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3 Limus Agent Eluting Stents With Different Polymer Coating (ISAR-TEST-4)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00598676
First Posted: January 22, 2008
Last Update Posted: March 15, 2010
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.
Information provided by:
Deutsches Herzzentrum Muenchen
  Purpose
The aim of this study is to determine whether biodegradable polymer based rapamycin-eluting stent performs equal to permanent polymer based everolimus- and rapamycin-eluting stents regarding reduction of adverse cardiac events at one year.

Condition Intervention Phase
Coronary Heart Disease Device: biodegradable polymer Rapamycin-eluting stent Device: permanent polymer rapamycin-eluting stent (Cypher) Device: permanent polymer everolimus-eluting stent (Xience, Promus) Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intracoronary Stenting and Angiographic Results: Test Efficacy of 3 Limus-Eluting STents (ISAR-TEST 4): Prospective, Randomized Trial of 3-limus Agent-eluting Stents With Different Polymer Coatings

Resource links provided by NLM:


Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:
  • The primary end point of the study is a combined endpoint of cardiac death, myocardial infarction related to the target vessel or revascularization related to the target lesion. [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • In-segment binary restenosis at follow-up angiography [ Time Frame: 6-8 months ]
  • Late Lumen Loss at follow-up angiography [ Time Frame: 6-8 months ]
  • All cause mortality. [ Time Frame: 12 months ]
  • Incidence of stent thrombosis (by ARC definition) [ Time Frame: 12 months ]

Enrollment: 2600
Study Start Date: September 2007
Study Completion Date: April 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BPRES
biodegradable polymer rapamycin-eluting stent
Device: biodegradable polymer Rapamycin-eluting stent
due to randomization, rapamycin-eluting stent with biodegradable polymer will be implanted
Other Name: ISAR stent
Active Comparator: PPRES
permanent polymer rapamycin-eluting stent
Device: permanent polymer rapamycin-eluting stent (Cypher)
due to randomization, rapamycin-eluting stent with permanent polymer will be implanted
Other Name: Cypher
Active Comparator: PPEES
permanent polymer everolimus-eluting stent
Device: permanent polymer everolimus-eluting stent (Xience, Promus)
due to randomization, everolimus-eluting stent with permanent polymer will be implanted
Other Names:
  • Xience
  • Promus

Detailed Description:

Drug-eluting stents significantly reduce in-stent restenosis and the subsequent need for target vessel revascularisation compared with bare metal stents. Although this applies to the vast majority of patients, intimal hyperplasia and in-stent restenosis have not been completely eliminated and remain to occur in certain high risk subgroups. Thus there is ongoing research for new, potentially more effective and safe drug-eluting stent systems.

One direction of extensive research is the search of new polymers such as biodegradable polymers which allow a controlled drug-release and disappear with time, reducing the probability of polymer-induced chronic inflammation on the vessel wall.

Another direction is finding new drugs to suppress neointimal hyperplasia. Promising preclinical and clinical results suggest that the Everolimus eluting stent platform might provide potential improvements over prior generations of drug-eluting stents.

  Eligibility

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 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.
  • In women with childbearing potential a negative pregnancy test is mandatory

Exclusion Criteria:

  • Target lesion located in the left main trunk.
  • Target lesion located in the 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: Clopidogrel, Rapamycin, Everolimus, stainless steel or cobalt chrome.
  • Inability to take clopidogrel for at least 6 months.
  • 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
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): NCT00598676


Locations
Germany
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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. A. Schömig, Deutsches Herzzentrum Munich
ClinicalTrials.gov Identifier: NCT00598676     History of Changes
Other Study ID Numbers: GE IDE No. S02607
First Submitted: January 10, 2008
First Posted: January 22, 2008
Last Update Posted: March 15, 2010
Last Verified: March 2010

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


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