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Radial Artery Versus Saphenous Vein Patency (RSVP) Study (RSVP)

Primary Purpose

Coronary Arteriosclerosis

Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Coronary artery bypass graft (CABG) surgery
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Arteriosclerosis focused on measuring Coronary artery bypass, Coronary arteries, Atherosclerosis, Angiography, Blood flow

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: on waiting list for clinically-indicated myocardial revascularization surgery aged 40-70 years significant stenosis (≥70%) in the circumflex territory as identified on preoperative angiograms negative Allen's test (defined as the return of palmar circulation within 5 seconds of releasing ulnar artery compression) willing to give written informed consent Exclusion Criteria: poor left ventricular (LV) function (LV ejection fraction <25%) severe diffuse peripheral vascular disease or bilateral varicose venous disease inability to comply with the angiographic follow-up at 3 months or/and 5 years

Sites / Locations

  • Royal Brompton & Harefield NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Saphenous vein

Radial artery

Arm Description

Saphenous vein aortocoronary bypass graft

Radial artery aortocoronary bypass graft

Outcomes

Primary Outcome Measures

Patency Rates
Angiographic patency rates of radial artery and long saphenous vein grafts at follow-up angiography
Mean Diameter of the Study Graft (Saphenous Vein or Radial Artery)
Diameter response of the study vessel (saphenous vein or radial artery graft) to acetylcholine, measured using quantitative coronary angiography from the coronary angiogram.

Secondary Outcome Measures

Blood Flow Volume
Graft flow response to acetylcholine, calculated from vessel diameter using quantitative coronary angiography, and velocity using an intragraft Doppler wire.

Full Information

First Posted
August 30, 2005
Last Updated
June 17, 2019
Sponsor
Imperial College London
Collaborators
The Royal College of Surgeons of England, Royal Brompton & Harefield NHS Foundation Trust, National Heart Foundation, Australia, Victor Phillip Dahdaleh Charitable Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00139399
Brief Title
Radial Artery Versus Saphenous Vein Patency (RSVP) Study
Acronym
RSVP
Official Title
A Randomised Controlled Trial to Compare Angiographic Patency of Radial Artery Versus Saphenous Vein Used as Free Aorto-coronary Grafts in Coronary Revascularization
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
May 1998 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
November 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
Collaborators
The Royal College of Surgeons of England, Royal Brompton & Harefield NHS Foundation Trust, National Heart Foundation, Australia, Victor Phillip Dahdaleh Charitable Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether the radial artery (artery in the arm) or saphenous vein (vein in the leg), when used as bypass grafts for coronary artery bypass surgery, have a greater patency rate (degree of opening)at 5 years after surgery.
Detailed Description
Arteries differ from veins both in morphology and physiology. Thus the way they behave as in vivo conduits when used in coronary artery bypass grafting is also likely to be different. This may partly explain the predisposition of veins used as coronary conduits to accelerated atherosclerosis in comparison with the internal mammary artery grafts. There are presently few data describing the properties of the radial artery as an in-vivo coronary conduit over the longer-term. The study will compare angiographic patency of the radial artery or saphenous vein graft anastomosed to the native left circumflex coronary territory at 3 months and 5 years after surgery. A substudy will compare 5-year post-surgery diameter and blood flow of in-vivo radial artery and saphenous vein grafts in response to endothelium-dependent and non-endothelium-dependent stimuli when patients attend for their scheduled follow-up angiogram.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Arteriosclerosis
Keywords
Coronary artery bypass, Coronary arteries, Atherosclerosis, Angiography, Blood flow

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
142 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Saphenous vein
Arm Type
Active Comparator
Arm Description
Saphenous vein aortocoronary bypass graft
Arm Title
Radial artery
Arm Type
Experimental
Arm Description
Radial artery aortocoronary bypass graft
Intervention Type
Procedure
Intervention Name(s)
Coronary artery bypass graft (CABG) surgery
Intervention Description
Patients were randomized to receive either a radial artery or a long saphenous vein graft to the left circumflex coronary artery territory during CABG surgery
Primary Outcome Measure Information:
Title
Patency Rates
Description
Angiographic patency rates of radial artery and long saphenous vein grafts at follow-up angiography
Time Frame
5 years
Title
Mean Diameter of the Study Graft (Saphenous Vein or Radial Artery)
Description
Diameter response of the study vessel (saphenous vein or radial artery graft) to acetylcholine, measured using quantitative coronary angiography from the coronary angiogram.
Time Frame
5 year follow-up
Secondary Outcome Measure Information:
Title
Blood Flow Volume
Description
Graft flow response to acetylcholine, calculated from vessel diameter using quantitative coronary angiography, and velocity using an intragraft Doppler wire.
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: on waiting list for clinically-indicated myocardial revascularization surgery aged 40-70 years significant stenosis (≥70%) in the circumflex territory as identified on preoperative angiograms negative Allen's test (defined as the return of palmar circulation within 5 seconds of releasing ulnar artery compression) willing to give written informed consent Exclusion Criteria: poor left ventricular (LV) function (LV ejection fraction <25%) severe diffuse peripheral vascular disease or bilateral varicose venous disease inability to comply with the angiographic follow-up at 3 months or/and 5 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil E Moat, MS, FRCS
Organizational Affiliation
Royal Brompton & Harefield NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Brompton & Harefield NHS Trust
City
London
ZIP/Postal Code
SW3 6NP
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
18506009
Citation
Collins P, Webb CM, Chong CF, Moat NE; Radial Artery Versus Saphenous Vein Patency (RSVP) Trial Investigators. Radial artery versus saphenous vein patency randomized trial: five-year angiographic follow-up. Circulation. 2008 Jun 3;117(22):2859-64. doi: 10.1161/CIRCULATIONAHA.107.736215. Epub 2008 May 27.
Results Reference
result
PubMed Identifier
16722590
Citation
Chong WC, Collins P, Webb CM, De Souza AC, Pepper JR, Hayward CS, Moat NE. Comparison of flow characteristics and vascular reactivity of radial artery and long saphenous vein grafts [NCT00139399]. J Cardiothorac Surg. 2006 Mar 3;1:4. doi: 10.1186/1749-8090-1-4.
Results Reference
result
PubMed Identifier
20713903
Citation
Webb CM, Moat NE, Chong CF, Collins P. Vascular reactivity and flow characteristics of radial artery and long saphenous vein coronary bypass grafts: a 5-year follow-up. Circulation. 2010 Aug 31;122(9):861-7. doi: 10.1161/CIRCULATIONAHA.109.887000. Epub 2010 Aug 16.
Results Reference
result

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Radial Artery Versus Saphenous Vein Patency (RSVP) Study

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