NCT05471245

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

AnGiographic Performance Following PCI With A Sirolimus-elutiNG Balloon in the TrEatment of De Novo CoronaRy Artery Disease: GINGER Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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

Detailed 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).

Conditions

• Coronary Restenosis

Interventions

Type	Name	Description
DEVICE	Magic Touch SCB by Concept Medical Inc.	PCI with drug-coated balloon

Timeline

• Start date: 2023-05-23
• Primary completion: 2025-10-08
• Completion: 2025-10-08
• First posted: 2022-07-22
• Last updated: 2025-12-03

Locations

7 sites across 1 country: Italy