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

This study has been completed.
Sponsor:
Collaborator:
Bayerische Forschungsstiftung Muenchen
Information provided by:
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT00140530
First received: August 31, 2005
Last updated: January 10, 2008
Last verified: January 2008

August 31, 2005
January 10, 2008
March 2004
Not Provided
In-stent late luminal loss [ Time Frame: 6 months ]
In-stent late luminal loss
Complete list of historical versions of study NCT00140530 on ClinicalTrials.gov Archive Site
  • Angiographic restenosis at follow-up angiography [ Time Frame: 6 months ]
  • Need for target lesion revascularization due restenosis at 9 months [ Time Frame: 9 months ]
  • Angiographic restenosis at follow-up angiography
  • Need for target lesion revascularization due restenosis at 9 months
Not Provided
Not Provided
 
Nonpolymer- and Polymer-Based Drug-Eluting Stents for Restenosis (ISAR-TEST-1)
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)

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.

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

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Coronary Disease
  • Device: Paclitaxel-eluting stent (Taxus)
    patients has been implanted the Paclitaxel-eluting stent.
    Other Name: Taxus
  • Device: Rapamycin-eluting stent
    patients has been implanted the Rapamycin-eluting stent.
  • Experimental: 1
    Due to randomisation patients got a Paclitaxel-eluting stent
    Intervention: Device: Paclitaxel-eluting stent (Taxus)
  • Experimental: 2
    Due to randomization patients got a Rapamycin-eluting stent.
    Intervention: Device: Rapamycin-eluting stent

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
450
June 2005
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00140530
GE IDE No. S02103, AZ 504/02
Yes
Not Provided
Deutsches Herzzentrum Muenchen
Bayerische Forschungsstiftung Muenchen
Study Chair: Albert Schomig, MD Deutsches Herzzentrum Muenchen
Principal Investigator: Adnan Kastrati, MD Deutsches Herzzentrum Muenchen
Deutsches Herzzentrum Muenchen
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP