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Completed

NCT Number: NCT00598676

3 Limus Agent Eluting Stents With Different Polymer Coating

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Deutsches Herzzentrum Muenchen, Munich, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

biodegradable polymer Rapamycin-eluting stent

Device

due to randomization, rapamycin-eluting stent with biodegradable polymer will be implanted

Other names: ISAR stent

permanent polymer rapamycin-eluting stent (Cypher)

Device

due to randomization, rapamycin-eluting stent with permanent polymer will be implanted

Other names: Cypher

permanent polymer everolimus-eluting stent (Xience, Promus)

Device

due to randomization, everolimus-eluting stent with permanent polymer will be implanted

Other names: Xience, Promus

Primary outcomes

  1. 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 outcomes

  1. In-segment binary restenosis at follow-up angiography

    Time frame: 6-8 months

  2. Late Lumen Loss at follow-up angiography

    Time frame: 6-8 months

  3. All cause mortality.

    Time frame: 12 months

  4. Incidence of stent thrombosis (by ARC definition)

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Deutsches Herzzentrum Muenchen

Other

Registry information

Official study 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

Acronym: ISAR-TEST-4

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jan 22, 2008
Registry last updated
Mar 15, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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