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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2005-06-30

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Coronary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Due to randomisation patients got a Paclitaxel-eluting stent

Group Type EXPERIMENTAL

Paclitaxel-eluting stent (Taxus)

Intervention Type DEVICE

patients has been implanted the Paclitaxel-eluting stent.

2

Due to randomization patients got a Rapamycin-eluting stent.

Group Type EXPERIMENTAL

Rapamycin-eluting stent

Intervention Type DEVICE

patients has been implanted the Rapamycin-eluting stent.

Interventions

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Paclitaxel-eluting stent (Taxus)

patients has been implanted the Paclitaxel-eluting stent.

Intervention Type DEVICE

Rapamycin-eluting stent

patients has been implanted the Rapamycin-eluting stent.

Intervention Type DEVICE

Other Intervention Names

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Taxus

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No