Coronary Artery DiseaseNCT01622387
Radial Artery Versus Saphenous Vein Patency (RSVP) Trial - 10 Year Follow-up
A study testing Coronary artery bypass (CABG) surgery using a radial arterial conduit and Coronary artery bypass surgery using a long saphenous vein conduit in people with Coronary Artery Disease, run by Imperial College London at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Coronary artery bypass (CABG) surgery using a radial arterial conduit and Coronary artery bypass surgery using a long saphenous vein conduit
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Oct 2011to 3 Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Included in the RSVP study
- Willing to attend for coronary angiography
- Willing to give written informed consent
Who cannot join
- Contraindication to coronary angiography
- participation in research project within previous 60 days
- unwilling to give written informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Brompton & Harefield NHS Foundation Trust
London, SW3 6NP
About this study
Official title: 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Coronary artery bypass (CABG) surgery using a radial arterial conduit, Coronary artery bypass surgery using a long saphenous vein conduit
- Keywords
- Coronary artery bypass surgery, Arteries, Veins, Conduits
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary artery bypass (CABG) surgery using a radial arterial conduitProcedure or surgery
Use of radial artery as a bypass conduit/graft to the left circumflex coronary artery region of the heart in CABG surgery
Coronary artery bypass surgery using a long saphenous vein conduitProcedure or surgery
Use of long saphenous vein as a graft/conduit vessel to the left circumflex coronary artery region of the heart in CABG surgery
| Study group | Role | What they receive |
|---|---|---|
| Radial artery | Experimental | Use of the radial artery as a conduit in CABG surgery Receives: Procedure: Coronary artery bypass (CABG) surgery using a radial arterial conduit |
| Long saphenous vein | Active comparator | Use of long saphenous vein as a conduit in CABG surgery Receives: Procedure: Coronary artery bypass surgery using a long saphenous vein conduit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of radial artery and saphenous vein grafts patent at 10 years
Comparison of the patency of radial artery and long saphenous aorto-coronary bypass grafts at 10 years, assessed by an independent observer
Measured: 10 years post surgery
Secondary outcomes (2)
Angiographic visual grading
Compare secondary angiographic visual grading in radial artery and long saphenous vein grafts
Measured: 10 years post surgery
Patency (patent or complete occlusion, and secondary visual grading) of radial artery and internal mammary artery coronary bypass grafts
Compare the patency (patent or complete occlusion, and secondary visual grading) of radial artery and internal mammary artery coronary bypass grafts
Measured: 10 years post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2012 (estimated)
- Study start13 Oct 2011
- Primary completion3 Jul 2014
- Study completion3 Jul 2014
Why it stopped: No funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Collins, MA, MD, FRCP, Principal investigator, Imperial College London, and RBHFTNeil Moat, MD, FRCS, Study director, Royal Brompton & Harefield NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01622387
- Sponsor's protocol ID
- P38558
- Status last verified
- Aug 2015
- First submitted
- 22 Mar 2012
- Last updated
- 1 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01622387
- Acronym / sponsor ID
- P38558
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery bypass surgery, Arteries, Veins, Conduits
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 13 Oct 2011 (actual)
- Primary completion
- 3 Jul 2014 (actual)
- Study completion
- 3 Jul 2014 (actual)
- First posted
- 19 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radial artery | Experimental | Procedure: Coronary artery bypass (CABG) surgery using a radial arterial conduitUse of the radial artery as a conduit in CABG surgery |
| Long saphenous vein | Active comparator | Procedure: Coronary artery bypass surgery using a long saphenous vein conduitUse of long saphenous vein as a conduit in CABG surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Included in the RSVP study
- Willing to attend for coronary angiography
- Willing to give written informed consent
Key exclusion criteria (3 listed)
- Contraindication to coronary angiography
- participation in research project within previous 60 days
- unwilling to give written informed consent
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 (CABG) surgery using a radial arterial conduitUse of radial artery as a bypass conduit/graft to the left circumflex coronary artery region of the heart in CABG surgery | Procedure or surgery | Radial artery |
| Coronary artery bypass surgery using a long saphenous vein conduitUse of long saphenous vein as a graft/conduit vessel to the left circumflex coronary artery region of the heart in CABG surgery | Procedure or surgery | Long saphenous vein |
Primary outcome
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
2 secondary outcomes
Angiographic visual grading
Time frame: 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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2019.
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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.
Peter Collins, MA, MD, FRCP principal investigator
Imperial College London, and RBHFT
Neil Moat, MD, FRCS study director
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 study testing Coronary artery bypass (CABG) surgery using a radial arterial conduit and Coronary artery bypass surgery using a long saphenous vein conduit in people with Coronary Artery Disease, 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 3 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: withdrawn, as of the sponsor's last update on 1 Mar 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Proportion of radial artery and saphenous vein grafts patent at 10 years (time frame: 10 years post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Mar 2019.