Drug-eluting Stents to Treat Unprotected Coronary Left Main Disease

NCT00598637 | Completed Phase 4 DMC

• 1 other identifier: GE IDE No. S02807
• Study Type: interventional
• Target: 650
• Locations: 2 countries
• Sites: 4

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.

Conditions

Coronary Disease

Keywords

drug eluting stent; left main disease

Outcome Measures

Primary Outcomes (1)

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

  1 year follow-up

Secondary Outcomes (1)

• Angiographic restenosis at follow-up coronary angiography.

  6-9 months follow-up

Study Arms (2)

EES

ACTIVE COMPARATOR

Everolimus-eluting stent (Xience)

Device: Everolimus-eluting stent (Xience)

ZES

EXPERIMENTAL

Zotarolimus-eluting stent (Endeavor Resolute)

Device: Zotarolimus-eluting stent (Endeavor Resolute)

Interventions

Everolimus-eluting stent (Xience) DEVICE

stent is implanted due to randomization

Also known as: Xience

EES

Zotarolimus-eluting stent (Endeavor Resolute) DEVICE

stent is implanted due to randomization

Also known as: Endeavor Resolute

ZES

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Deutsches Herzzentrum Muenchen: lead
• Technical University of Munich: collaborator

Study Sites (4)

Bad Segeberger Kliniken

Bad Segeberg, Germany

Location

Deutsches Herzzentrum Muenchen

Munich, 80636, Germany

Location

First Medizinische Klinik, Klinikum rechts der Isar

Munich, 81675, Germany

Location

Azienda Ospedaliero Universitaria di Ferrara

Ferrara, 44100, Italy

Location

Related Publications (4)

• 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.

  PMID: 11583882 BACKGROUND

• 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.

  PMID: 9426015 BACKGROUND

• 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.

  PMID: 26689707 DERIVED

• 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.

  PMID: 23973699 DERIVED

MeSH Terms

Conditions

Coronary Disease; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Adnan Kastrati, MD

  Deutsches Herzzentrum Muenchen

  STUDY CHAIR

• Julinda Mehill, MD

  Deutsches Herzzentrum Muenchen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2008
• First Posted: January 22, 2008
• Study Start: December 1, 2007
• Primary Completion: September 1, 2012
• Study Completion: February 1, 2013
• Last Updated: July 2, 2013

Record last verified: 2013-07

Locations

IT (1); DE (3)