NCT00497367

Safety Study to Assess the Feasibility of Use in Humans of the TAXUS Petal Bifurcation Coronary Stent System

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Cardiovascular Diseases

Interventions

Type	Name	Description
DEVICE	Percutaneous Coronary Intervention (PCI) TAXUS Petal	TAXUS Petal, paclitaxel eluting stent

Timeline

• Start date: 2007-07-01
• Primary completion: 2008-07-01
• Completion: 2013-06-01
• First posted: 2007-07-06
• Last updated: 2015-03-26

Locations

4 sites across 3 countries: France, Germany, New Zealand