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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Masking
NONE
Enrollment
28
TAXUS Petal, paclitaxel eluting stent
Institut Hospitalier Jacques Cartier-ICPS, 6, Avenue du Noyer Lambert
Massy, France
HELIOS Klinikum Siegburg, Ringstrasse 49
Siegburg, Germany
Mercy Angiography Unit, 98 Mountain Road, First Floor
Auckland, Epsom, New Zealand
Auckland City Hospital, Cardiac Investigations Unit, Park Road
Auckland, Grafton, New Zealand
Composite safety endpoint at 30 days post-procedure: • All-cause mortality • Documented myocardial infarction • TVR
Time frame: 30 days
Device Success Technical Success Clinical Procedural Success Device malfunctions Ease-of-Use parameters Clinical endpoints Main branch and side branch angiographic endpoints Main branch and side branch IVUS endpoints
Time frame: Index procedure, 30 days, 6 months and 1 - 5 years
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