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3 Limus Agent Eluting Stents With Different Polymer Coating (ISAR-TEST-4)

Primary Purpose

Coronary Heart Disease

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
biodegradable polymer Rapamycin-eluting stent
permanent polymer rapamycin-eluting stent (Cypher)
permanent polymer everolimus-eluting stent (Xience, Promus)
Sponsored by
Deutsches Herzzentrum Muenchen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Heart Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medizinische Klinik, Klinikum rechts der Isar
  • Deutsches Herzzentrum Muenchen

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

BPRES

PPRES

PPEES

Arm Description

biodegradable polymer rapamycin-eluting stent

permanent polymer rapamycin-eluting stent

permanent polymer everolimus-eluting stent

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

In-segment binary restenosis at follow-up angiography
Late Lumen Loss at follow-up angiography
All cause mortality.
Incidence of stent thrombosis (by ARC definition)

Full Information

First Posted
January 10, 2008
Last Updated
March 12, 2010
Sponsor
Deutsches Herzzentrum Muenchen
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1. Study Identification

Unique Protocol Identification Number
NCT00598676
Brief Title
3 Limus Agent Eluting Stents With Different Polymer Coating
Acronym
ISAR-TEST-4
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Deutsches Herzzentrum Muenchen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2600 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BPRES
Arm Type
Experimental
Arm Description
biodegradable polymer rapamycin-eluting stent
Arm Title
PPRES
Arm Type
Active Comparator
Arm Description
permanent polymer rapamycin-eluting stent
Arm Title
PPEES
Arm Type
Active Comparator
Arm Description
permanent polymer everolimus-eluting stent
Intervention Type
Device
Intervention Name(s)
biodegradable polymer Rapamycin-eluting stent
Other Intervention Name(s)
ISAR stent
Intervention Description
due to randomization, rapamycin-eluting stent with biodegradable polymer will be implanted
Intervention Type
Device
Intervention Name(s)
permanent polymer rapamycin-eluting stent (Cypher)
Other Intervention Name(s)
Cypher
Intervention Description
due to randomization, rapamycin-eluting stent with permanent polymer will be implanted
Intervention Type
Device
Intervention Name(s)
permanent polymer everolimus-eluting stent (Xience, Promus)
Other Intervention Name(s)
Xience, Promus
Intervention Description
due to randomization, everolimus-eluting stent with permanent polymer will be implanted
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
In-segment binary restenosis at follow-up angiography
Time Frame
6-8 months
Title
Late Lumen Loss at follow-up angiography
Time Frame
6-8 months
Title
All cause mortality.
Time Frame
12 months
Title
Incidence of stent thrombosis (by ARC definition)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albert Schoemig, MD
Organizational Affiliation
Deutsches Herzzentrum Muenchen
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Adnan Kastrati, MD
Organizational Affiliation
Deutsches Herzzentrum Muenchen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medizinische Klinik, Klinikum rechts der Isar
City
Muenchen
ZIP/Postal Code
81675
Country
Germany
Facility Name
Deutsches Herzzentrum Muenchen
City
Munich
ZIP/Postal Code
80636
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
19720642
Citation
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.
Results Reference
result
PubMed Identifier
35147767
Citation
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.
Results Reference
derived
PubMed Identifier
34075784
Citation
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.
Results Reference
derived
PubMed Identifier
30586724
Citation
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.
Results Reference
derived
PubMed Identifier
25405657
Citation
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.
Results Reference
derived
PubMed Identifier
21920260
Citation
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.
Results Reference
derived
PubMed Identifier
21400652
Citation
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.
Results Reference
derived

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3 Limus Agent Eluting Stents With Different Polymer Coating

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