NCT00598676

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,600

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2007

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 22, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

March 15, 2010

Status Verified

March 1, 2010

Enrollment Period

1.5 years

First QC Date

January 10, 2008

Last Update Submit

March 12, 2010

Conditions

Coronary Heart Disease

Outcome Measures

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.

    12 months

Secondary Outcomes (4)

  • In-segment binary restenosis at follow-up angiography

    6-8 months

  • Late Lumen Loss at follow-up angiography

    6-8 months

  • All cause mortality.

    12 months

  • Incidence of stent thrombosis (by ARC definition)

    12 months

Study Arms (3)

BPRES

EXPERIMENTAL

biodegradable polymer rapamycin-eluting stent

Device: biodegradable polymer Rapamycin-eluting stent

PPRES

ACTIVE COMPARATOR

permanent polymer rapamycin-eluting stent

Device: permanent polymer rapamycin-eluting stent (Cypher)

PPEES

ACTIVE COMPARATOR

permanent polymer everolimus-eluting stent

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

Interventions

biodegradable polymer Rapamycin-eluting stentDEVICE

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

Also known as: ISAR stent
BPRES
permanent polymer rapamycin-eluting stent (Cypher)DEVICE

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

Also known as: Cypher
PPRES
permanent polymer everolimus-eluting stent (Xience, Promus)DEVICE

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

Also known as: Xience, Promus
PPEES

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Deutsches Herzzentrum Muenchen

Munich, 80636, Germany

Location

Medizinische Klinik, Klinikum rechts der Isar

München, 81675, Germany

Location

Related Publications (7)

  • 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.

    PMID: 19720642RESULT

  • 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.

    PMID: 35147767DERIVED

  • 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.

    PMID: 34075784DERIVED

  • 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.

    PMID: 30586724DERIVED

  • 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.

    PMID: 25405657DERIVED

  • 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.

    PMID: 21920260DERIVED

  • 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.

    PMID: 21400652DERIVED

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Albert Schoemig, MD

    Deutsches Herzzentrum Muenchen

    STUDY CHAIR

  • Adnan Kastrati, MD

    Deutsches Herzzentrum Muenchen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 10, 2008

First Posted

January 22, 2008

Study Start

September 1, 2007

Primary Completion

March 1, 2009

Study Completion

April 1, 2009

Last Updated

March 15, 2010

Record last verified: 2010-03

Locations

DE(2)