Study Stopped
No funding
Radial Artery Versus Saphenous Vein Patency (RSVP) Trial - 10 Year Follow-up
Randomised, Controlled Trial Comparing Angiographic Patency of the Radial Artery Versus the Saphenous Vein Used as Free Aorto-coronary Grafts in Coronary Revascularisation (RSVP Trial) - 10-year Follow-up
1 other identifier
interventional
N/A
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
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Started Oct 2011
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 13, 2011
CompletedFirst Submitted
Initial submission to the registry
March 22, 2012
CompletedFirst Posted
Study publicly available on registry
June 19, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 3, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 3, 2014
CompletedMarch 1, 2019
August 1, 2015
2.7 years
March 22, 2012
February 27, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of radial artery and saphenous vein grafts patent at 10 years
Comparison of the patency of radial artery and long saphenous aorto-coronary bypass grafts at 10 years, assessed by an independent observer
10 years post surgery
Secondary Outcomes (2)
Angiographic visual grading
10 years post surgery
Patency (patent or complete occlusion, and secondary visual grading) of radial artery and internal mammary artery coronary bypass grafts
10 years post surgery
Study Arms (2)
Radial artery
EXPERIMENTALUse of the radial artery as a conduit in CABG surgery
Long saphenous vein
ACTIVE COMPARATORUse of long saphenous vein as a conduit in CABG surgery
Interventions
Use of radial artery as a bypass conduit/graft to the left circumflex coronary artery region of the heart in CABG surgery
Use of long saphenous vein as a graft/conduit vessel to the left circumflex coronary artery region of the heart in CABG surgery
Eligibility Criteria
You may qualify if:
- Included in the RSVP study
- Willing to attend for coronary angiography
- Willing to give written informed consent
You may not qualify if:
- Contraindication to coronary angiography
- participation in research project within previous 60 days
- unwilling to give written informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Royal Brompton & Harefield NHS Foundation Trust
London, SW3 6NP, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Collins, MA, MD, FRCP
Imperial College London, and RBHFT
- STUDY DIRECTOR
Neil Moat, MD, FRCS
Royal Brompton & Harefield NHS Foundation Trust
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2012
First Posted
June 19, 2012
Study Start
October 13, 2011
Primary Completion
July 3, 2014
Study Completion
July 3, 2014
Last Updated
March 1, 2019
Record last verified: 2015-08