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

This study has been completed.
Sponsor:
Collaborator:
Technische Universität München
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT00598637
First received: January 10, 2008
Last updated: July 1, 2013
Last verified: July 2013

January 10, 2008
July 1, 2013
December 2007
September 2012   (final data collection date for primary outcome measure)
Incidence of major adverse cardiac event defined as a composite of death, myocardial infarction and target lesion revascularization. [ Time Frame: 1 year follow-up ] [ Designated as safety issue: No ]
incidence of MACE defined as a composite of death, MI and Target Lesion revascularization (TLR). [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00598637 on ClinicalTrials.gov Archive Site
Angiographic restenosis at follow-up coronary angiography. [ Time Frame: 6-9 months follow-up ] [ Designated as safety issue: No ]
Angiographic restenosis at follow-up coronary angiography [ Time Frame: 6-9 months FU ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Drug-eluting Stents to Treat Unprotected Coronary Left Main Disease
Prospective Randomized Trial of Everolimus- and Zotarolimus-eluting Stents for Treatment of Unprotected Left Main Coronary Artery Disease: ISAR-LEFT-MAIN-2

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Coronary Disease
  • Device: Everolimus-eluting stent (Xience)
    stent is implanted due to randomization
    Other Name: Xience
  • Device: Zotarolimus-eluting stent (Endeavor Resolute)
    stent is implanted due to randomization
    Other Name: Endeavor Resolute
  • Active Comparator: EES
    Everolimus-eluting stent (Xience)
    Intervention: Device: Everolimus-eluting stent (Xience)
  • Experimental: ZES
    Zotarolimus-eluting stent (Endeavor Resolute)
    Intervention: Device: Zotarolimus-eluting stent (Endeavor Resolute)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
650
February 2013
September 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy,   Germany
 
NCT00598637
GE IDE No. S02807
Yes
Deutsches Herzzentrum Muenchen
Deutsches Herzzentrum Muenchen
Technische Universität München
Study Chair: Adnan Kastrati, MD Deutsches Herzzentrum Muenchen
Principal Investigator: Julinda Mehill, MD Deutsches Herzzentrum Muenchen
Deutsches Herzzentrum Muenchen
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP