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Efficacy Study of Rapamycin- vs. Zotarolimus-Eluting Stents to Reduce Coronary Restenosis (ISAR-TEST-5)

Primary Purpose

Coronary Heart Disease

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Rapamycin + Probucol-eluting stent (ISAR stent)
polymer based Zotarolimus-eluting stent (Endeavor Resolute)
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, 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dual-DES

ZES

Arm Description

Rapamycin + Probucol-eluting stent

Polymer based Zotarolimus-eluting stent

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Late luminal loss
stent thrombosis

Full Information

First Posted
January 10, 2008
Last Updated
January 3, 2012
Sponsor
Deutsches Herzzentrum Muenchen
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1. Study Identification

Unique Protocol Identification Number
NCT00598533
Brief Title
Efficacy Study of Rapamycin- vs. Zotarolimus-Eluting Stents to Reduce Coronary Restenosis
Acronym
ISAR-TEST-5
Official Title
Prospective, Randomized Trial of Rapamycin- and Zotarolimus-eluting Stents for the Reduction of Coronary Restenosis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Deutsches Herzzentrum Muenchen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

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
Outcomes Assessor
Allocation
Randomized
Enrollment
3002 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dual-DES
Arm Type
Experimental
Arm Description
Rapamycin + Probucol-eluting stent
Arm Title
ZES
Arm Type
Active Comparator
Arm Description
Polymer based Zotarolimus-eluting stent
Intervention Type
Device
Intervention Name(s)
Rapamycin + Probucol-eluting stent (ISAR stent)
Other Intervention Name(s)
ISAR stent
Intervention Description
due to randomization, Rapamycin- + Probucol-eluting stent will be implanted
Intervention Type
Device
Intervention Name(s)
polymer based Zotarolimus-eluting stent (Endeavor Resolute)
Other Intervention Name(s)
Endeavor Resolute
Intervention Description
due to randomization, Zotarolimus-eluting stent with polymer will be implanted
Primary Outcome Measure Information:
Title
A composite endpoint of cardiac death, myocardial infarction related to the target vessel or target lesion revascularisation
Time Frame
at one year
Secondary Outcome Measure Information:
Title
Late luminal loss
Time Frame
at 6-8 months follow-up angiography
Title
stent thrombosis
Time Frame
at one year

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, 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adnan Kastrati, MD
Organizational Affiliation
Deutsches Herzzentrum Muenchen
Official's Role
Study Chair
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
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
34156521
Citation
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.
Results Reference
derived
PubMed Identifier
32646563
Citation
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.
Results Reference
derived
PubMed Identifier
27586678
Citation
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.
Results Reference
derived
PubMed Identifier
27377301
Citation
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.
Results Reference
derived
PubMed Identifier
27017366
Citation
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.
Results Reference
derived
PubMed Identifier
21768546
Citation
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.
Results Reference
derived

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

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