NCT00317265

Brief Summary

This is a randomized, prospective European Multicenter Study comparing complete arterial revascularization of the coronary arteries using arterial graft material exclusively and "conventional" coronary artery bypass surgery using the left internal thoracic artery as graft to the left anterior descending artery (LAD) and vein grafts to other vessels to be bypassed.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for not_applicable coronary-artery-disease

Timeline
Completed

Started Jan 1999

Longer than P75 for not_applicable coronary-artery-disease

Geographic Reach
7 countries

14 active sites

Status
terminated

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, 1999

Completed
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 20, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 24, 2006

Completed
Last Updated

October 13, 2006

Status Verified

March 1, 2006

First QC Date

April 20, 2006

Last Update Submit

October 12, 2006

Conditions

Coronary Artery Disease

Keywords

coronary artery diseasecoronary bypass surgerycomplete arterial coronary surgeryinternal mammary artery

Outcome Measures

Primary Outcomes (1)

  • All cause mortality perioperatively, one year, five and ten years.

Secondary Outcomes (1)

  • Combined cardiac death, non-fatal myocardial infarction and repeat revascularisation at one, five and ten years.

Interventions

Coronary bypass surgeryPROCEDURE

Eligibility Criteria

Age18 Years - 71 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient eligible for surgical myocardial revascularization
  • Age 70 years or less
  • Triple vessel coronary disease with significant coronary artery stenosis defined as a stenosis of at least 50% in luminal diameter
  • Patients with stable angina pectoris (Canadian Cardiovascular Society 1, 2, 3, or 4) or unstable angina pectoris (Braunwald Classification 1b, 2b, 3b) or proven silent myocardial ischemia.

You may not qualify if:

  • No informed consent
  • Age \> 65 years
  • Participation in another study with any investigational drug or coronary revascularization procedure
  • When follow up over a period of five years is difficult or unlikely
  • Concomitant non-cardiac disease likely to limit long-term prognosis (e.g. cancer)
  • One or two vessel coronary disease and isolated left main stenosis
  • Estimated left ventricular ejection fraction \< 25%
  • Myocardial infarction within seven days
  • Need for concomitant major cardiac or non-cardiac surgery (e.g. valve surgery, left ventricular aneurysm, aortic aneurysm, carotid artery desobliteration, etc.)
  • Redo-cardiac surgery
  • Presence of the combination of insulin dependent diabetes mellitus and chronic obstructive pulmonary disease requiring therapy
  • Renal insufficiency requiring dialysis
  • Presence of the combination of severe adiposity and insulin dependent diabetes mellitus
  • Presence of the combination of severe adiposity and chronic obstructive pulmonary disease requiring therapy
  • Severe hepatic disease
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Dept. of Surgery I, AKH Linz

Linz, 4020, Austria

Location

Dept Cardiothoracic Surgery, Medical Univ. of Vienna

Vienna, A-1090, Austria

Location

Clinic for Cardiovascular Surgery, IKEM

Prague, 14000, Czechia

Location

Kardiochirurgie, Nemocnice Podlesi

Třinec, 73961, Czechia

Location

Kerckhoff-Klinik

Bad Nauheim, Germany

Location

Dept.of Cardiac Surg, Ruhr University

Bochum, 44789, Germany

Location

Dept of Cardiothoracic and Vascular Surgery, J-W-Goethe University

Frankfurt, 60590, Germany

Location

HKZ Rotenburg

Rothenburg An Der Fulda, 36199, Germany

Location

Hjerteklinikken St. Elisabeth, Regionsykehuset Trondheim

Trondheim, 7018, Norway

Location

Dept Cardiothoracic Surg, Univ. of Gdansk

Gdansk, 80211, Poland

Location

Dept of Cardiovasc Surg, Hospital Clinico, University of Barcelona

Barcelona, 08036, Spain

Location

Dept of Cardiac Surg, Hospital de Cruces

Bilbao, 48190, Spain

Location

Dept. of Cardiovascular Surgery, University of Salamanca

Salamanca, Spain

Location

Department of Cardiothoracic Surgery, University Hospital

Linköping, 58185, Sweden

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Coronary Artery Bypass

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Myocardial RevascularizationCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeVascular GraftingVascular Surgical ProceduresThoracic Surgical Procedures

Study Officials

  • Paul Simon, MD

    Dept. of Cardiothoracic Surgery, Medical Univ. of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 20, 2006

First Posted

April 24, 2006

Study Start

January 1, 1999

Study Completion

January 1, 2005

Last Updated

October 13, 2006

Record last verified: 2006-03

Locations

PL(1)ES(3)CZ(2)AU(2)DE(4)NO(1)SE(1)