ClinicalTrials.gg
Sign In
CompletedNCT00598533ISAR-TEST-5Updated Jan 5, 2012

Efficacy Study of Rapamycin- vs. Zotarolimus-Eluting Stents to Reduce Coronary Restenosis

A Phase 4 interventional study of Rapamycin + Probucol-eluting stent (ISAR stent) and polymer based Zotarolimus-eluting stent (Endeavor Resolute) in Coronary Heart Disease, sponsored by Deutsches Herzzentrum Muenchen. Completed at 2 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-01-05.

Sponsored by Deutsches Herzzentrum Muenchen · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
3,002
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this trial is to evaluate the efficacy of Rapamycin- and Zotarolimus-Eluting stents for the reduction of Coronary Restenosis

Read the detailed description

This prospective, randomized trial will compare the efficacy and safety of a Rapamycin plus Probucol-eluting stent with a polymer based Zotarolimus-eluting stent. Patients with symptomatic coronary artery disease without cardiogenic shock who will undergo coronary angiography and willing to participate in the trial will receive a loading dose of 600mg clopidogrel at least 2 hours before the procedure. They will be randomized to receive one of the above mentioned stents.

02

Conditions studied

  • Coronary Heart Disease

Browse trials for

03

In context

Coronary Disease

2,867 studies on the registry are indexed under Coronary Disease; 309 are open to participants now.

This study's enrollment of 3,002 is above the median of 124 across 1,601 interventional studies indexed under Coronary Disease.

Browse Coronary Disease studies →

Lead sponsor

Deutsches Herzzentrum Muenchen is the lead sponsor of 114 studies on the registry; 10 are open to participants now.

Browse Deutsches Herzzentrum Muenchen studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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, Probucol, Zotarolimus, 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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
3,002 participants (actual)

Study arms

  • Experimental
    Dual-DES

    Rapamycin + Probucol-eluting stent

    Device: Rapamycin + Probucol-eluting stent (ISAR stent)

  • Active comparator
    ZES

    Polymer based Zotarolimus-eluting stent

    Device: polymer based Zotarolimus-eluting stent (Endeavor Resolute)

Interventions

  • DeviceRapamycin + Probucol-eluting stent (ISAR stent)

    due to randomization, Rapamycin- + Probucol-eluting stent will be implanted

    Also known as: ISAR stent

  • Devicepolymer based Zotarolimus-eluting stent (Endeavor Resolute)

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

    Also known as: Endeavor Resolute

06

What researchers measure

Primary outcomes

  1. A composite endpoint of cardiac death, myocardial infarction related to the target vessel or target lesion revascularisation

    Time frame: at one year

Secondary outcomes

  1. Late luminal loss

    Time frame: at 6-8 months follow-up angiography

  2. stent thrombosis

    Time frame: at one year

07

Study locations

2 sites
  • Deutsches Herzzentrum Muenchen
    Munich, 80636, Germany
  • Medizinische Klinik, Klinikum rechts der Isar
    München, 81675, Germany
08

