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

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ClinicalTrials.gov Identifier: NCT00140530
Recruitment Status : Completed
First Posted : September 1, 2005
Last Update Posted : January 11, 2008
Sponsor:
Collaborator:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Coronary Disease Device: Paclitaxel-eluting stent (Taxus) Device: Rapamycin-eluting stent Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : March 2004
Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Due to randomisation patients got a Paclitaxel-eluting stent
Device: Paclitaxel-eluting stent (Taxus)
patients has been implanted the Paclitaxel-eluting stent.
Other Name: Taxus
Experimental: 2
Due to randomization patients got a Rapamycin-eluting stent.
Device: Rapamycin-eluting stent
patients has been implanted the Rapamycin-eluting stent.


Outcome Measures

Primary Outcome Measures :
  1. In-stent late luminal loss [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Angiographic restenosis at follow-up angiography [ Time Frame: 6 months ]
  2. Need for target lesion revascularization due restenosis at 9 months [ Time Frame: 9 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00140530


Locations
Germany
Deutsches Herzzentrum Muenchen
Munich, Germany, 80636
First Medizinische Klinik, Klinikum rechts der Isar
Munich, Germany, 81675
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
Bayerische Forschungsstiftung Muenchen
Investigators
Study Chair: Albert Schomig, MD Deutsches Herzzentrum Muenchen
Principal Investigator: Adnan Kastrati, MD Deutsches Herzzentrum Muenchen
More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00140530     History of Changes
Other Study ID Numbers: GE IDE No. S02103
AZ 504/02
First Posted: September 1, 2005    Key Record Dates
Last Update Posted: January 11, 2008
Last Verified: January 2008

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Sirolimus
Everolimus
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs