NCT00139399

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 1998

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1998

Completed
7.3 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 31, 2005

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
12.6 years until next milestone

Results Posted

Study results publicly available

June 10, 2019

Completed
Last Updated

June 25, 2019

Status Verified

June 1, 2019

Enrollment Period

8.2 years

First QC Date

August 30, 2005

Results QC Date

March 6, 2019

Last Update Submit

June 17, 2019

Conditions

Coronary Arteriosclerosis

Keywords

Coronary artery bypassCoronary arteriesAtherosclerosisAngiographyBlood flow

Outcome Measures

Primary Outcomes (2)

  • Patency Rates

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

    5 years

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

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

    5 year follow-up

Secondary Outcomes (1)

  • Blood Flow Volume

    5 years

Study Arms (2)

Saphenous vein

ACTIVE COMPARATOR

Saphenous vein aortocoronary bypass graft

Procedure: Coronary artery bypass graft (CABG) surgery

Radial artery

EXPERIMENTAL

Radial artery aortocoronary bypass graft

Procedure: Coronary artery bypass graft (CABG) surgery

Interventions

Coronary artery bypass graft (CABG) surgeryPROCEDURE

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 arterySaphenous vein

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Brompton & Harefield NHS Trust

London, SW3 6NP, United Kingdom

Location

Related Publications (3)

  • 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.

    PMID: 18506009RESULT

  • 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.

    PMID: 16722590RESULT

  • 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.

    PMID: 20713903RESULT

MeSH Terms

Conditions

Coronary Artery DiseaseAtherosclerosis

Interventions

Coronary Artery BypassSurgical Procedures, Operative

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Myocardial RevascularizationCardiac Surgical ProceduresCardiovascular Surgical ProceduresVascular GraftingVascular Surgical ProceduresThoracic Surgical Procedures

Results Point of Contact

Title
Dr Carolyn Webb
Organization
Imperial College London
c.webb@imperial.ac.uk
03301288860

Study Officials

  • Neil E Moat, MS, FRCS

    Royal Brompton & Harefield NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2005

First Posted

August 31, 2005

Study Start

May 1, 1998

Primary Completion

July 1, 2006

Study Completion

November 1, 2006

Last Updated

June 25, 2019

Results First Posted

June 10, 2019

Record last verified: 2019-06

Locations

GB(1)