- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01622387
Radial Artery Versus Saphenous Vein Patency (RSVP) Trial - 10 Year Follow-up
February 27, 2019 updated by: Imperial College London
Randomised, Controlled Trial Comparing Angiographic Patency of the Radial Artery Versus the Saphenous Vein Used as Free Aorto-coronary Grafts in Coronary Revascularisation (RSVP Trial) - 10-year Follow-up
During coronary bypass surgery, veins are taken from the leg and applied to the heart and aorta to 'bypass' narrowings in the coronary arteries.
However using an artery in the chest, the internal mammary artery, means that the bypass lasts longer than using veins.
The investigators recently showed that using an artery from the arm as a bypass vessel, the radial artery, also had less furring up than veins 5 years after surgery.
Now the investigators would like to ask patients to come back for an angiogram 10 years following surgery.
Study Overview
Status
Withdrawn
Conditions
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
London, United Kingdom, SW3 6NP
- Royal Brompton & Harefield NHS Foundation Trust
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Included in the RSVP study
- Willing to attend for coronary angiography
- Willing to give written informed consent
Exclusion Criteria:
- Contraindication to coronary angiography
- participation in research project within previous 60 days
- unwilling to give written informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Radial artery
Use of the radial artery as a conduit in CABG surgery
|
Use of radial artery as a bypass conduit/graft to the left circumflex coronary artery region of the heart in CABG surgery
|
ACTIVE_COMPARATOR: Long saphenous vein
Use of long saphenous vein as a conduit in CABG surgery
|
Use of long saphenous vein as a graft/conduit vessel to the left circumflex coronary artery region of the heart in CABG surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of radial artery and saphenous vein grafts patent at 10 years
Time Frame: 10 years post surgery
|
Comparison of the patency of radial artery and long saphenous aorto-coronary bypass grafts at 10 years, assessed by an independent observer
|
10 years post surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Angiographic visual grading
Time Frame: 10 years post surgery
|
Compare secondary angiographic visual grading in radial artery and long saphenous vein grafts
|
10 years post surgery
|
Patency (patent or complete occlusion, and secondary visual grading) of radial artery and internal mammary artery coronary bypass grafts
Time Frame: 10 years post surgery
|
Compare the patency (patent or complete occlusion, and secondary visual grading) of radial artery and internal mammary artery coronary bypass grafts
|
10 years post surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Peter Collins, MA, MD, FRCP, Imperial College London, and RBHFT
- Study Director: Neil Moat, MD, FRCS, Royal Brompton & Harefield NHS Foundation Trust
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 13, 2011
Primary Completion (ACTUAL)
July 3, 2014
Study Completion (ACTUAL)
July 3, 2014
Study Registration Dates
First Submitted
March 22, 2012
First Submitted That Met QC Criteria
June 14, 2012
First Posted (ESTIMATE)
June 19, 2012
Study Record Updates
Last Update Posted (ACTUAL)
March 1, 2019
Last Update Submitted That Met QC Criteria
February 27, 2019
Last Verified
August 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P38558
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Coronary Artery Disease
-
Elixir Medical CorporationIstituto Clinico HumanitasActive, not recruitingCoronary Artery Disease | Chronic Total Occlusion of Coronary Artery | Multi Vessel Coronary Artery Disease | Bifurcation of Coronary Artery | Long Lesions Coronary Artery DiseaseItaly
-
Fundación EPICActive, not recruitingCoronary Artery Disease | Left Main Coronary Artery Disease | Left Main Coronary Artery Stenosis | Restenosis, CoronarySpain
-
Peking Union Medical College HospitalNot yet recruitingCoronary Artery Disease | Inflammation | Coronary Artery Disease Progression | Coronary Artery Stenosis | Coronary Artery Restenosis | Inflammatory Disease | Inflammation VascularChina
-
Peking Union Medical College HospitalRecruitingCoronary Artery Disease | Inflammation | Coronary Artery Disease Progression | Coronary Artery Stenosis | Coronary Artery Restenosis | Inflammatory Disease | Inflammation VascularChina
-
IGLESIAS Juan FernandoUniversity of BernNot yet recruiting
-
National Institutes of Health Clinical Center (CC)National Heart, Lung, and Blood Institute (NHLBI)CompletedCoronary Arteriosclerosis | Coronary Artery Disease (CAD) | Obstructive Coronary Artery DiseaseUnited States
-
Barts & The London NHS TrustImperial College London; Brunel UniversityNot yet recruitingCORONARY ARTERY DISEASE
-
Fundación EPICRecruitingCoronary Artery Disease | Coronary Disease | Coronary Occlusion | Left Main Coronary Artery Disease | Coronary Artery StenosisSpain
-
Abbott Medical DevicesCompletedCoronary Artery Disease | Coronary Disease | Coronary Occlusion | Chronic Total Occlusion of Coronary Artery | Coronary Restenosis | Coronary Artery Stenosis | Coronary Artery RestenosisBelgium
-
China National Center for Cardiovascular DiseasesRecruitingLeft Main Coronary Artery DiseaseChina
Clinical Trials on Coronary artery bypass (CABG) surgery using a radial arterial conduit
-
Imperial College LondonNational Heart Foundation, Australia; Royal Brompton & Harefield NHS Foundation... and other collaboratorsCompletedCoronary ArteriosclerosisUnited Kingdom
-
Prakash PunjabiRecruitingCoronary Artery Disease | Coronary Stenosis | Ischaemic Heart DiseaseUnited Kingdom
-
Ulrik Sartipy, MD, PhDKarolinska InstitutetActive, not recruitingDepression | Cardiovascular Diseases | Kidney Diseases | Diabetes Mellitus
-
University of Sao Paulo General HospitalHospital Israelita Albert Einstein; Instituto Dante Pazzanese de Cardiologia; Beneficência Portuguesa de São Paulo and other collaboratorsCompletedCardiac Surgical ProceduresBrazil
-
Vascular Graft Solutions Ltd.CompletedCoronary Artery DiseaseGermany, Austria, United Kingdom, Israel
-
Medtronic CardiovascularCompletedArteriosclerosis of Coronary Artery Bypass GraftCanada, United States
-
Ajou University School of MedicineActive, not recruitingMyocardial Infarction | Obesity Associated DisorderKorea, Republic of
-
China National Center for Cardiovascular DiseasesUnknownCoronary Artery Disease | Congestive Heart Failure | Ischemic CardiomyopathyChina
-
US Department of Veterans AffairsCompletedCardiovascular DiseaseUnited States
-
University Hospital OstravaPalacky University; Ministry of Health, Czech RepublicCompletedHeart Valve Diseases | Coronary Artery Bypass Graft RedoCzechia