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Coronary Heart DiseasePhase 4ISAR-TEST-4NCT00598676

3 Limus Agent Eluting Stents With Different Polymer Coating

A Phase 4 study testing biodegradable polymer Rapamycin-eluting stent, permanent polymer rapamycin-eluting stent (Cypher) and permanent polymer everolimus-eluting stent (Xience, Promus) in people with Coronary Heart 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
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Heart Disease
What is being tested?
biodegradable polymer Rapamycin-eluting stent, permanent polymer rapamycin-eluting stent (Cypher) and permanent polymer everolimus-eluting stent (Xience, Promus)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,600 participants
Where
2 sitesGermany
Study dates
Sep 2007to Apr 2009
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 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

Who cannot join

  • 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.
Show all 10Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • Medizinische Klinik, Klinikum rechts der Isar

    München, 81675

  • Deutsches Herzzentrum Muenchen

    Munich, 80636

Other trials in Germany

About this study

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

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.

Read the 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.

Being tested
biodegradable polymer Rapamycin-eluting stent, permanent polymer rapamycin-eluting stent (Cypher), permanent polymer everolimus-eluting stent (Xience, Promus)
Medical subject headings
Coronary Disease

What participants receive

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

  • biodegradable polymer Rapamycin-eluting stentDevice

    Also called ISAR stent

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

  • permanent polymer rapamycin-eluting stent (Cypher)Device

    Also called Cypher

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

  • permanent polymer everolimus-eluting stent (Xience, Promus)Device

    Also called Xience, Promus

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

Study groups in NCT00598676
Study groupRoleWhat they receive
BPRESExperimentalbiodegradable polymer rapamycin-eluting stent
Receives: Device: biodegradable polymer Rapamycin-eluting stent
PPRESActive comparatorpermanent polymer rapamycin-eluting stent
Receives: Device: permanent polymer rapamycin-eluting stent (Cypher)
PPEESActive comparatorpermanent polymer everolimus-eluting stent
Receives: Device: permanent polymer everolimus-eluting stent (Xience, Promus)

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 a combined endpoint of cardiac death, myocardial infarction related to the target vessel or revascularization related to the target lesion.

    Measured: 12 months

Secondary outcomes (4)

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

    Measured: 6-8 months

  2. Late Lumen Loss at follow-up angiography

    Measured: 6-8 months

  3. All cause mortality.

    Measured: 12 months

  4. Incidence of stent thrombosis (by ARC definition)

    Measured: 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 posted22 Jan 2008 (estimated)
  2. Study startSep 2007
  3. Primary completionMar 2009
  4. Study completionApr 2009

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
2,600 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00598676
Sponsor's protocol ID
GE IDE No. S02607
Acronym
ISAR-TEST-4
Status last verified
Mar 2010
First submitted
10 Jan 2008
Last updated
15 Mar 2010
Results posted
No
Data monitoring committee
Yes

Publications

  • Byrne RA, Kastrati A, Kufner S, Massberg S, Birkmeier KA, Laugwitz KL, Schulz S, Pache J, Fusaro M, Seyfarth M, Schomig A, Mehilli J; Intracoronary Stenting and Angiographic Results: Test Efficacy of 3 Limus-Eluting Stents (ISAR-TEST-4) Investigators. Randomized, non-inferiority trial of three limus agent-eluting stents with different polymer coatings: the Intracoronary Stenting and Angiographic Results: Test Efficacy of 3 Limus-Eluting Stents (ISAR-TEST-4) Trial. Eur Heart J. 2009 Oct;30(20):2441-9. doi: 10.1093/eurheartj/ehp352. Epub 2009 Aug 30.

    PubMed 19720642

  • 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

  • Lenz T, Koch T, Joner M, Xhepa E, Wiebe J, Coughlan JJ, Aytekin A, Ibrahim T, Fusaro M, Cassese S, Laugwitz KL, Schunkert H, Kastrati A, Kufner S; ISAR-TEST 4 (Intracoronary Stenting, Angiographic Results: Test Efficacy of 3 Limus-Eluting Stents) Investigators dagger. Ten-Year Clinical Outcomes of Biodegradable Versus Durable Polymer New-Generation Drug-Eluting Stent in Patients With Coronary Artery Disease With and Without Diabetes Mellitus. J Am Heart Assoc. 2021 Jun 15;10(12):e020165. doi: 10.1161/JAHA.120.020165. Epub 2021 Jun 2.

    PubMed 34075784

  • Kufner S, Joner M, Thannheimer A, Hoppmann P, Ibrahim T, Mayer K, Cassese S, Laugwitz KL, Schunkert H, Kastrati A, Byrne RA; ISAR-TEST 4 (Intracoronary Stenting and Angiographic Results: Test Efficacy of 3 Limus-Eluting Stents) Investigators. Ten-Year Clinical Outcomes From a Trial of Three Limus-Eluting Stents With Different Polymer Coatings in Patients With Coronary Artery Disease. Circulation. 2019 Jan 15;139(3):325-333. doi: 10.1161/CIRCULATIONAHA.118.038065.

    PubMed 30586724

  • Kufner S, Byrne RA, Valeskini M, Schulz S, Ibrahim T, Hoppmann P, Schneider S, Laugwitz KL, Schunkert H, Kastrati A; Intracoronary Stenting and Angiographic Results: Test Efficacy of 3 Limus-Eluting Stents (ISAR-TEST4) Investigators. Five-year outcomes from a trial of three limus-eluting stents with different polymer coatings in patients with coronary artery disease: final results from the ISAR-TEST 4 randomised trial. EuroIntervention. 2016 Mar;11(12):1372-9. doi: 10.4244/EIJY14M11_02.

    PubMed 25405657

  • Byrne RA, Kastrati A, Massberg S, Wieczorek A, Laugwitz KL, Hadamitzky M, Schulz S, Pache J, Fusaro M, Hausleiter J, Schomig A, Mehilli J; ISAR-TEST 4 Investigators. Biodegradable polymer versus permanent polymer drug-eluting stents and everolimus- versus sirolimus-eluting stents in patients with coronary artery disease: 3-year outcomes from a randomized clinical trial. J Am Coll Cardiol. 2011 Sep 20;58(13):1325-31. doi: 10.1016/j.jacc.2011.06.027.

    PubMed 21920260

  • Kufner S, Massberg S, Dommasch M, Byrne RA, Tiroch K, Ranftl S, Fusaro M, Schomig A, Kastrati A, Mehilli J; Intracoronary Stenting and Angiographic Results: Test Efficacy of 3 Limus-Eluting Stents Trial Investigators. Angiographic outcomes with biodegradable polymer and permanent polymer drug-eluting stents. Catheter Cardiovasc Interv. 2011 Aug 1;78(2):161-6. doi: 10.1002/ccd.22823. Epub 2011 Mar 11.

    PubMed 21400652

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing biodegradable polymer Rapamycin-eluting stent, permanent polymer rapamycin-eluting stent (Cypher) and permanent polymer everolimus-eluting stent (Xience, Promus) in people with Coronary Heart 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 3 inclusion and 10 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 15 Mar 2010. 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 a combined endpoint of cardiac death, myocardial infarction related to the target vessel or revascularization related to the target lesion. (time frame: 12 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 NCT00598676, which also lists 7 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 15 Mar 2010.

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