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Coronary DiseasePhase 4ISAR-TEST-2NCT00332397

The Efficacy of Three Different Limus Agent-Eluting Stents to Prevent Restenosis

A Phase 4 study testing Rapamycin-eluting Stent and Zotarolimus-eluting Stent in people with Coronary Disease, run by Deutsches Herzzentrum Muenchen at 2 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the efficacy of 3 different drug-eluting-stent platforms to reduce coronary artery reblockage after stent implantation Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Disease
What is being tested?
Rapamycin-eluting Stent and Zotarolimus-eluting Stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,007 participants
Where
2 sitesGermany
Study dates
Mar 2006to Jul 2007
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients older than age 18 ´ presence of 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.

Who cannot join

  • Target lesion located in the left main trunk or bypass graft In-stent restenosis Cardiogenic shock Malignancies or other comorbid conditions with life expectancy less than one year or that may result in protocol non-compliance Known allergy to the study medications: aspirin, clopidogrel, zotarolimus, sirolimus, stainless steel, or cobalt alloy Pregnancy (present, suspected or planned) or positive pregnancy test Previous enrollment in this trial Patient's inability to fully cooperate with the study protocol

Trial locations and contacts

2 sites in 1 country.

Germany2 sites
  • Deutsches Herzzentrum Muenchen

    Munich, 80636

  • First Medizinische Klinik, Klinikum rechts der Isar

    Munich, 81675

Other trials in Germany

About this study

Official title: Randomized Comparison of 3 Limus Agent-Eluting Stents for the Reduction of Coronary Restenosis

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

Read the 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 neontimal 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. Most of the DES platforms have used agents from the "limus family". Although the majority of DESs employ polymer coating to control drug storage and release, in view of the increasing safety and efficacy associated with the long-term presence of polymers a strong interest has recently been shown in the development DES platforms that do not require permanent polymers. Trials as ACTION or JUPITER II have demonstrated that not all DESs are associated with the expected improved outcomes. On the other hand, not all successful DESs have been equally effective in the reduction of restenosis. Thus, rapamycin-eluting stents (Cypher stents) have been associated with lower angiographic and clinical restenosis rates than paclitaxel-eluting stents (Taxus stents). Similarly, Cypher stents have been superior to Endeavor stents regarding the primary end point of late luminal loss in the recent ENDEAVOR III trial. Meanwhile, the on-site rapamycin-coated stents (ISAR stents) had an equivalent antiproliferative efficacy to Taxus stents in the ISAR-TEST trial. However, none of these studies evaluated angiographic restenosis as their primary endpoint and no direct comparisons between the 3 DES -Cypher, Endeavor and ISAR stents, have been performed. The Cypher stent is a stainless steel stent coated with sirolimus with use of permanent polymers while the Endeavor stent is a cobalt alloy based stent coated with zotarolimus which also uses permanent polymers for drug-storage and release. The ISAR stent is a rough surface stainless steel stent that can be coated with sirolimus in the cath lab without requiring permanent polymeric coating.

Being tested
Rapamycin-eluting Stent, Zotarolimus-eluting Stent
Medical subject headings
Coronary Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rapamycin-eluting StentDevice

    Also called Cypher

    due to randomization, Cypher stent will be implanted

  • Zotarolimus-eluting StentDevice

    Also called Endeavor

    due to randomization, Endeavor stent will be implanted

  • Rapamycin-eluting StentDevice

    due to randomization, rapamycin-eluting stent will be implanted

Study groups in NCT00332397
Study groupRoleWhat they receive
AActive comparatorRapamycin-eluting Stent (Cypher)
Receives: Device: Rapamycin-eluting Stent
BActive comparatorZotarolimus-eluting Stent (Endeavor)
Receives: Device: Zotarolimus-eluting Stent
CActive comparatorRapamycin-eluting Stent
Receives: Device: Rapamycin-eluting Stent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary end point of the study is the incidence of binary angiographic restenosis at 6-8 month follow-up angiography, measured by QCA in the in-segment area.

    Measured: 6-8 months

Secondary outcomes (4)
  1. The need of target lesion revascularization defined as any revascularization procedure involving the target lesion due to luminal re-narrowing in the presence of symptoms or objective signs of ischemia.

    Measured: 9-12 months

  2. The combined incidence of death or myocardial infarction.

    Measured: 9-12 months

  3. In-stent late luminal loss.

    Measured: 9-12 months

  4. Incidence of stent thrombosis.

    Measured: 9-12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2006 (estimated)
  2. Study startMar 2006
  3. Study completionJul 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,007 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00332397
Sponsor's protocol ID
GE IDE No. S02206
Acronym
ISAR-TEST-2
Status last verified
Jun 2008
First submitted
31 May 2006
Last updated
17 Jun 2008
Results posted
No
Data monitoring committee
Yes

Publications

  • Mehilli J, Kastrati A, Wessely R, Dibra A, Hausleiter J, Jaschke B, Dirschinger J, Schomig A; Intracoronary Stenting and Angiographic Restenosis--Test Equivalence Between 2 Drug-Eluting Stents (ISAR-TEST) Trial Investigators. Randomized trial of a nonpolymer-based rapamycin-eluting stent versus a polymer-based paclitaxel-eluting stent for the reduction of late lumen loss. Circulation. 2006 Jan 17;113(2):273-9. doi: 10.1161/CIRCULATIONAHA.105.575977. Epub 2006 Jan 3.

