NCT03242096 - Treatment of Coronary In-stent Restenosis (ISR) by a Sirolimus Coated or a Paclitaxel Coated Balloon | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

July 21, 2017

Primary Completion Date

August 1, 2020

Study Completion Date

January 31, 2021

Conditions

Coronary Restenosis

Interventions

COMBINATION_PRODUCT

Sirolimus coated balloon

Predilatation of coronary ISR with POBA (balloon-to-stent ratio 1:1) followed by a sirolimus coated balloon (SeQuent®SCB balloon with sirolimus 4.0 μg/mm²)

COMBINATION_PRODUCT

Paclitaxel coated balloon

Predilatation of coronary ISR with POBA (balloon-to-stent ratio 1:1) followed by a paclitaxel coated balloon (SeQuent®Please balloon or SeQuent®Please NEO balloon with paclitaxel 3.0 μg/mm²) (paclitaxel 3.0 μg/mm²)

Trial Locations (5)

4031

Universitätsspital Basel, Basel

55131

Deutsches Zentrum für Herz und Kreislauf, Mainz

66421

Clinical and Experimental Interventional Cardiology, Homburg

01307

Klinik für Innere Medizin und Kardiologie, Dresden

Unknown

Dept. of Internal Medicine II, Ulm