Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00380809
Status:
COMPLETED
Last Update Posted:
2019-07-26
First Post:
2006-09-25
Brief Title:
Rotational Atherectomy Prior to Taxus Stent
Sponsor:
Segeberger Kliniken GmbH
Organization:
Segeberger Kliniken GmbH
Study Overview
Official Title:
Rotational Atherectomy Prior to Taxus Stent Treatment for Complex Native Coronary Artery Disease A Multicenter Prospective Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2019-07
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 primary purpose of this study is to evaluate the long term effects of the polymer-based slow-release paclitaxel-eluting stent TAXUS Boston Scientific with or without prior rotablation in an angiographically well defined group of patients with complex calcified coronary lesions
Detailed Description:
Calcification is an essential part of all atherosclerotic plaques Its extent increases with the progression of atherosclerotic disease Heavily calcified lesions form a particular threat to DES both damage to the polymer coating during vigorous advancement and inadequate diffusion of the drug to the subintima through extensive calcium arcs could contribute to the ineffectiveness of DES when implanted into such lesions or may lead to primary stent delivery or expansion failure Rotational atherectomy can effectively ablate calcified plaques In the DES era data concerning rotational atherectomy are scarce DES implantation following rotablation seems a rational combination but is only poorly supported by controlled studies In the present study we are using the polymer-based slow-release paclitaxel-eluting stent TAXUS Boston Scientific with or without prior rotablation in an angiographically well defined group of patients with complex calcified coronary lesions This prospective randomized controlled study aims at evaluating the long term effects of both strategies in this complex cohort of patients
Study Oversight
Has Oversight DMC:
None
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?:
None