Nonpolymer- and Polymer-Based Drug-Eluting Stents for Restenosis (ISAR-TEST-1)

Phase 4

Completed

• Conditions: Coronary Disease
• Interventions: Device: Paclitaxel-eluting stent (Taxus); Device: Rapamycin-eluting stent

• Registration Number: NCT00140530
• Lead Sponsor: Deutsches Herzzentrum Muenchen

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

Study Timeline

• Study Start: 2004-03
• Study Completion: 2005-06
• Study First Submitted: 2005-08-31
• Study First Submitted QC: 2005-08-31
• Study First Posted: 2005-09-01
• Status Verified: 2008-01
• Last Update Submitted: 2008-01-10
• Last Update Posted: 2008-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

• Patients at least 18 years old
• Stable or unstable angina or a positive stress test
• "de novo" coronary artery lesions
• Written informed consent

Exclusion Criteria

• Myocardial infarction within 48 h. before enrollment
• Target lesion located in left main trunk
• Contraindication or known allergy to aspirin, heparin, thienopyridines, rapamycin, paclitaxel or stainless steel

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Paclitaxel-eluting stent (Taxus)	Due to randomisation patients got a Paclitaxel-eluting stent
2	Rapamycin-eluting stent	Due to randomization patients got a Rapamycin-eluting stent.

Primary Outcome Measures

Name	Time	Method
In-stent late luminal loss	6 months

Secondary Outcome Measures

Name	Time	Method
Angiographic restenosis at follow-up angiography	6 months
Need for target lesion revascularization due restenosis at 9 months	9 months

Trial Locations

Locations (2)

First Medizinische Klinik, Klinikum rechts der Isar; 🇩🇪 Munich, Germany

Deutsches Herzzentrum Muenchen; 🇩🇪 Munich, Germany