Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-01-03 @ 11:57 PM
Study NCT ID:
NCT00497367
Status:
COMPLETED
Last Update Posted:
2015-03-26
First Post:
2007-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Study to Assess the Feasibility of Use in Humans of the TAXUS Petal Bifurcation Coronary Stent System
Sponsor:
Boston Scientific Corporation
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| S2030-FHU-2007 | None | None | View |