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Completed

NCT Number: NCT00139399

Radial Artery Versus Saphenous Vein Patency (RSVP) Study

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.

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Key information

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Royal Brompton & Harefield NHS Trust

London, SW3 6NP, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coronary artery bypass graft (CABG) surgery

Procedure

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 outcomes

  1. Patency Rates

    Time frame: 5 years

    Angiographic patency rates of radial artery and long saphenous vein grafts at follow-up angiography

  2. Mean Diameter of the Study Graft (Saphenous Vein or Radial Artery)

    Time frame: 5 year follow-up

    Diameter response of the study vessel (saphenous vein or radial artery graft) to acetylcholine, measured using quantitative coronary angiography from the coronary angiogram.

Secondary outcomes

  1. Blood Flow Volume

    Time frame: 5 years

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

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • National Heart Foundation, Australia
  • Royal Brompton & Harefield NHS Foundation Trust
  • The Royal College of Surgeons of England
  • Victor Phillip Dahdaleh Charitable Foundation

Registry information

Official study title

A Randomised Controlled Trial to Compare Angiographic Patency of Radial Artery Versus Saphenous Vein Used as Free Aorto-coronary Grafts in Coronary Revascularization

Acronym: RSVP

Important dates

Study start
1998
Primary completion
2006
Study completion
2006
First posted
Aug 31, 2005
Registry last updated
Jun 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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