NCT00375063

Brief Summary

Unprotected left main coronary artery (ULMCA) stenting, offering restoration of a native flow to left coronary artery, is the subject of intense investigations as a potential alternative to bypass surgery. The purpose of the study is to compare the short and long term results of unprotected left main stenting with coronary artery bypass surgery.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2001

Longer than P75 for phase_4

Geographic Reach
2 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 12, 2006

Completed
Last Updated

September 12, 2006

Status Verified

September 1, 2006

First QC Date

September 11, 2006

Last Update Submit

September 11, 2006

Conditions

Coronary Artery StenosisMyocardial RevascularizationMyocardial Ischemia

Keywords

left main stenosisPercutaneous Coronary InterventionCoronary Artery Bypass Grafting

Outcome Measures

Primary Outcomes (3)

  • LV function assessed by 2D echocardiography

  • exercise tolerance measured with ECG treadmill stress testing

  • angina severity according to CCS classification 12 months after the index intervention

Secondary Outcomes (5)

  • 30 day and one year major adverse events (MAE)

  • 30 day and one year major acute cardiovascular events (MACE)

  • length of hospitalization

  • one year and total survival and freedom from MACE

  • one year target vessel failure (TVF).

Interventions

Percutaneous Coronary InterventionPROCEDURE
Coronary Artery Bypass GraftingPROCEDURE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patients' age 18 to 80
  • Significant LM stenosis (\>50%)
  • The target vessel reference diameter 2.5mm.
  • Concomitant multivessel disease suitable for PCI is allowed.
  • The patient is an acceptable candidate for coronary artery bypass surgery.
  • The patient agreement for 6 month follow-up cardiac catheterization, which will include left ventricular angiogram.
  • The patient written informed consent.

You may not qualify if:

  • An allergy or contraindication to aspirin, ticlopidine or Clopidogrel.
  • Presence of diffuse, significant (\>++) calcifications in LM
  • Left ventricular ejection fraction \< 35%
  • History of bleeding diathesis or coagulopathy.
  • Any previous PCI or CABG surgery
  • Acute MI within 48 hours, cardiogenic shock.
  • Bail-out stenting of dissected LM during complicated PCI.
  • The patient suffered a stroke or transient ischemic neurological attack (TIA) within 3 months.
  • Chronic renal insufficiency.
  • Positive pregnancy test.
  • Any disease that may shorten the life expectancy of the patient.
  • The patient is currently participating in another research study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Sharpe-Strumia Research Foundation of the Bryn Mawr Hospital, Bryn Mawr, PA, USA and Thomas Jefferson University, Philadelphia

Bryn Mawr, Pennsylvania, 19010, United States

Location

San Antonio Endovascular and Heart Institute and University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78248, United States

Location

Jagiellonian University

Krakow, Lesser Poland Voivodeship, 31-147, Poland

Location

Silesian Medical School 1-st Department of Cardiosurgery

Katowice, Silesian Voivodeship, 40-635, Poland

Location

Silesian Medical School 3-rd Department of Cardiology, Coronary Care Unit

Katowice, Silesian Voivodeship, 40-635, Poland

Location

Related Publications (6)

  • Chieffo A, Colombo A. Treatment of unprotected left main coronary artery disease with drug-eluting stents: is it time for a randomized trial? Nat Clin Pract Cardiovasc Med. 2005 Aug;2(8):396-400. doi: 10.1038/ncpcardio0272.

    PMID: 16119701BACKGROUND

  • 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: 15699254BACKGROUND

  • Park SJ, Kim YH, Lee BK, Lee SW, Lee CW, Hong MK, Kim JJ, Mintz GS, Park SW. Sirolimus-eluting stent implantation for unprotected left main coronary artery stenosis: comparison with bare metal stent implantation. J Am Coll Cardiol. 2005 Feb 1;45(3):351-6. doi: 10.1016/j.jacc.2004.10.039.

    PMID: 15680711BACKGROUND

  • 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: 15781749BACKGROUND

  • Peszek-Przybyla E, Buszman P, Bialkowska B, Zurakowski L, Banasiewicz-Szkrobka I, Debinski M, Tendera M. Stent implantation for the unprotected left main coronary artery. The long-term outcome of 62 patients. Kardiol Pol. 2006 Jan;64(1):1-6; discussion 7.

    PMID: 16444619RESULT

  • Buszman PE, Kiesz SR, Bochenek A, Peszek-Przybyla E, Szkrobka I, Debinski M, Bialkowska B, Dudek D, Gruszka A, Zurakowski A, Milewski K, Wilczynski M, Rzeszutko L, Buszman P, Szymszal J, Martin JL, Tendera M. Acute and late outcomes of unprotected left main stenting in comparison with surgical revascularization. J Am Coll Cardiol. 2008 Feb 5;51(5):538-45. doi: 10.1016/j.jacc.2007.09.054.

    PMID: 18237682DERIVED

MeSH Terms

Conditions

Coronary StenosisMyocardial Ischemia

Interventions

Percutaneous Coronary InterventionCoronary Artery Bypass

Condition Hierarchy (Ancestors)

Coronary DiseaseHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresMyocardial RevascularizationCardiac Surgical ProceduresVascular GraftingThoracic Surgical Procedures

Study Officials

  • Pawel E Buszman, Prof

    Silesian Medical School, Poland

    PRINCIPAL INVESTIGATOR

  • Stefan R Kiesz, Prof

    2San Antonio Endovascular and Heart Institute and University of Texas Health Science Center at San Antonio, Tx, USA,

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 11, 2006

First Posted

September 12, 2006

Study Start

January 1, 2001

Study Completion

December 1, 2005

Last Updated

September 12, 2006

Record last verified: 2006-09

Locations

US(2)PL(3)