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

This study has been completed.
Sponsor:
Information provided by:
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT00350454
First received: July 7, 2006
Last updated: January 10, 2008
Last verified: January 2008
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:
  • in-stent late luminal loss [ Time Frame: at 6 to 8-month follow-up angiogram ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • In-segment binary angiographic restenosis [ Time Frame: at 6 to 8-month follow-up angiogram ] [ Designated as safety issue: No ]
  • Need of target lesion revascularization [ Time Frame: at 9-month follow-up ] [ Designated as safety issue: No ]
  • Combined incidence of death or myocardial infarction [ Time Frame: at 9-month follow-up ] [ Designated as safety issue: No ]
  • Incidence of stent thrombosis. [ Time Frame: at 9-month follow-up ] [ Designated as safety issue: Yes ]

Enrollment: 605
Study Start Date: June 2006
Study Completion Date: October 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00350454

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

Publications:

Responsible Party: Prof. A. Schömig, Deutsches Herzzentrum Munich
ClinicalTrials.gov Identifier: NCT00350454     History of Changes
Other Study ID Numbers: GE IDE No. S02306
Study First Received: July 7, 2006
Last Updated: January 10, 2008
Health Authority: Germany: German Institute of Medical Documentation and Information

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

ClinicalTrials.gov processed this record on August 28, 2014