Coronary ArteriosclerosisPhase 3RSVPNCT00139399
Radial Artery Versus Saphenous Vein Patency (RSVP) Study
A Phase 3 study testing Coronary artery bypass graft (CABG) surgery in people with Coronary Arteriosclerosis, run by Imperial College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Coronary Arteriosclerosis
- What is being tested?
- Coronary artery bypass graft (CABG) surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 1998to Nov 2006
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Brompton & Harefield NHS Trust
London, SW3 6NP
About this 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 Revascularization
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.
Read the 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.
- Conditions
- Coronary Arteriosclerosis
- Being tested
- Coronary artery bypass graft (CABG) surgery
- Keywords
- Coronary artery bypass, Coronary arteries, Atherosclerosis, Angiography, Blood flow
- Medical subject headings
- Coronary Artery Disease, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary artery bypass graft (CABG) surgeryProcedure or 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
| Study group | Role | What they receive |
|---|---|---|
| Saphenous vein | Active comparator | Saphenous vein aortocoronary bypass graft Receives: Procedure: Coronary artery bypass graft (CABG) surgery |
| Radial artery | Experimental | Radial artery aortocoronary bypass graft Receives: Procedure: Coronary artery bypass graft (CABG) surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patency Rates
Angiographic patency rates of radial artery and long saphenous vein grafts at follow-up angiography
Measured: 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.
Measured: 5 year follow-up
Secondary outcomes (1)
Blood Flow Volume
Graft flow response to acetylcholine, calculated from vessel diameter using quantitative coronary angiography, and velocity using an intragraft Doppler wire.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2005 (estimated)
- Study startMay 1998
- Primary completionJul 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary ArteriosclerosisStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- The Royal College of Surgeons of England, Royal Brompton & Harefield NHS Foundation Trust, National Heart Foundation, Australia, Victor Phillip Dahdaleh Charitable Foundation
- Responsible party
- Sponsor
- Investigators
- Neil E Moat, MS, FRCS, Principal investigator, Royal Brompton & Harefield NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00139399
- Sponsor's protocol ID
- LREC 98-010
- Acronym
- RSVP
- Status last verified
- Jun 2019
- First submitted
- 30 Aug 2005
- Last updated
- 25 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 18506009Chong 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.
PubMed 16722590Webb 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.
PubMed 20713903
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial to Compare Angiographic Patency of Radial Artery Versus Saphenous Vein Used as Free Aorto-coronary Grafts in Coronary Revascularization
- ClinicalTrials.gov ID
- NCT00139399
- Acronym / sponsor ID
- RSVP / LREC 98-010
- Conditions
- Coronary Arteriosclerosis
- Keywords
- Coronary artery bypass, Coronary arteries, Atherosclerosis, Angiography, Blood flow
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- The Royal College of Surgeons of England, Royal Brompton & Harefield NHS Foundation Trust, National Heart Foundation, Australia, Victor Phillip Dahdaleh Charitable Foundation
- Study start
- May 1998
- Primary completion
- Jul 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 31 Aug 2005 (estimated)
- Results
- Posted 10 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saphenous vein | Active comparator | Procedure: Coronary artery bypass graft (CABG) surgerySaphenous vein aortocoronary bypass graft |
| Radial artery | Experimental | Procedure: Coronary artery bypass graft (CABG) surgeryRadial artery aortocoronary bypass graft |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary artery bypass graft (CABG) surgeryPatients were randomized to receive either a radial artery or a long saphenous vein graft to the left circumflex coronary artery territory during CABG surgery | Procedure or surgery | Radial artery, Saphenous vein |
Primary outcome
Patency Rates
Time frame: 5 years
Angiographic patency rates of radial artery and long saphenous vein grafts at follow-up angiography
Mean Diameter of the Study Graft (Saphenous Vein or Radial Artery)
Time frame: 5 year follow-up
Diameter response of the study vessel (saphenous vein or radial artery graft) to acetylcholine, measured using quantitative coronary angiography from the coronary angiogram.
1 secondary outcome
Blood Flow Volume
Time frame: 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 18506009Collins 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.
- Results publication: PubMed 16722590Chong 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.
- Results publication: PubMed 20713903Webb 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neil E Moat, MS, FRCS principal investigator
Royal Brompton & Harefield NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Coronary artery bypass graft (CABG) surgery in people with Coronary Arteriosclerosis, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patency Rates (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00139399, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2019.