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

February 27, 2019 updated by: Imperial College London

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SW3 6NP
        • Royal Brompton & Harefield NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Radial artery
Use of the radial artery as a conduit in CABG surgery
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of radial artery and saphenous vein grafts patent at 10 years
Time Frame: 10 years post surgery
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Angiographic visual grading
Time Frame: 10 years post surgery
Compare secondary angiographic visual grading in radial artery and long saphenous vein grafts
10 years post surgery
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 13, 2011

Primary Completion (ACTUAL)

July 3, 2014

Study Completion (ACTUAL)

July 3, 2014

Study Registration Dates

First Submitted

March 22, 2012

First Submitted That Met QC Criteria

June 14, 2012

First Posted (ESTIMATE)

June 19, 2012

Study Record Updates

Last Update Posted (ACTUAL)

March 1, 2019

Last Update Submitted That Met QC Criteria

February 27, 2019

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P38558

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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