NCT00187356

Brief Summary

Bypass surgery is often required to treat severe coronary heart disease. Either arteries or veins can be used as bypass grafts. We wish to compare the long-term durability of the saphenous vein from the leg to that of the radial artery from the fore-arm when used as bypass grafts. We are examining how many of these grafts are still functioning beyond 5 years after bypass surgery by performing a coronary angiogram. After 1-year, we found that radial arteries were more likely to be functioning than saphenous veins. We hypothesize that radial arteries will continue to be superior beyond 5 years.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
269

participants targeted

Target at P50-P75 for phase_3 coronary-artery-disease

Timeline
Completed

Started Jul 2002

Longer than P75 for phase_3 coronary-artery-disease

Geographic Reach
2 countries

13 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

July 1, 2002

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

June 5, 2013

Status Verified

June 1, 2013

Enrollment Period

8.2 years

First QC Date

September 10, 2005

Last Update Submit

June 4, 2013

Conditions

Coronary Artery Disease

Keywords

Coronary Bypass SurgeryCoronary Artery DiseaseAngiographyArterial GraftsRadial ArterySaphenous Vein

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint will be the proportion of grafts which are functionally occluded (TIMI flow 0, 1, or 2).

    Beyond 5 years after bypass urgery

Secondary Outcomes (4)

  • a) the proportion of occluded study grafts (TIMI 0)

    Beyond 5 years after bypass urgery

  • b) the proportion of functionally occluded grafts where proximal stenosis of native vessel is <90% vs >90%

    Beyond 5 years after bypass urgery

  • c) the proportion of completely occluded grafts where proximal stenosis of native vessel is <90% vs >90%

    Beyond 5 years after bypass urgery

  • d) proportion of study grafts with string sign

    Beyond 5 years after bypass urgery

Study Arms (1)

Surgical Conduit

EXPERIMENTAL

The surgical arm will be composed of the experimental arm (the use of the radial artery) versus an active comparator (the use of the saphenous vein graft).

Procedure: Radial Artery and Saphenous Vein Grafts Randomized to either right coronary or left circumflex coronary artery territories

Interventions

Radial Artery and Saphenous Vein Grafts Randomized to either right coronary or left circumflex coronary artery territoriesPROCEDURE

Each patient will receive both study grafts (Radial artery and Study Saphenous vein graft). The within-patient randomization scheme will dictate whether the radial goes to the right or circumflex territory. The saphenous vein graft will go to the opposing territory.

Surgical Conduit

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patient population consists of patients who were enroled into the original Multicentre Radial Artery Patency Study between November 1996 and January 2001. These included patients undergoing isolated coronary artery bypass surgery less than 80 years of age with 3 vessel coronary disease and left ventricular ejection fraction greater than 35%.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

University of Alberta

Edmonton, Alberta, T6G 2B7, Canada

Location

Manitoba Health Sciences Centre

Winnipeg, Manitoba, R3A 1R9, Canada

Location

London Health Sciences Centre - UC

London, Ontario, N6A 5A5, Canada

Location

London Health Sciences Centre - VC

London, Ontario, N6B1B1, Canada

Location

Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

Sunnybrook and Women's College HSC

Toronto, Ontario, M4N3M5, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B1W8, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5G2C4, Canada

Location

Vancouver General Hospital

Vancouver, Ontario, V5Z1C6, Canada

Location

Laval Hospital

Laval, Quebec, G1V4G5, Canada

Location

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

Montreal Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Waikato Hospital

Hamilton, New Zealand

Location

Related Publications (6)

  • Fremes SE. Multicenter radial artery patency study (RAPS). Study design. Control Clin Trials. 2000 Aug;21(4):397-413. doi: 10.1016/s0197-2456(00)00059-3.

    PMID: 10913815BACKGROUND

  • Desai ND, Cohen EA, Naylor CD, Fremes SE; Radial Artery Patency Study Investigators. A randomized comparison of radial-artery and saphenous-vein coronary bypass grafts. N Engl J Med. 2004 Nov 25;351(22):2302-9. doi: 10.1056/NEJMoa040982.

    PMID: 15564545RESULT

  • Deb S, Cohen EA, Singh SK, Une D, Laupacis A, Fremes SE; RAPS Investigators. Radial artery and saphenous vein patency more than 5 years after coronary artery bypass surgery: results from RAPS (Radial Artery Patency Study). J Am Coll Cardiol. 2012 Jul 3;60(1):28-35. doi: 10.1016/j.jacc.2012.03.037.

    PMID: 22742399RESULT

  • Tam DY, Deb S, Nguyen B, Ko DT, Karkhanis R, Moussa F, Fremes J, Cohen EA, Radhakrishnan S, Fremes SE. The radial artery is protective in women and men following coronary artery bypass grafting-a substudy of the radial artery patency study. Ann Cardiothorac Surg. 2018 Jul;7(4):492-499. doi: 10.21037/acs.2018.05.19.

    PMID: 30094213DERIVED

  • Deb S, Singh SK, Moussa F, Tsubota H, Une D, Kiss A, Tomlinson G, Afshar M, Sless R, Cohen EA, Radhakrishnan S, Dubbin J, Schwartz L, Fremes SE; Radial Artery Patency Study Investigators. The long-term impact of diabetes on graft patency after coronary artery bypass grafting surgery: a substudy of the multicenter Radial Artery Patency Study. J Thorac Cardiovasc Surg. 2014 Oct;148(4):1246-53; discussion 1253. doi: 10.1016/j.jtcvs.2014.06.057. Epub 2014 Jul 17.

    PMID: 25109754DERIVED

  • Yanagawa B, Algarni KD, Singh SK, Deb S, Vincent J, Elituv R, Desai ND, Rajamani K, McManus BM, Liu PP, Cohen EA, Radhakrishnan S, Dubbin JD, Schwartz L, Fremes SE. Clinical, biochemical, and genetic predictors of coronary artery bypass graft failure. J Thorac Cardiovasc Surg. 2014 Aug;148(2):515-520.e2. doi: 10.1016/j.jtcvs.2013.10.011. Epub 2013 Dec 9.

    PMID: 24332189DERIVED

Related Links

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Stephen E Fremes, MD

    Sunnybrook Health Sciences Centre

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head, Division of Cardiac and Vascular Surgery and Dr. Bernard S. Goldman Chair in Cardiovascular Surgery

Study Record Dates

First Submitted

September 10, 2005

First Posted

September 16, 2005

Study Start

July 1, 2002

Primary Completion

September 1, 2010

Study Completion

October 1, 2010

Last Updated

June 5, 2013

Record last verified: 2013-06

Locations

CA(12)NZ(1)