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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
52
Inflation of the Danubio Paclitaxel Eluting Balloon in the side branch of a de novo bifurcation lesion.
CHU Clermont-Ferrand
Clermont-Ferrand, France
Pôle Santé République
Clermont-Ferrand, France
Centre Cardiologique d'Evecquemont
Évecquemont, France
Institut hospitalier Jacques Cartier
Massy, France
Late Lumen Loss (mm) in Side Branche (SB)
Late Lumen Loss at the ostium of the SB (within 5mm from the carina) by Quantitative Coronary Angiography (QCA).
Time frame: 6 months post-procedure (up to 26 weeks)
In-stent Late Lumen Loss (mm) in Main Branch (MB)
In-stent Late Lumen Loss in the MB by QCA.
Time frame: 6 months post-procedure (up to 26 weeks)
Angiographic Binary Restenosis rate (%)
Angiographic binary restenosis rate (%) in the side and main branches by QCA.
Time frame: 6 months post-procedure (up to 26 weeks)
Major Adverse Cardiac Event (MACE) rate
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)).
Time frame: In-hospital, 1, 6 and 12 months post-procedure.
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
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CHU Nantes
Nantes, France
Clinique Saint-Hilaire
Rouen, France
Clinique Pasteur
Toulouse, France