Cardiovascular Diseases Clinical Trial
Official title:
A Prospective, Single-arm, Multicenter 2-phase Feasibility Study to Assess the TAXUS Petal Paclitaxel-Eluting Bifurcation Coronary Stent System (TAXUS Petal)for the Treatment of de Novo Atherosclerotic Bifurcation Lesions
The purpose of this study is to determine the safety and feasibility of use in humans of the TAXUS Petal Paclitaxel-Eluting Bifurcation Coronary Stent System in the treatment of de novo lesions in native coronary arteries involving a major side branch. The TAXUS® Petal™ is an investigational device with an indication of improving coronary artery luminal diameter while maintaining side branch access in subjects with symptomatic ischemic disease due to discrete atherosclerotic bifurcation lesions
To assess the safety and feasibility of use in humans of the TAXUS Petal Paclitaxel-Eluting
Bifurcation Coronary Stent System (TAXUS® Petal™) for the treatment of de novo
atherosclerotic bifurcation lesions (by visual estimate):
- Phase 1:
- Main branch: 3.0 to 3.5 mm RVD and lesion length ≤20 mm
- Side branch: 2.5 to 3.5 mm RVD and lesion length ≤14 mm
- Phase 2:
- Main branch: 3.0 to 3.5 mm RVD and lesion length ≤28 mm
- Side branch: 2.25 to 3.5 mm RVD and lesion length ≤14 mm
Bifurcation main branch (MB) lesion length will be measured from the proximal shoulder of
the most proximal lesion to the distal shoulder of the most distal lesion. Bifurcation side
branch (SB) lesion length will be measured from the proximal shoulder of the side branch (if
the ostium is disease-free) or the side branch ostium (if the disease continues into the
main branch) to the distal side branch shoulder of the most distal lesion. At follow-up, the
entire stented region will be used to determine MLD and %DS.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
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