Coronary Disease Clinical Trial
Official title:
Assessment of the Safety and Efficacy of the Nile PAX® Drug Eluting Coronary Bifurcation Stent System for the Treatment of Single de Novo Bifurcation Lesions in Native Coronary Arteries
The purpose of this trial is to assess the safety and efficacy of the Nile PAX® Drug Eluting Coronary Bifurcation Stent System for the treatment of single de novo bifurcation lesions in native coronary arteries with a main branch reference vessel diameter of 2.5-3.5 mm and side branch reference vessel diameter of 2.0-3.0 mm.
The BIPAX clinical trial is a prospective, non-randomized, multicenter, clinical trial
evaluating the investigational coronary bifurcation device Nile PAX® in patients with main
branch reference vessel diameters >= 2.5 mm and <= 3.5 mm, side branch reference vessel
diameters >= 2.0 and <= 3.0 and lesion length <= 14 mm. The trial allows the treatment of a
single de novo bifurcation lesion in native coronary arteries following the provisional
T-stenting technique with mandatory pre-dilatation of the main branch. In case the side
branch requires a stent the treatment will be completed when possible with a Delta PAX® Drug
Eluting Side Branch Stent.
The BIPAX clinical trial will enroll 100 patients. All patients will receive Quantitative
Coronary Angiography (QCA) after stent implantation and at 9 months follow-up. All patients
will have a clinical follow-up at 1, 6, 9 and 12 months and subsequently every year up to 5
years.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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