Radial Artery Versus Saphenous Vein Patency (RSVP) Study

NCT ID: NCT00139399

Last Updated: 2019-06-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-05-31

Study Completion Date

2006-11-30

Brief Summary

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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

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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.

Conditions

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Coronary Arteriosclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Saphenous vein

Saphenous vein aortocoronary bypass graft

Group Type ACTIVE_COMPARATOR

Coronary artery bypass graft (CABG) surgery

Intervention Type 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

Radial artery

Radial artery aortocoronary bypass graft

Group Type EXPERIMENTAL

Coronary artery bypass graft (CABG) surgery

Intervention Type 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

Interventions

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Coronary artery bypass graft (CABG) surgery

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Royal College of Surgeons of England

OTHER

Sponsor Role collaborator

Royal Brompton & Harefield NHS Foundation Trust

OTHER

Sponsor Role collaborator

National Heart Foundation, Australia

OTHER

Sponsor Role collaborator

Victor Phillip Dahdaleh Charitable Foundation

OTHER

Sponsor Role collaborator

Imperial College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Neil E Moat, MS, FRCS

Role: PRINCIPAL_INVESTIGATOR

Royal Brompton & Harefield NHS Foundation Trust

Locations

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Royal Brompton & Harefield NHS Trust

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type RESULT
PMID: 18506009 (View on PubMed)

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.

Reference Type RESULT
PMID: 16722590 (View on PubMed)

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.

Reference Type RESULT
PMID: 20713903 (View on PubMed)

Other Identifiers

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LREC 98-010

Identifier Type: -

Identifier Source: org_study_id

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