Radial Artery Versus Saphenous Vein Patency (RSVP) Study - Full Text View

Sponsors and Collaborators:	Imperial College London The Royal College of Surgeons of England Royal Brompton Hospital NHS Trust National Heart Foundation, Australia Victor Phillip Dahdaleh Charitable Foundation
Information provided by:	Imperial College London
ClinicalTrials.gov Identifier:	NCT00139399

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 III

MedlinePlus related topics: Coronary Artery Bypass Surgery Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Bio-equivalence Study
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

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
2: Active Comparator 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

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

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 Hospital NHS Trust

National Heart Foundation, Australia

Victor Phillip Dahdaleh Charitable Foundation

Investigators

Principal Investigator:

Neil E Moat, MS, FRCS

Royal Brompton Hospital NHS Trust

More Information

No publications provided by Imperial College London

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Study ID Numbers:	LREC 98-010
Study First Received:	August 30, 2005
Last Updated:	September 9, 2008
ClinicalTrials.gov Identifier:	NCT00139399 History of Changes
Health Authority:	United Kingdom: Research Ethics Committee

Keywords provided by Imperial College London:

Coronary artery bypass
Coronary arteries
Atherosclerosis
Angiography
Blood flow

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Atherosclerosis
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Ischemia
Arteriosclerosis
Coronary Artery Disease

Additional relevant MeSH terms:

Coronary Disease
Arterial Occlusive Diseases
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Coronary Artery Disease

ClinicalTrials.gov processed this record on May 07, 2009