Drug-eluting Stents to Treat Unprotected Coronary Left Main Disease

Coronary Disease Clinical Trial

— LEFT-MAIN-2  

Official title:

Prospective Randomized Trial of Everolimus- and Zotarolimus-eluting Stents for Treatment of Unprotected Left Main Coronary Artery Disease: ISAR-LEFT-MAIN-2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00598637
• Other study ID #: GE IDE No. S02807
• Status: Completed
• Phase: Phase 4
• First received: January 10, 2008
• Last updated: July 1, 2013
• Start date: December 2007
• Est. completion date: February 2013

Study information

• Verified date: July 2013
• Source: Deutsches Herzzentrum Muenchen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: German Institute of Medical Documentation and Information
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 650
• Est. completion date: February 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease

Intervention

Device:
• Everolimus-eluting stent (Xience)
stent is implanted due to randomization
• Zotarolimus-eluting stent (Endeavor Resolute)
stent is implanted due to randomization

Locations

Country	Name	City	State
Germany	Bad Segeberger Kliniken	Bad Segeberg
Germany	Deutsches Herzzentrum Muenchen	Munich
Germany	First Medizinische Klinik, Klinikum rechts der Isar	Munich
Italy	Azienda Ospedaliero Universitaria di Ferrara	Ferrara

Sponsors (2)

Lead Sponsor	Collaborator
Deutsches Herzzentrum Muenchen	Technische Universität München

Countries where clinical trial is conducted

Germany,  Italy, 

References & Publications (2)

Park SJ, Hong MK, Lee CW, Kim JJ, Song JK, Kang DH, Park SW, Mintz GS. Elective stenting of unprotected left main coronary artery stenosis: effect of debulking before stenting and intravascular ultrasound guidance. J Am Coll Cardiol. 2001 Oct;38(4):1054-60. — View Citation

Park SJ, Park SW, Hong MK, Cheong SS, Lee CW, Kim JJ, Hong MK, Mintz GS, Leon MB. Stenting of unprotected left main coronary artery stenoses: immediate and late outcomes. J Am Coll Cardiol. 1998 Jan;31(1):37-42. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of major adverse cardiac event defined as a composite of death, myocardial infarction and target lesion revascularization.		1 year follow-up	No
Secondary	Angiographic restenosis at follow-up coronary angiography.		6-9 months follow-up	No