Drug-eluting-stents for Unprotected Left Main Stem Disease (ISAR-LEFT-MAIN)

NCT00133237 | Completed Phase 4 DMC

• 1 other identifier: GE IDE No. S02005
• Study Type: interventional
• Target: 607
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate the efficacy of sirolimus- and paclitaxel-eluting stents for treatment of unprotected left main coronary artery disease.

Conditions

Coronary Disease

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiac events (composite of death, myocardial infarction and target lesion revascularization) at one year

  one year

Secondary Outcomes (1)

• Angiographic restenosis at 6-9 month follow-up angiography (based on left main area analysis)

  6-9 months

Study Arms (2)

A

ACTIVE COMPARATOR

Sirolimus-eluting stent (Cypher)

Device: Sirolimus-eluting stent

B

ACTIVE COMPARATOR

Paclitaxel-eluting stent (Taxus)

Device: Paclitaxel-eluting stent

Interventions

Sirolimus-eluting stent DEVICE

cypher stent is implanted due to randomization.

Also known as: Cypher

A

Paclitaxel-eluting stent DEVICE

taxus stent is implanted due to randomization.

Also known as: Taxus

B

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 coronary artery bypass graft (CABG)
• Pretreatment with a loading dose of 300-600 mg clopidogrel
• Informed, written consent

You may not qualify if:

• Cardiogenic shock;
• ST-segment elevation acute myocardial infarction within 48 h from symptom onset;
• In-stent restenosis;
• Malignancies or other comorbid conditions with life expectancy less than one year;
• Prior coronary artery bypass surgery with revascularization of left anterior descending (LAD) and/or left circumflex (LCx) coronary artery
• Planned staged percutaneous coronary intervention (PCI) procedure within 30 days from index procedure or prior PCI within the last 30 days
• Left main size \>4.5mm
• An elective surgical procedure is planned during the first six months post enrolment;
• Known allergy to the study medications
• Pregnancy
• Patient's inability to fully cooperate with the study protocol

Sponsors & Collaborators

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

Study Sites (2)

Deutsches Herzzentrum

Munich, 80636, Germany

Location

First Medizinische Klinik, Klinikum rechts der Isar

Munich, 81675, Germany

Location

Related Publications (10)

• Ellis SG, Tamai H, Nobuyoshi M, Kosuga K, Colombo A, Holmes DR, Macaya C, Grines CL, Whitlow PL, White HJ, Moses J, Teirstein PS, Serruys PW, Bittl JA, Mooney MR, Shimshak TM, Block PC, Erbel R. Contemporary percutaneous treatment of unprotected left main coronary stenoses: initial results from a multicenter registry analysis 1994-1996. Circulation. 1997 Dec 2;96(11):3867-72. doi: 10.1161/01.cir.96.11.3867.

  PMID: 9403609 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

• Takagi T, Stankovic G, Finci L, Toutouzas K, Chieffo A, Spanos V, Liistro F, Briguori C, Corvaja N, Albero R, Sivieri G, Paloschi R, Di Mario C, Colombo A. Results and long-term predictors of adverse clinical events after elective percutaneous interventions on unprotected left main coronary artery. Circulation. 2002 Aug 6;106(6):698-702. doi: 10.1161/01.cir.0000024983.34728.5d.

  PMID: 12163430 BACKGROUND

• Ellis SG, Hill CM, Lytle BW. Spectrum of surgical risk for left main coronary stenoses: benchmark for potentially competing percutaneous therapies. Am Heart J. 1998 Feb;135(2 Pt 1):335-8. doi: 10.1016/s0002-8703(98)70102-4.

  PMID: 9489985 BACKGROUND

• Chieffo A, Stankovic G, Bonizzoni E, Tsagalou E, Iakovou I, Montorfano M, Airoldi F, Michev I, Sangiorgi MG, Carlino M, Vitrella G, Colombo A. Early and mid-term results of drug-eluting stent implantation in unprotected left main. Circulation. 2005 Feb 15;111(6):791-5. doi: 10.1161/01.CIR.0000155256.88940.F8. Epub 2005 Feb 7.

  PMID: 15699254 BACKGROUND

• Valgimigli M, van Mieghem CA, Ong AT, Aoki J, Granillo GA, McFadden EP, Kappetein AP, de Feyter PJ, Smits PC, Regar E, Van der Giessen WJ, Sianos G, de Jaegere P, Van Domburg RT, Serruys PW. Short- and long-term clinical outcome after drug-eluting stent implantation for the percutaneous treatment of left main coronary artery disease: insights from the Rapamycin-Eluting and Taxus Stent Evaluated At Rotterdam Cardiology Hospital registries (RESEARCH and T-SEARCH). Circulation. 2005 Mar 22;111(11):1383-9. doi: 10.1161/01.CIR.0000158486.20865.8B.

  PMID: 15781749 BACKGROUND

• Silber S, Albertsson P, Aviles FF, Camici PG, Colombo A, Hamm C, Jorgensen E, Marco J, Nordrehaug JE, Ruzyllo W, Urban P, Stone GW, Wijns W; Task Force for Percutaneous Coronary Interventions of the European Society of Cardiology. Guidelines for percutaneous coronary interventions. The Task Force for Percutaneous Coronary Interventions of the European Society of Cardiology. Eur Heart J. 2005 Apr;26(8):804-47. doi: 10.1093/eurheartj/ehi138. Epub 2005 Mar 15.

  PMID: 15769784 BACKGROUND

• Mehilli J, Kastrati A, Byrne RA, Bruskina O, Iijima R, Schulz S, Pache J, Seyfarth M, Massberg S, Laugwitz KL, Dirschinger J, Schomig A; LEFT-MAIN Intracoronary Stenting and Angiographic Results: Drug-Eluting Stents for Unprotected Coronary Left Main Lesions Study Investigators. Paclitaxel- versus sirolimus-eluting stents for unprotected left main coronary artery disease. J Am Coll Cardiol. 2009 May 12;53(19):1760-8. doi: 10.1016/j.jacc.2009.01.035.

  PMID: 19422982 RESULT

• 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

• Tiroch K, Mehilli J, Byrne RA, Schulz S, Massberg S, Laugwitz KL, Vorpahl M, Seyfarth M, Kastrati A; ISAR-LEFT MAIN Study Investigators. Impact of coronary anatomy and stenting technique on long-term outcome after drug-eluting stent implantation for unprotected left main coronary artery disease. JACC Cardiovasc Interv. 2014 Jan;7(1):29-36. doi: 10.1016/j.jcin.2013.08.013. Epub 2013 Dec 11.

  PMID: 24332416 DERIVED

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Albert Schömig, MD

  Deutsches Herzzentrum Muenchen

  STUDY CHAIR

• Adnan Kastrati, 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

Study Record Dates

• First Submitted: August 22, 2005
• First Posted: August 23, 2005
• Study Start: July 1, 2005
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: March 15, 2010

Record last verified: 2008-10

Locations

DE (2)