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

Primary Purpose

Coronary Artery Disease

Status
Withdrawn
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Coronary artery bypass (CABG) surgery using a radial arterial conduit
Coronary artery bypass surgery using a long saphenous vein conduit
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary artery bypass surgery, Arteries, Veins, Conduits

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Royal Brompton & Harefield NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Radial artery

Long saphenous vein

Arm Description

Use of the radial artery as a conduit in CABG surgery

Use of long saphenous vein as a conduit in CABG surgery

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Angiographic visual grading
Compare secondary angiographic visual grading in radial artery and long saphenous vein grafts
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

Full Information

First Posted
March 22, 2012
Last Updated
February 27, 2019
Sponsor
Imperial College London
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1. Study Identification

Unique Protocol Identification Number
NCT01622387
Brief Title
Radial Artery Versus Saphenous Vein Patency (RSVP) Trial - 10 Year Follow-up
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Withdrawn
Why Stopped
No funding
Study Start Date
October 13, 2011 (Actual)
Primary Completion Date
July 3, 2014 (Actual)
Study Completion Date
July 3, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary artery bypass surgery, Arteries, Veins, Conduits

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Radial artery
Arm Type
Experimental
Arm Description
Use of the radial artery as a conduit in CABG surgery
Arm Title
Long saphenous vein
Arm Type
Active Comparator
Arm Description
Use of long saphenous vein as a conduit in CABG surgery
Intervention Type
Procedure
Intervention Name(s)
Coronary artery bypass (CABG) surgery using a radial arterial conduit
Intervention Description
Use of radial artery as a bypass conduit/graft to the left circumflex coronary artery region of the heart in CABG surgery
Intervention Type
Procedure
Intervention Name(s)
Coronary artery bypass surgery using a long saphenous vein conduit
Intervention Description
Use of long saphenous vein as a graft/conduit vessel to the left circumflex coronary artery region of the heart in CABG surgery
Primary Outcome Measure Information:
Title
Proportion of radial artery and saphenous vein grafts patent at 10 years
Description
Comparison of the patency of radial artery and long saphenous aorto-coronary bypass grafts at 10 years, assessed by an independent observer
Time Frame
10 years post surgery
Secondary Outcome Measure Information:
Title
Angiographic visual grading
Description
Compare secondary angiographic visual grading in radial artery and long saphenous vein grafts
Time Frame
10 years post surgery
Title
Patency (patent or complete occlusion, and secondary visual grading) of radial artery and internal mammary artery coronary bypass grafts
Description
Compare the patency (patent or complete occlusion, and secondary visual grading) of radial artery and internal mammary artery coronary bypass grafts
Time Frame
10 years post surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Collins, MA, MD, FRCP
Organizational Affiliation
Imperial College London, and RBHFT
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Neil Moat, MD, FRCS
Organizational Affiliation
Royal Brompton & Harefield NHS Foundation Trust
Official's Role
Study Director
Facility Information:
Facility Name
Royal Brompton & Harefield NHS Foundation Trust
City
London
ZIP/Postal Code
SW3 6NP
Country
United Kingdom

12. IPD Sharing Statement

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

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