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

July 1, 2013 updated by: Deutsches Herzzentrum Muenchen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

650

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Segeberg, Germany
        • Bad Segeberger Kliniken
      • Munich, Germany, 80636
        • Deutsches Herzzentrum Muenchen
      • Munich, Germany, 81675
        • First Medizinische Klinik, Klinikum rechts der Isar
  • Italy
      • Ferrara, Italy, 44100
        • Azienda Ospedaliero Universitaria di Ferrara

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: EES
Everolimus-eluting stent (Xience)
Device: Everolimus-eluting stent (Xience)
stent is implanted due to randomization
Other Names:
  • Xience
Experimental: ZES
Zotarolimus-eluting stent (Endeavor Resolute)
Device: Zotarolimus-eluting stent (Endeavor Resolute)
stent is implanted due to randomization
Other Names:
  • Endeavor Resolute

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Angiographic restenosis at follow-up coronary angiography.
Time Frame: 6-9 months follow-up
6-9 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Deutsches Herzzentrum Muenchen

Collaborators

Technical University of Munich

Investigators

  • Study Chair: Adnan Kastrati, MD, Deutsches Herzzentrum Muenchen
  • Principal Investigator: Julinda Mehill, MD, Deutsches Herzzentrum Muenchen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

January 10, 2008

First Submitted That Met QC Criteria

January 21, 2008

First Posted (Estimate)

January 22, 2008

Study Record Updates

Last Update Posted (Estimate)

July 2, 2013

Last Update Submitted That Met QC Criteria

July 1, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GE IDE No. S02807

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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