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NCT01622387 Clinical Trial

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

Coronary Artery Disease Clinical Trial

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 (RSVP Trial) - 10-year Follow-up

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01622387
Other study ID # P38558
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date October 13, 2011
Est. completion date July 3, 2014

Study information
Verified date August 2015
Source Imperial College London
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date July 3, 2014
Est. primary completion date July 3, 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Coronary artery bypass (CABG) 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
• 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

Locations
Country Name City State
United Kingdom Royal Brompton & Harefield NHS Foundation Trust London

Sponsors (1)
Lead Sponsor Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Angiographic visual grading Compare secondary angiographic visual grading in radial artery and long saphenous vein grafts 10 years post surgery
Secondary Patency (patent or complete occlusion, and secondary visual grading) of radial artery and internal mammary artery coronary bypass grafts Compare the patency (patent or complete occlusion, and secondary visual grading) of radial artery and internal mammary artery coronary bypass grafts 10 years post surgery
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