Coronary Restenosis Clinical Trial
Official title:
AnGiographic Performance Following PCI With A Sirolimus-elutiNG Balloon in the TrEatment of De Novo CoronaRy Artery Disease: GINGER Study
Evaluate angiographic performance in long lesions of Sirolimus Eluting Balloon Magic Touch by Concept Medical
To assess the angiographic performance of the Magic Touch Sirolimus-Coated Balloon (SCB) at 9 months follow-up after PCI for de novo CAD. Primary end-points: - Late lumen loss (LLL) at the SCB-treated segment within 9 months after the index procedure; - Mean net lumen diameter gain at the SCB-treated segment at 9 months angiographic follow-up. Secondary end-points: - Procedural success defined as both SCB delivery and inflation at the "target" lesion site with <30% diameter stenosis (DS) in the SCB-treated segment and distal Thrombolysis In Myocardial Infarction (TIMI) 3 flow; - Peri-procedural myocardial infarction (PMI) defined according to the EXCEL trial (creatinine kinase myocardial band) or Society for Cardiovascular Angiography and Interventions definitions (troponin); - Binary restenosis rate at the SCB-treated segment at 9 months angiographic follow-up; - A Device Oriented Composite End-point (DOCE) and its singular components (cardiac death, any target-vessel myocardial infarction excluding PMI, ischemia-driven target lesion revascularization) in-hospital, within 7 days after PCI; phone follow-up at 30-day (+/- 7 days) and 12 months (+/- 1 month) and a follow-up visit at 9 months (+/- 1 month). Any definite/probable SCB-treated segment thrombosis (in-hospital, within 7 days after PCI and at 30-day, 9-month, 1-year follow-up). ;
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