    PubMed 16391155
  • Dibra A, Kastrati A, Mehilli J, Pache J, Schuhlen H, von Beckerath N, Ulm K, Wessely R, Dirschinger J, Schomig A; ISAR-DIABETES Study Investigators. Paclitaxel-eluting or sirolimus-eluting stents to prevent restenosis in diabetic patients. N Engl J Med. 2005 Aug 18;353(7):663-70. doi: 10.1056/NEJMoa044372. Epub 2005 Aug 16.

    PubMed 16105990
  • Hausleiter J, Kastrati A, Wessely R, Dibra A, Mehilli J, Schratzenstaller T, Graf I, Renke-Gluszko M, Behnisch B, Dirschinger J, Wintermantel E, Schomig A; investigators of the individualizable durg-eluting Stent System to Abrogate Restenosis Project. Prevention of restenosis by a novel drug-eluting stent system with a dose-adjustable, polymer-free, on-site stent coating. Eur Heart J. 2005 Aug;26(15):1475-81. doi: 10.1093/eurheartj/ehi405. Epub 2005 Jun 23.

    PubMed 15975990
  • Windecker S, Remondino A, Eberli FR, Juni P, Raber L, Wenaweser P, Togni M, Billinger M, Tuller D, Seiler C, Roffi M, Corti R, Sutsch G, Maier W, Luscher T, Hess OM, Egger M, Meier B. Sirolimus-eluting and paclitaxel-eluting stents for coronary revascularization. N Engl J Med. 2005 Aug 18;353(7):653-62. doi: 10.1056/NEJMoa051175. Epub 2005 Aug 16.

    PubMed 16105989
  • Serruys PW, Ormiston JA, Sianos G, Sousa JE, Grube E, den Heijer P, de Feyter P, Buszman P, Schomig A, Marco J, Polonski L, Thuesen L, Zeiher AM, Bett JH, Suttorp MJ, Glogar HD, Pitney M, Wilkins GT, Whitbourn R, Veldhof S, Miquel K, Johnson R, Coleman L, Virmani R; ACTION investigators. Actinomycin-eluting stent for coronary revascularization: a randomized feasibility and safety study: the ACTION trial. J Am Coll Cardiol. 2004 Oct 6;44(7):1363-7. doi: 10.1016/j.jacc.2004.03.084.

    PubMed 15464314
  • Kastrati A, Dibra A, Eberle S, Mehilli J, Suarez de Lezo J, Goy JJ, Ulm K, Schomig A. Sirolimus-eluting stents vs paclitaxel-eluting stents in patients with coronary artery disease: meta-analysis of randomized trials. JAMA. 2005 Aug 17;294(7):819-25. doi: 10.1001/jama.294.7.819.

    PubMed 16106007
  • Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, Colombo A, Schuler G, Barragan P, Guagliumi G, Molnar F, Falotico R; RAVEL Study Group. Randomized Study with the Sirolimus-Coated Bx Velocity Balloon-Expandable Stent in the Treatment of Patients with de Novo Native Coronary Artery Lesions. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med. 2002 Jun 6;346(23):1773-80. doi: 10.1056/NEJMoa012843.

    PubMed 12050336
  • Byrne RA, Kastrati A, Tiroch K, Schulz S, Pache J, Pinieck S, Massberg S, Seyfarth M, Laugwitz KL, Birkmeier KA, Schomig A, Mehilli J; ISAR-TEST-2 Investigators. 2-year clinical and angiographic outcomes from a randomized trial of polymer-free dual drug-eluting stents versus polymer-based Cypher and Endeavor [corrected] drug-eluting stents. J Am Coll Cardiol. 2010 Jun 8;55(23):2536-43. doi: 10.1016/j.jacc.2010.03.020. Epub 2010 Apr 22.

    PubMed 20417052
  • Byrne RA, Mehilli J, Iijima R, Schulz S, Pache J, Seyfarth M, Schomig A, Kastrati A. A polymer-free dual drug-eluting stent in patients with coronary artery disease: a randomized trial vs. polymer-based drug-eluting stents. Eur Heart J. 2009 Apr;30(8):923-31. doi: 10.1093/eurheartj/ehp044. Epub 2009 Feb 24.

    PubMed 19240066

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Rapamycin-eluting Stent and Zotarolimus-eluting Stent in people with Coronary Disease, run by Deutsches Herzzentrum Muenchen at 2 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary end point of the study is the incidence of binary angiographic restenosis at 6-8 month follow-up angiography, measured by QCA in the in-segment area. (time frame: 6-8 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00332397, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2008.

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