Rapamycin-Eluting Stents With Different Polymer Coating to Reduce Restenosis (ISAR-TEST-3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00350454
Recruitment Status : Completed
First Posted : July 10, 2006
Last Update Posted : January 11, 2008
Information provided by:
Deutsches Herzzentrum Muenchen

Brief Summary:
The purpose of this study is to evaluate the efficacy of 3 different rapamycin-eluting-stent platforms to reduce coronary artery reblockage after stent implantation

Condition or disease Intervention/treatment Phase
Coronary Heart Disease Device: rapamycin-eluting Stent with permanent polymer Device: rapamycin-eluting stent with biodegradable polymer Device: polymer-free, rapamycin-eluting stent Phase 4

Detailed Description:
Coronary artery reblockage remains still a drawback of percutaneous coronary interventions even in the era of drug-eluting stents (DES). DESs working principle consists of the delivery of controlled amounts of antiproliferative agents at the local level, which results in the suppression of neointimal proliferation, the main cause of lumen re-narrowing after stent implantation. At present, several DES platforms have been developed and evaluated for clinical use. They differ between them with regard to the stent type, anti-proliferative drug, presence of polymers employed for drug storage and modification of drug-release kinetics as well as type of polymer used for this purpose. Although their mid-term efficacy has been well-established, there is an ongoing debate on the potential of an increased incidence of late stent thrombosis, particularly after discontinuation of thienopyridine therapy, as well as of delayed onset of restenosis or catch-up phenomenon with DESs. Based on animal and human pathological data, investigators have linked the above-mentioned concerns to the presence of polymers in DESs, which have a proinflammatory and prothrombinogenic potential, and sometimes may induce a hypersensitivity reaction. This trial will compare the anti-restenotic efficacy of the permanent polymer (PP), biodegradable polymer (BP) and polymer-free (PF) rapamycin-eluting stents in patients with coronary artery disease. Cypher stent (PP) is a stainless steel stent coated with sirolimus with use of permanent polymers while the ISAR stent is a rough surface stainless steel stent which allows not only polymeric coating (for example biodegradable polymer, BP ISAR stent) but also coating without the need of polymer (PF ISAR stent) in the cath lab.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 605 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Randomized Trial of 3 Rapamycin-Eluting Stents With Different Polymer Coating Strategies For The Reduction of Coronary Restenosis (ISAR-TEST-3)
Study Start Date : June 2006
Actual Primary Completion Date : September 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: A
Drug eluting stent using biodegradable polymer BP stent
Device: rapamycin-eluting stent with biodegradable polymer
due to randomization, rapamycin-eluting stent with biodegradable polymer will be implanted
Active Comparator: B
polymer-free drug eluting stent PF stent
Device: polymer-free, rapamycin-eluting stent
due to randomization, polymer-free.rapamycin-eluting stent will be implanted
Active Comparator: C
permanent polymer using stents PP stent
Device: rapamycin-eluting Stent with permanent polymer
due to randomization, rapamycin-eluting stent with permanent polymer will be implanted

Primary Outcome Measures :
  1. in-stent late luminal loss [ Time Frame: at 6 to 8-month follow-up angiogram ]

Secondary Outcome Measures :
  1. In-segment binary angiographic restenosis [ Time Frame: at 6 to 8-month follow-up angiogram ]
  2. Need of target lesion revascularization [ Time Frame: at 9-month follow-up ]
  3. Combined incidence of death or myocardial infarction [ Time Frame: at 9-month follow-up ]
  4. Incidence of stent thrombosis. [ Time Frame: at 9-month follow-up ]

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

Inclusion Criteria:

  • Patients older than age 18 with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥50% de novo stenosis located in native coronary vessels.
  • Written, informed consent by the patient or her/his legally-authorized representative for participation in the study.

Exclusion Criteria:

  • Target lesion located in the left main trunk or bypass graft.
  • In-stent restenosis.
  • Cardiogenic shock.
  • Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance.
  • Known allergy to the study medications: aspirin, clopidogrel, rapamycin, stainless steel.
  • Pregnancy (present, suspected or planned) or positive pregnancy test.
  • Previous enrollment in this trial.
  • Patient's inability to fully cooperate with the study protocol.

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 identifier (NCT number): NCT00350454

1. Medizinische Klinik, Klinikum rechts der Isar
Muenchen, Germany, 81675
Deutsches Herzzentrum Muenchen
Munich, Germany, 80636
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
Study Chair: Albert Schoemig, MD Deutsches Herzzentrum Muenchen
Principal Investigator: Adnan Kastrati, MD Deutsches Herzzentrum Muenchen


Responsible Party: Prof. A. Schömig, Deutsches Herzzentrum Munich Identifier: NCT00350454     History of Changes
Other Study ID Numbers: GE IDE No. S02306
First Posted: July 10, 2006    Key Record Dates
Last Update Posted: January 11, 2008
Last Verified: January 2008

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs