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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Coronary Heart Disease	Device: biodegradable polymer Rapamycin-eluting stent; Device: permanent polymer rapamycin-eluting stent (Cypher); Device: permanent polymer everolimus-eluting stent (Xience, Promus)	Phase 4

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	2600 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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 Start Date :	September 2007
Actual Primary Completion Date :	March 2009
Actual Study Completion Date :	April 2009

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: BPRES; biodegradable polymer rapamycin-eluting stent	Device: biodegradable polymer Rapamycin-eluting stent; due to randomization, rapamycin-eluting stent with biodegradable polymer will be implanted; Other Name: ISAR stent
Active Comparator: PPRES; permanent polymer rapamycin-eluting stent	Device: permanent polymer rapamycin-eluting stent (Cypher); due to randomization, rapamycin-eluting stent with permanent polymer will be implanted; Other Name: Cypher
Active Comparator: PPEES; permanent polymer everolimus-eluting stent	Device: permanent polymer everolimus-eluting stent (Xience, Promus); due to randomization, everolimus-eluting stent with permanent polymer will be implanted; Other Names: Xience; Promus

Outcome Measures

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Primary Outcome Measures :

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. [ Time Frame: 12 months ]

Secondary Outcome Measures :

1. In-segment binary restenosis at follow-up angiography [ Time Frame: 6-8 months ]
2. Late Lumen Loss at follow-up angiography [ Time Frame: 6-8 months ]
3. All cause mortality. [ Time Frame: 12 months ]
4. Incidence of stent thrombosis (by ARC definition) [ Time Frame: 12 months ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Germany
Medizinische Klinik, Klinikum rechts der Isar
Muenchen, Germany, 81675
Deutsches Herzzentrum Muenchen
Munich, Germany, 80636

Sponsors and Collaborators

Deutsches Herzzentrum Muenchen

Investigators

Study Chair:	Albert Schoemig, MD	Deutsches Herzzentrum Muenchen
Principal Investigator:	Adnan Kastrati, MD	Deutsches Herzzentrum Muenchen

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Byrne RA, Kastrati A, Kufner S, Massberg S, Birkmeier KA, Laugwitz KL, Schulz S, Pache J, Fusaro M, Seyfarth M, Schömig 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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Byrne RA, Kastrati A, Massberg S, Wieczorek A, Laugwitz KL, Hadamitzky M, Schulz S, Pache J, Fusaro M, Hausleiter J, Schömig 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.

Kufner S, Massberg S, Dommasch M, Byrne RA, Tiroch K, Ranftl S, Fusaro M, Schömig 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.

Responsible Party:	Prof. A. Schömig, Deutsches Herzzentrum Munich
ClinicalTrials.gov Identifier:	NCT00598676 History of Changes
Other Study ID Numbers:	GE IDE No. S02607
First Posted:	January 22, 2008
Last Update Posted:	March 15, 2010
Last Verified:	March 2010

Additional relevant MeSH terms:

Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Everolimus	Sirolimus; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Anti-Bacterial Agents; Anti-Infective Agents; Antibiotics, Antineoplastic; Antifungal Agents