References and documents

Publications

  • Coughlan JJ, Aytekin A, Xhepa E, Cassese S, Joner M, Koch T, Wiebe J, Lenz T, Rheude T, Pellegrini C, Gewalt S, Ibrahim T, Laugwitz KL, Schunkert H, Kastrati A, Kufner S. Target and non-target vessel related events at 10 years post percutaneous coronary intervention. Clin Res Cardiol. 2022 Jul;111(7):787-794. doi: 10.1007/s00392-022-01986-4. Epub 2022 Feb 11. PubMed 35147767 ↗
  • Koch T, Lenz T, Joner M, Xhepa E, Koppara T, Wiebe J, Coughlan JJ, Aytekin A, Ibrahim T, Kessler T, Cassese S, Laugwitz KL, Schunkert H, Kastrati A, Kufner S; Intracoronary Stenting and Angiographic Results: Test Efficacy of Sirolimus- and Probucol-Eluting Versus Zotarolimus- Eluting Stents (ISAR-TEST 5) Investigators. Ten-year clinical outcomes of polymer-free versus durable polymer new-generation drug-eluting stent in patients with coronary artery disease with and without diabetes mellitus : Results of the Intracoronary Stenting and Angiographic Results: Test Efficacy of Sirolimus- and Probucol- and Zotarolimus-Eluting Stents (ISAR-TEST 5) trial. Clin Res Cardiol. 2021 Oct;110(10):1586-1598. doi: 10.1007/s00392-021-01854-7. Epub 2021 Jun 22. PubMed 34156521 ↗
  • Kufner S, Ernst M, Cassese S, Joner M, Mayer K, Colleran R, Koppara T, Xhepa E, Koch T, Wiebe J, Ibrahim T, Fusaro M, Laugwitz KL, Schunkert H, Kastrati A, Byrne RA; ISAR-TEST-5 Investigators. 10-Year Outcomes From a Randomized Trial of Polymer-Free Versus Durable Polymer Drug-Eluting Coronary Stents. J Am Coll Cardiol. 2020 Jul 14;76(2):146-158. doi: 10.1016/j.jacc.2020.05.026. PubMed 32646563 ↗
  • Harada Y, Colleran R, Kufner S, Giacoppo D, Rheude T, Michel J, Cassese S, Ibrahim T, Laugwitz KL, Kastrati A, Byrne RA; Intracoronary Stenting and Angiographic Results: Test Efficacy of Sirolimus- and Probucol- and Zotarolimus- Eluting Stents (ISAR-TEST 5) Investigators. Five-year clinical outcomes in patients with diabetes mellitus treated with polymer-free sirolimus- and probucol-eluting stents versus second-generation zotarolimus-eluting stents: a subgroup analysis of a randomized controlled trial. Cardiovasc Diabetol. 2016 Sep 1;15(1):124. doi: 10.1186/s12933-016-0429-y. PubMed 27586678 ↗
  • Colleran R, Kufner S, Harada Y, Giacoppo D, Cassese S, Repp J, Wiebe J, Lohaus R, Lahmann A, Schneider S, Ibrahim T, Laugwitz KL, Kastrati A, Byrne RA; Intracoronary Stenting and Angiographic Results: Test Efficacy of Sirolimus- and Probucol-Eluting Versus Zotarolimus-Eluting Stents (ISAR-TEST 5) Investigators. Five-year follow-up of polymer-free sirolimus- and probucol-eluting stents versus new generation zotarolimus-eluting stents in patients presenting with st-elevation myocardial infarction. Catheter Cardiovasc Interv. 2017 Feb 15;89(3):367-374. doi: 10.1002/ccd.26597. Epub 2016 Jul 5. PubMed 27377301 ↗
  • Kufner S, Sorges J, Mehilli J, Cassese S, Repp J, Wiebe J, Lohaus R, Lahmann A, Rheude T, Ibrahim T, Massberg S, Laugwitz KL, Kastrati A, Byrne RA; ISAR-TEST-5 Investigators. Randomized Trial of Polymer-Free Sirolimus- and Probucol-Eluting Stents Versus Durable Polymer Zotarolimus-Eluting Stents: 5-Year Results of the ISAR-TEST-5 Trial. JACC Cardiovasc Interv. 2016 Apr 25;9(8):784-792. doi: 10.1016/j.jcin.2016.01.009. Epub 2016 Mar 23. PubMed 27017366 ↗
  • Massberg S, Byrne RA, Kastrati A, Schulz S, Pache J, Hausleiter J, Ibrahim T, Fusaro M, Ott I, Schomig A, Laugwitz KL, Mehilli J; Intracoronary Stenting and Angiographic Results: Test Efficacy of Sirolimus- and Probucol-Eluting Versus Zotarolimus- Eluting Stents (ISAR-TEST 5) Investigators. Polymer-free sirolimus- and probucol-eluting versus new generation zotarolimus-eluting stents in coronary artery disease: the Intracoronary Stenting and Angiographic Results: Test Efficacy of Sirolimus- and Probucol-Eluting versus Zotarolimus-eluting Stents (ISAR-TEST 5) trial. Circulation. 2011 Aug 2;124(5):624-32. doi: 10.1161/CIRCULATIONAHA.111.026732. Epub 2011 Jul 18. PubMed 21768546 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 5, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00598533
Lead sponsor
Deutsches Herzzentrum Muenchen
Responsible party
Sponsor
First posted
Jan 22, 2008
Start date
Feb 2008
Primary completion
Aug 2010
Completion
Sep 2010
Last update
Jan 5, 2012

Study contacts

Adnan Kastrati, MD
study chair · Deutsches Herzzentrum Muenchen

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Coronary Disease →

Other studies from this sponsor

Deutsches Herzzentrum Muenchen →

Start the discussion