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Drug-eluting Stents to Treat Unprotected Coronary Left Main Disease (LEFT-MAIN-2)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Technische Universität München
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT00598637
First received: January 10, 2008
Last updated: January 3, 2012
Last verified: January 2012
History of Changes
  Purpose

The purpose of this study is to evaluate the efficacy of two different drug-eluting stents (Everolimus and Zotarolimus-eluting) for treatment of unprotected left main coronary artery disease.


Condition Intervention Phase
Coronary Disease
 Device: Everolimus-eluting stent (Xience)
Device: Zotarolimus-eluting stent (Endeavor Resolute)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomized Trial of Everolimus- and Zotarolimus-eluting Stents for Treatment of Unprotected Left Main Coronary Artery Disease: ISAR-LEFT-MAIN-2

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:
  • Incidence of major adverse cardiac event (MACE) defined as a composite of death, myocardial infarction and target lesion revascularization. [ Time Frame: 1 year follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Angiographic restenosis at follow-up coronary angiography. [ Time Frame: 6-9 months follow-up ] [ Designated as safety issue: No ]

Enrollment: 650
Study Start Date: December 2007
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: EES
Everolimus-eluting stent (Xience)
 Device: Everolimus-eluting stent (Xience)
stent is implanted due to randomization
Other Name: Xience
Experimental: ZES
Zotarolimus-eluting stent (Endeavor Resolute)
 Device: Zotarolimus-eluting stent (Endeavor Resolute)
stent is implanted due to randomization
Other Name: Endeavor Resolute

Detailed Description:

Restenosis in the left main coronary artery may have severe consequences given the large proportion of the myocardium compromised in this condition, and, in several studies, it has been linked to the 6-month mortality after the index procedure. Drug-eluting stents have reduced the restenosis rate and the need for target vessel revascularization not only in simple lesion but also in high risk subsets of patients and lesions such as diabetics, long lesions or bifurcations. There are no data about their efficacy in left main coronary artery disease. Thus, the aim of this study is to investigate the performance of two different drug-eluting stents (Everolimus and Zotarolimus-eluting) in left main coronary lesions.

  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 % stenosis located in unprotected LMCA who are unable to undergo CABG because of cardiac surgeons' refusal (poor surgical candidates) or their own unwillingness.
  • Pretreatment with a loading dose of 600 mg clopidogrel.
  • Informed, written consent by the patients or her/his legally-authorized representative for participation in the study.

Exclusion Criteria:

  • Cardiogenic shock.
  • ST-segment elevation acute myocardial infarction (ST-segment ≥ 0.1 mV elevation in ≥ 2 contiguous ECG leads persisting for at least 20 minutes) within 48 hours from symptom onset.
  • In-stent restenosis.
  • Malignancies or other comorbid conditions with life expectancy less than one year or that may result in protocol non-compliance.
  • Prior coronary artery bypass surgery with revascularization of LAD and/or LCx.
  • Planned staged PCI procedure within 30 days from index procedure or prior PCI within the last 30 days.
  • An elective surgical procedure is planned that would necessitate interruption of clopidogrel during the first six months post enrollment.
  • Known allergy to the study medications: aspirin, clopidogrel, UHF; sirolimus, paclitaxel; true anaphylaxis after prior exposure to contrast media.
  • Pregnancy (present, suspected or planned).
  • Patient's inability to fully cooperate with the study protocol.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00598637

Locations
Germany
Bad Segeberger Kliniken
Bad Segeberg, Germany
Deutsches Herzzentrum Muenchen
Munich, Germany, 80636
First Medizinische Klinik, Klinikum rechts der Isar
Munich, Germany, 81675
Italy
Azienda Ospedaliero Universitaria di Ferrara
Ferrara, Italy, 44100
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
Technische Universität München
Investigators
Study Chair: Adnan Kastrati, MD Deutsches Herzzentrum Muenchen
Principal Investigator: Julinda Mehill, MD Deutsches Herzzentrum Muenchen
  More Information

Publications:

Responsible Party: Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier: NCT00598637     History of Changes
Other Study ID Numbers: GE IDE No. S02807
Study First Received: January 10, 2008
Last Updated: January 3, 2012
Health Authority: Germany: German Institute of Medical Documentation and Information

Keywords provided by Deutsches Herzzentrum Muenchen:
drug eluting stent
left main disease

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Everolimus
Sirolimus
 Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 16, 2013