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AnGiographic Performance With A Sirolimus-elutiNG Balloon in the TrEatment of De Novo CoronaRy Artery Disease — GINGER  

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

Clinical Trial Summary

Evaluate angiographic performance in long lesions of Sirolimus Eluting Balloon Magic Touch by Concept Medical

Clinical Trial Description

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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05471245
Study type Interventional
Source Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS
Contact Alfonso Ielasi, MD
Phone 00393388433189
Email alfonso.ielasi@gmail.com
Status Recruiting
Phase N/A
Start date May 23, 2023
Completion date August 31, 2025
View Details
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