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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00598637
Recruitment Status : Completed
First Posted : January 22, 2008
Last Update Posted : July 2, 2013
Technische Universität München
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen

Brief Summary:
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 or disease Intervention/treatment Phase
Coronary Disease Device: Everolimus-eluting stent (Xience) Device: Zotarolimus-eluting stent (Endeavor Resolute) Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 650 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : December 2007
Actual Primary Completion Date : September 2012
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Incidence of major adverse cardiac event defined as a composite of death, myocardial infarction and target lesion revascularization. [ Time Frame: 1 year follow-up ]

Secondary Outcome Measures :
  1. Angiographic restenosis at follow-up coronary angiography. [ Time Frame: 6-9 months follow-up ]

Information from the National Library of Medicine

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00598637

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Deutsches Herzzentrum Muenchen Identifier: NCT00598637     History of Changes
Other Study ID Numbers: GE IDE No. S02807
First Posted: January 22, 2008    Key Record Dates
Last Update Posted: July 2, 2013
Last Verified: July 2013

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

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