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Radial Artery Versus Saphenous Vein Patency (RSVP) Trial - 10 Year Follow-up

This study is not yet open for participant recruitment.
Verified June 2012 by Imperial College London
Sponsor:
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01622387
First received: March 22, 2012
Last updated: June 14, 2012
Last verified: June 2012
History of Changes
  Purpose

During coronary bypass surgery, veins are taken from the leg and applied to the heart and aorta to 'bypass' narrowings in the coronary arteries. However using an artery in the chest, the internal mammary artery, means that the bypass lasts longer than using veins. The investigators recently showed that using an artery from the arm as a bypass vessel, the radial artery, also had less furring up than veins 5 years after surgery. Now the investigators would like to ask patients to come back for an angiogram 10 years following surgery.


Condition Intervention
Coronary Artery Disease
 Procedure: Coronary artery bypass surgery using a radial arterial conduit
Procedure: Coronary artery bypass surgery using a long saphenous vein conduit

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomised, Controlled Trial Comparing Angiographic Patency of the Radial Artery Versus the Saphenous Vein Used as Free Aorto-coronary Grafts in Coronary Revascularisation (Radial Artery Versus Saphenous Vein Patency (RSVP) Trial) - 10-year Follow-up

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Proportion of radial artery and saphenous vein grafts patent at 10 years [ Time Frame: 10 years post surgery ] [ Designated as safety issue: No ]
    Comparison of the patency of radial artery and long saphenous aorto-coronary bypass grafts at 10 years, assessed by an independent observer


Secondary Outcome Measures:
  • Angiographic visual grading [ Time Frame: 10 years post surgery ] [ Designated as safety issue: No ]
    Compare secondary angiographic visual grading in RA and long SV grafts

  • Patency (patent or complete occlusion, and secondary visual grading) of RA and IMA coronary bypass grafts [ Time Frame: 10 years post surgery ] [ Designated as safety issue: No ]
    Compare the patency (patent or complete occlusion, and secondary visual grading) of RA and IMA coronary bypass grafts


Estimated Enrollment: 106
Study Start Date: June 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Radial artery
Use of the radial artery as a conduit in CABG surgery
 Procedure: Coronary artery bypass surgery using a radial arterial conduit
Use of radial artery as a bypass conduit/graft to the left circumflex coronary artery region of the heart in CABG surgery
Active Comparator: Long saphenous vein
Use of long saphenous vein as a conduit in CABG surgery
 Procedure: Coronary artery bypass surgery using a long saphenous vein conduit
Use of long saphenous vein as a graft/conduit vessel to the left circumflex coronary artery region of the heart in CABG surgery

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Included in the RSVP study
  • Willing to attend for coronary angiography
  • Willing to give written informed consent

Exclusion Criteria:

  • Contraindication to coronary angiography
  • participation in research project within previous 60 days
  • unwilling to give written informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01622387

Locations
United Kingdom
Royal Brompton & Harefield NHS Foundation Trust Not yet recruiting
London, United Kingdom, SW3 6NP
Contact: Carolyn M Webb, PhD     +44 20 7351 8860     c.webb@imperial.ac.uk    
Principal Investigator: Peter Collins, MA, MD, FRCP            
Sub-Investigator: Neil Moat, MD, FRCS            
Sub-Investigator: Carolyn M Webb, PhD            
Sponsors and Collaborators
Imperial College London
Investigators
Principal Investigator: Peter Collins, MA, MD, FRCP Imperial College London, and RBHFT
Study Director: Neil Moat, MD, FRCS Royal Brompton & Harefield NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01622387     History of Changes
Other Study ID Numbers: P38558
Study First Received: March 22, 2012
Last Updated: June 14, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Imperial College London:
Coronary artery bypass surgery
Arteries
Veins
Conduits

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013