Safety and Efficacy Study of the DANUBIO Paclitaxel Eluting Balloon in In-Stent Restenosis Lesions (DEBREST) (DEBREST)
|In-stent Coronary Artery Restenosis||Device: Danubio paclitaxel-eluting balloon|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Assessment of the Safety and Efficacy of the Danubio Paclitaxel-Eluting Balloon for the Treatment of In-Stent Restenosis Lesions in Native Coronary Arteries.|
- In-stent Late Lumen Loss (mm) [ Time Frame: 6 months post-procedure (up to 26 weeks) ]In-stent Late Lumen Loss by Quantitative Coronary Angiography (QCA)
- In-segment Late Lumen Loss (mm) [ Time Frame: 6 months post-procedure (up to 26 weeks) ]In-segment Late Lumen Loss by QCA.
- Angiographic binary restenosis rate (%) [ Time Frame: 6 months post-procedure (up to 26 weeks) ]Angiographic binary restenosis rate (%) by QCA.
- Major Adverse Cardiac Event (MACE) rate [ Time Frame: In-hospital, 1, 6 and 12 months post-procedure. ]MACE defined as death, Myocardial Infarction (MI, Q waves and non-Q waves), emergent cardiac bypass surgery, or any target lesion revascularization (repeat Percutaneous transluminal coronary angioplasty (PTCA) or Coronary artery bypass grafting (CABG)).
- Clinically-driven Target Lesion Revascularization (TLR) [ Time Frame: 1, 6 and 12 months post-procedure ]
- Target Vessel Failure (TVF) [ Time Frame: 1, 6 and 12 months post-procedure ]
- Target Vessel Revascularization (TVR) [ Time Frame: 1, 6 and 12 months post-procedure ]
- Angiographic success [ Time Frame: Day 1 ]
|Study Start Date:||March 2012|
|Study Completion Date:||July 2014|
|Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
Device: Danubio paclitaxel-eluting balloon
Inflation of the Danubio Paclitaxel Eluting Balloon in in-stent restenosis lesions.
The DEBREST clinical trial is a prospective, non-randomized, multicenter, interventional study evaluating the investigational Danubio Paclitaxel Eluting Coronary Balloon in patients with in-stent restenosis (ISR) lesion(s) with reference vessel diameter ≥2.5 mm and ≤3.5 mm. The trial will allow the treatment of up to two ISR (either Bare Metal Stent (BMS) or Drug Eluting Stent (DES) ISR) per patient in native coronary arteries with mandatory predilatation with a conventional balloon.
The DEBREST clinical trial will enroll 60 patients. All patients will receive Quantitative Coronary Angiography (QCA) before and after Drug-Eluting Balloon (DEB) inflation and at 6 months follow-up. All patients will have a clinical follow-up at 1, 6 and 12 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01485068
|Hôpital Privé d'Antony|
|Antony, France, 92160|
|Centre Hospitalier privé Saint-Martin|
|Caen, France, 14050|
|Centre cardiologique d'Evecquemont|
|Evecquemont, France, 78740|
|Centre Hospitalier d'Haguenau|
|Haguenau, France, 67504|
|Nîmes, France, 30000|
|Polyclinique les Fleurs|
|Ollioules, France, 83192|
|Perpignan, France, 66012|
|Pessac, France, 33600|
|Principal Investigator:||Jacques BERLAND, MD||Clinique Saint Hilaire - ROUEN|