026-04-30",{"date":40,"type":21},"2030-04-30",{"name":42,"class":43},"Scitech Produtos Medicos SA","INDUSTRY",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":74},"100544800","spago-sirolimus-paclitaxel-angiographic-gain-objective-100544800","NCT06373601","SPAGO: Sirolimus Paclitaxel Angiographic Gain Objective","Selution Sirolimus Coated Balloon (MedAlliance) Versus SeQuent Please Neo Paclitaxel Coated Balloon (Bbraun) for the Treatment of de Novo Coronary Artery Lesions in Medium-small Size Vessels.","SPAGO","Inclusion Criteria:\n\n1. Male or female subjects ≥18 years\n2. Subject with chronic stable angina or stabilized acute coronary syndromes with normal cardiac biomarker values.\n3. The subject has at least one de-novo lesion in a small vessel (\\>2.00 mm and ≤3.00 mm prior to pre-dilatation) with a diameter stenosis between 50% and 99% (prior to pre-dilatation). It is possible to enroll subjects that have a stent previously implanted in the same epicardial territory (main vessel and ramifications) of the target lesion\n4. Patients with target lesion to be treated with DCB \\\u003C 30 mm in length (up to 40 patients) or with DCB ≥ 30 mm in length (at least 100 patients)\n5. Able to understand and provide informed consent and comply with all study procedures including 12 months angiographic follow-up\n6. Subject must have completed the follow-up phase of any previous study\n\nExclusion Criteria:\n\n1. Subject is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential)\n2. Evidence of ongoing acute myocardial infarction (AMI) in ECG and\u002For elevated cardiac biomarkers (according to local standard hospital practice) have not returned within normal limits at the time of procedure\n3. Known contraindication or hypersensitivity to sirolimus, paclitaxel, or to medications such as aspirin, heparin, and all of the following four medications: clopidogrel bisulfate, ticlopidine, prasugrel, ticagrelor\n4. Subjects who experienced a previous PCI with DCB in the epicardial territory (main vessel and ramifications) where the target lesion is located, during the last 12 months\n5. Subject suffered from stroke\u002FTIA during the last 6 months\n6. LVEF \\\u003C30%\n7. Platelet count \\\u003C100,000 cells\u002Fmm3 or \\>400,000 cells\u002Fmm3, a WBC of \\\u003C3,000 cells\u002Fmm3, or documented or suspected liver disease (including laboratory evidence of hepatitis)\n8. Known renal insufficiency (e.g. serum creatinine \\>2,5 mg\u002FdL, creatinine clearance ≤30 mL\u002Fmin or eGFR ≤30 mL\u002Fmin\u002Fm2), or subject on dialysis, or acute kidney failure (as per physician judgment)\n9. Subject undergoing planned surgery within 1 month with the necessity to stop DAPT\n10. History of bleeding diathesis or coagulopathy\n11. The subject is a recipient of a heart transplant\n12. Concurrent medical condition with a life expectancy of less than 12 months\n13. The subject is unwilling\u002Fnot able to return for angiographic re-catheterisation at 12 months follow-up\n14. Currently participating in another trial\n\n    Angiographic exclusion criteria:\n15. Target vessel size \\>3.00 mm\n16. Target vessel size ≤2.00 mm\n17. Target lesion has a diameter stenosis \\\u003C 50% prior to pre-dilatation\n18. Target lesion has a total occlusion or TIMI flow \\\u003C 2 prior to pre-dilatation\n19. Pre-dilatation of the target lesion not performed or not successful (residual stenosis \\> 30%, TIMI flow \\\u003C 3 and presence of major angiographic dissections)\n20. Target lesion in left main stem\n21. The target vessel contains visible thrombus\n22. Aorto-ostial target lesion (within 3 mm of the aorta junction)\n23. Lesion is located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft",{"count":54,"type":21},140,"INTERVENTIONAL",[57],"NA","The objective of the study is to compare angiographic outcomes of Selution sirolimus coated balloon (MedAlliance) versus SeQuent Please Neo paclitaxel coated balloon (Bbraun) for the treatment of de novo coronary artery lesions in medium size vessels (\\>2.00 mm and ≤3.00 mm) with respect to Net Gain (mm) and Fractional Flow Reserve (FFR) at 12 months follow-up.",[60,27,61,62],"Coronary Artery Disease","Coronary Artery Lesion","Percutaneous Coronary Intervention","RECRUITING","2025-11-25",{"date":66,"type":36},"2025-12-03",{"date":68,"type":36},"2024-09-05",{"date":70,"type":21},"2027-08-01",{"name":72,"class":73},"Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS","OTHER",10]