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

Primary Purpose

Coronary Disease

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Everolimus-eluting stent (Xience)
Zotarolimus-eluting stent (Endeavor Resolute)
Sponsored by
Deutsches Herzzentrum Muenchen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Disease focused on measuring drug eluting stent, left main disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Bad Segeberger Kliniken
  • Deutsches Herzzentrum Muenchen
  • First Medizinische Klinik, Klinikum rechts der Isar
  • Azienda Ospedaliero Universitaria di Ferrara

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

EES

ZES

Arm Description

Everolimus-eluting stent (Xience)

Zotarolimus-eluting stent (Endeavor Resolute)

Outcomes

Primary Outcome Measures

Incidence of major adverse cardiac event defined as a composite of death, myocardial infarction and target lesion revascularization.

Secondary Outcome Measures

Angiographic restenosis at follow-up coronary angiography.

Full Information

First Posted
January 10, 2008
Last Updated
July 1, 2013
Sponsor
Deutsches Herzzentrum Muenchen
Collaborators
Technical University of Munich
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1. Study Identification

Unique Protocol Identification Number
NCT00598637
Brief Title
Drug-eluting Stents to Treat Unprotected Coronary Left Main Disease
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Deutsches Herzzentrum Muenchen
Collaborators
Technical University of Munich

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease
Keywords
drug eluting stent, left main disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
650 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EES
Arm Type
Active Comparator
Arm Description
Everolimus-eluting stent (Xience)
Arm Title
ZES
Arm Type
Experimental
Arm Description
Zotarolimus-eluting stent (Endeavor Resolute)
Intervention Type
Device
Intervention Name(s)
Everolimus-eluting stent (Xience)
Other Intervention Name(s)
Xience
Intervention Description
stent is implanted due to randomization
Intervention Type
Device
Intervention Name(s)
Zotarolimus-eluting stent (Endeavor Resolute)
Other Intervention Name(s)
Endeavor Resolute
Intervention Description
stent is implanted due to randomization
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Angiographic restenosis at follow-up coronary angiography.
Time Frame
6-9 months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adnan Kastrati, MD
Organizational Affiliation
Deutsches Herzzentrum Muenchen
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Julinda Mehill, MD
Organizational Affiliation
Deutsches Herzzentrum Muenchen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bad Segeberger Kliniken
City
Bad Segeberg
Country
Germany
Facility Name
Deutsches Herzzentrum Muenchen
City
Munich
ZIP/Postal Code
80636
Country
Germany
Facility Name
First Medizinische Klinik, Klinikum rechts der Isar
City
Munich
ZIP/Postal Code
81675
Country
Germany
Facility Name
Azienda Ospedaliero Universitaria di Ferrara
City
Ferrara
ZIP/Postal Code
44100
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
11583882
Citation
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. doi: 10.1016/s0735-1097(01)01491-7.
Results Reference
background
PubMed Identifier
9426015
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. doi: 10.1016/s0735-1097(97)00425-7.
Results Reference
background
PubMed Identifier
26689707
Citation
Cassese S, Kufner S, Xhepa E, Byrne RA, Kreutzer J, Ibrahim T, Tiroch K, Valgimigli M, Tolg R, Fusaro M, Schunkert H, Laugwitz KL, Mehilli J, Kastrati A. Three-year efficacy and safety of new- versus early-generation drug-eluting stents for unprotected left main coronary artery disease insights from the ISAR-LEFT MAIN and ISAR-LEFT MAIN 2 trials. Clin Res Cardiol. 2016 Jul;105(7):575-84. doi: 10.1007/s00392-015-0953-x. Epub 2015 Dec 22.
Results Reference
derived
PubMed Identifier
23973699
Citation
Mehilli J, Richardt G, Valgimigli M, Schulz S, Singh A, Abdel-Wahab M, Tiroch K, Pache J, Hausleiter J, Byrne RA, Ott I, Ibrahim T, Fusaro M, Seyfarth M, Laugwitz KL, Massberg S, Kastrati A; ISAR-LEFT-MAIN 2 Study Investigators. Zotarolimus- versus everolimus-eluting stents for unprotected left main coronary artery disease. J Am Coll Cardiol. 2013 Dec 3;62(22):2075-82. doi: 10.1016/j.jacc.2013.07.044. Epub 2013 Aug 21.
Results Reference
derived

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Drug-eluting Stents to Treat Unprotected Coronary Left Main Disease

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