Radial Artery Versus Saphenous Vein Patency (RSVP) Study

This study has been completed.
Sponsor:
Collaborators:
The Royal College of Surgeons of England
Royal Brompton & Harefield NHS Foundation Trust
National Heart Foundation, Australia
Victor Phillip Dahdaleh Charitable Foundation
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT00139399
First received: August 30, 2005
Last updated: October 19, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Coronary Arteriosclerosis
Procedure: Coronary artery bypass surgery
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial to Compare Angiographic Patency of Radial Artery Versus Saphenous Vein Used as Free Aorto-coronary Grafts in Coronary Revascularisation

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Angiographic patency rates of radial artery and long saphenous vein grafts to the native left circumflex territory [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety/efficacy assessment [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Physiological assessment of the randomized graft at angiography [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 142
Study Start Date: May 1998
Study Completion Date: November 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Saphenous vein coronary artery bypass graft
Radial artery coronary artery bypass graft versus active comparator of long saphenous vein coronary artery bypass graft
Procedure: Coronary artery bypass surgery
Radial artery versus long saphenous vein grafted to the left circumflex coronary artery territory during CABG surgery
Other Name: CABG surgery
Experimental: Radial artery coronary artery bypass graft Procedure: Coronary artery bypass surgery
Radial artery versus long saphenous vein grafted to the left circumflex coronary artery territory during CABG surgery
Other Name: CABG 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.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 LV function (EF <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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00139399

Locations
United Kingdom
Royal Brompton & Harefield NHS Trust
London, United Kingdom, SW3 6NP
Sponsors and Collaborators
Imperial College London
The Royal College of Surgeons of England
Royal Brompton & Harefield NHS Foundation Trust
National Heart Foundation, Australia
Victor Phillip Dahdaleh Charitable Foundation
Investigators
Principal Investigator: Neil E Moat, MS, FRCS Royal Brompton & Harefield NHS Foundation Trust
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00139399     History of Changes
Other Study ID Numbers: LREC 98-010
Study First Received: August 30, 2005
Last Updated: October 19, 2011
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Imperial College London:
Coronary artery bypass
Coronary arteries
Atherosclerosis
Angiography
Blood flow

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Coronary Artery Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases

ClinicalTrials.gov processed this record on August 19, 2014