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

Sponsor:	Deutsches Herzzentrum Muenchen
Information provided by (Responsible Party):	Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:	NCT00598533

Purpose

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

Condition	Intervention	Phase
Coronary Heart Disease	Device: Rapamycin + Probucol-eluting stent (ISAR stent) Device: polymer based Zotarolimus-eluting stent (Endeavor Resolute)	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Prospective, Randomized Trial of Rapamycin- and Zotarolimus-eluting Stents for the Reduction of Coronary Restenosis

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease Heart Diseases

Drug Information available for: Probucol Sirolimus Everolimus CCI 779

U.S. FDA Resources

Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:

A composite endpoint of cardiac death, myocardial infarction related to the target vessel or target lesion revascularisation [ Time Frame: at one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Late luminal loss [ Time Frame: at 6-8 months follow-up angiography ] [ Designated as safety issue: No ]
stent thrombosis [ Time Frame: at one year ] [ Designated as safety issue: Yes ]

Enrollment:	3002
Study Start Date:	February 2008
Study Completion Date:	September 2010
Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Dual-DES Rapamycin + Probucol-eluting stent	Device: Rapamycin + Probucol-eluting stent (ISAR stent) due to randomization, Rapamycin- + Probucol-eluting stent will be implanted Other Name: ISAR stent
Active Comparator: ZES Polymer based Zotarolimus-eluting stent	Device: polymer based Zotarolimus-eluting stent (Endeavor Resolute) due to randomization, Zotarolimus-eluting stent with polymer will be implanted Other Name: Endeavor Resolute

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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, 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00598533

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:

Adnan Kastrati, MD

Deutsches Herzzentrum Muenchen

More Information

No publications provided by Deutsches Herzzentrum Muenchen

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

Massberg S, Byrne RA, Kastrati A, Schulz S, Pache J, Hausleiter J, Ibrahim T, Fusaro M, Ott I, Schömig 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. Epub 2011 Jul 18.

Responsible Party:	Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:	NCT00598533 History of Changes
Other Study ID Numbers:	GE IDE No. S02907
Study First Received:	January 10, 2008
Last Updated:	January 3, 2012
Health Authority:	Germany: German Institute of Medical Documentation and Information

Additional relevant MeSH terms:

Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Coronary Restenosis
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Coronary Stenosis
Probucol
Sirolimus
Everolimus
Anticholesteremic Agents
Hypolipidemic Agents

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Antioxidants
Protective Agents
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on February 09, 2012