Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00140530
Status:
COMPLETED
Last Update Posted:
2008-01-11
First Post:
2005-08-31
Brief Title:
Nonpolymer- and Polymer-Based Drug-Eluting Stents for Restenosis ISAR-TEST-1
Sponsor:
Deutsches Herzzentrum Muenchen
Organization:
Deutsches Herzzentrum Muenchen
Study Overview
Official Title:
A Randomized Trial of a Nonpolymer-Based Rapamycin-Eluting Stent Versus a Polymer-Based Paclitaxel-Eluting Stent for the Prevention of Restenosis ISAR-TEST-1
Status:
COMPLETED
Status Verified Date:
2008-01
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 assess the efficacy of nonpolymer-based rapamycin-eluting stent compared to standard polymer-based paclitaxel-eluting stent to reduce reblockage of coronary arteries
Detailed Description:
Drug-eluting stents represent a major advance in the treatment of restenosis They have dramatically reduced the need of repeat revascularization procedures and thanks to the excellent results obtained in various patient subsets these devices are now used in almost 90 of the stent implantation procedures performed in US hospitals Along with the increasing number of patients receiving drug-eluting stents and availability of long-term follow-up data concern has arisen regarding the safety of these devices At the core of this concern is the potential for increased inflammatory and thrombogenic responses and their life-threatening consequences associated with the polymers employed for the delivery of antirestenotic agents A growing interest has been shown on polymer-free stents with a microporous surface as an alternative to stents employing polymeric coating for local drug delivery Recently we developed a mobile system which enables coating in the catheterization laboratory of polymeric free stents with different drug doses or combinations Using a porcine coronary model of restenosis we found that coating with rapamycin of a polymer-free microporous stent is feasible and effectively reduces neointimal proliferation More recently in a clinical study in which the efficacy of several doses of rapamycin was assessed we showed that non-polymer coating with rapamycin is safe and leads to a dose-dependent reduction in restenosis While the advantage deriving from the lack of polymeric cover in on-site coated rapamycin-eluting stents is readily understandable their relative efficacy as compared with commercially available polymer-based drug-eluting stents has yet to be evaluated
Comparison
Polymer-free microporous stents coated with rapamycin versus standard polymer-based paclitaxel-eluting stents
Comparison
Polymer-free microporous stents coated with rapamycin versus standard polymer-based paclitaxel-eluting stents
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AZ 50402 | None | None | None |