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

Phase 1

Completed

• Conditions: Cardiovascular Diseases
• Interventions: Device: Percutaneous Coronary Intervention (PCI) TAXUS Petal

• Registration Number: NCT00497367
• Lead Sponsor: Boston Scientific Corporation

Brief 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.

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-07-04
• Study First Submitted QC: 2007-07-05
• Study First Posted: 2007-07-06
• Primary Completion: 2008-07
• Study Completion: 2013-06
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-25
• Last Update Posted: 2015-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TAXUS® Petal™ Paclitaxel-Eluting Coronary Stent	Percutaneous Coronary Intervention (PCI) TAXUS Petal	This arm received the TAXUS® Petal™ Paclitaxel-Eluting Coronary Stent.

Primary Outcome Measures

Name	Time	Method
Composite safety endpoint at 30 days post-procedure: • All-cause mortality • Documented myocardial infarction • TVR	30 days

Secondary Outcome Measures

Name	Time	Method
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	Index procedure, 30 days, 6 months and 1 - 5 years

Trial Locations

Locations (4)

Institut Hospitalier Jacques Cartier-ICPS, 6, Avenue du Noyer Lambert; 🇫🇷 Massy, France

Mercy Angiography Unit, 98 Mountain Road, First Floor; 🇳🇿 Auckland, Epsom, New Zealand

HELIOS Klinikum Siegburg, Ringstrasse 49; 🇩🇪 Siegburg, Germany

Auckland City Hospital, Cardiac Investigations Unit, Park Road; 🇳🇿 Auckland, Grafton, New Zealand