Safety and Efficacy Study of the DANUBIO Paclitaxel Eluting Balloon in Side Branches of de Novo Bifurcation Lesions (DEBSIDE)
The purpose of this study is to assess the safety and efficacy of the Danubio Paclitaxel Eluting Balloon for the treatment of side branches of de novo bifurcation lesions in native coronary arteries.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
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 Side Branches of de Novo Bifurcation Lesions in Native Coronary Arteries.|
- Late Lumen Loss (mm) in Side Branche (SB) [ Time Frame: 6 months post-procedure (up to 26 weeks) ] [ Designated as safety issue: No ]Late Lumen Loss at the ostium of the SB (within 5mm from the carina) by Quantitative Coronary Angiography (QCA).
- In-stent Late Lumen Loss (mm) in Main Branch (MB) [ Time Frame: 6 months post-procedure (up to 26 weeks) ] [ Designated as safety issue: No ]In-stent Late Lumen Loss in the MB by QCA.
- Angiographic Binary Restenosis rate (%) [ Time Frame: 6 months post-procedure (up to 26 weeks) ] [ Designated as safety issue: No ]Angiographic binary restenosis rate (%) in the side and main branches by QCA.
- Major Adverse Cardiac Event (MACE) rate [ Time Frame: In-hospital, 1, 6 and 12 months post-procedure. ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]
- Target Vessel Failure (TVF) [ Time Frame: 1, 6 and 12 months post-procedure ] [ Designated as safety issue: Yes ]
- Target Vessel Revascularization (TVR) [ Time Frame: 1, 6 and 12 months post-procedure ] [ Designated as safety issue: Yes ]
- Angiographic success [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
|Study Start Date:||May 2012|
|Estimated 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 the side branch of a de novo bifurcation lesion.
The DEBSIDE clinical trial is a prospective, non-randomized, multicenter, interventional study evaluating the investigational Danubio Paclitaxel Eluting Coronary Balloon for the treatment of Side Branches (SB) of de novo bifurcation lesions with a side branch reference vessel diameter ≥2.0 mm and ≤3.0 mm. During the procedure, a dedicated drug-eluting bifurcated stent will be implanted in the main branch. The trial will allow the treatment of lesion of all Medina type except (0,0,1) in native coronary arteries with sequential predilatation of the main and side branch.
The DEBSIDE 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.
|Pôle Santé République|
|Clermont Ferrand, France, 63050|
|Clermont-Ferrand, France, 63003|
|Centre Cardiologique d'Evecquemont|
|Evecquemont, France, 78740|
|Institut hospitalier Jacques Cartier|
|Massy, France, 91300|
|Nantes, France, 44093|
|Rouen, France, 76000|
|Toulouse, France, 31076|
|Principal Investigator:||Jacques BERLAND, MD||Clinique Saint Hilaire - ROUEN|