Cardiovascular DiseaseNCT00054847
Radial Artery Versus Saphenous Vein Grafts in Coronary Artery Bypass Surgery
A study testing saphenous vein graft and radial artery graft in people with Cardiovascular Disease and Coronary Artery Disease, run by US Department of Veterans Affairs at 11 sites in United States.
Trial summary
VA patients with coronary artery disease and who have agreed to undergo coronary artery bypass graft surgery would be randomized to receive either radial artery or saphenous vein to the study vessel. The primary outcome variable is graft patency at one year. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Disease, Coronary Artery Disease
- What is being tested?
- saphenous vein graft and radial artery graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 733 participants
- Where
- 11 sitesUnited States
- Study dates
- Feb 2003to Feb 2010
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients needing coronary artery bypass grafts.
Who cannot join
- Patients who require only a single vessel bypass and in whom the internal mammary artery will be used for that graft
- Patients with previous stripping and ligation of saphenous veins and in whom no venous conduit is available for bypass
- Patients with Raynaud's symptoms
- Patients who have a creatinine above 2.0 mg/dL or require hemodialysis
- Patients with a positive Allen test
- Patients with cardiogenic shock
Show all 17Show fewer
- Patients who are unable to give consent
- Patients allergic to contrast material
- Patients undergoing repeat CABG or any form of robotic surgery
- Patients who do not have full use of both arms
- Patients who are pregnant
- Patients with neurologic or musculoskeletal disease affecting the arm
- Patients who refuse to participate
- Patient requires any concomitant valve operation in the mitral, aortic, or pulmonary position. Isolated tricuspid annuloplasty is acceptable, but tricuspid valve replacement excludes the patient from consideration.
- Patient requires concomitant Dor or Maze procedure
- Patient is in another research study
- No suitable radial target (there is no non-LAD vessel with a >70% stenosis)
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
New Mexico VA Health Care System, Albuquerque
Albuquerque, New Mexico, 87108-5153
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, 48113
VA Medical Center, Birmingham
Birmingham, Alabama, 35233
VA Boston Healthcare System, Brockton Campus
Brockton, Massachusetts, 02301
Edward Hines, Jr. VA Hospital
Hines, Illinois, 60141-5000
Michael E. DeBakey VA Medical Center (152)
Houston, Texas, 77030
VA Medical Center, Minneapolis
Minneapolis, Minnesota, 55417
Southeast Veterans Healthcare System, New Orleans
New Orleans, Louisiana, 70112
Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
No. Little Rock, Arkansas, 72114-1706
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, 23249
Southern Arizona VA Health Care System
Tucson, Arizona, 85723
About this study
Official title: CSP #474 - Radial Artery vs. Saphenous Vein Grafts in Coronary Artery Bypass Surgery (Radial Artery)
VA patients with coronary artery disease and who have agreed to undergo coronary artery bypass graft surgery would be randomized to receive either radial artery or saphenous vein to the study vessel. The primary outcome variable is graft patency at one year.
Read the detailed description
Primary Hypothesis:
Radial artery grafts will have a higher graft patency rate at one year after coronary artery bypass graft surgery (CABG) compared to saphenous vein grafts.
Secondary Hypotheses:
Determine if there are any differences in clinical outcomes, cost and quality of life in patients receiving radial artery versus saphenous vein grafts.
Intervention: 1) Saphenous vein graft. This is the standard conduit for coronary artery bypass grafting to all areas of the heart except the left anterior descending (LAD) artery. 2) Radial artery. This is the experimental conduit. Preference should be given to harvesting from the non-dominant arm.
Primary Outcomes: 1-year post CABG surgery patency rates
Study Abstract:
Although the radial artery was introduced as a potential conduit for coronary artery bypass grafting in the 1970s, enthusiasm for its use was limited by the technical difficulty of harvesting the vessel and problems with perioperative vascular spasm. In spite of this, some surgeons persisted based on their belief that arterial conduits would be better than vein grafts, in terms of long-term patency. With the development of new harvesting techniques and the introduction of calcium channel blockers to prevent vasospasm, the use of the radial artery graft has increased in recent years. This use of the radial artery as a conduit is not based on any long-term prospective data regarding its patency. However, because the VA has been a leader in defining the long-term efficacy/patency of saphenous vein and internal mammary grafts, it is appropriate for the VA to investigate radial artery grafts. In fact, the VA under its Cooperative Studies Program, is probably the only health care delivery system that has the ability to undertake this study.
Study Design:
The study is a prospective, randomized, unblinded clinical trial. The population consists of VA patients with coronary artery disease documented by coronary arteriography and who have agreed to undergo coronary artery bypass surgery. Medical conditions which could affect blood flow through the patient's arm are the main exclusion criteria. These include Raynaud's symptoms, positive Allen test, neurologic or musculoskeletal disease affecting the arm and patients with one arm.
Patients who are eligible and agree to participate in the study will be randomly assigned to receive one radial artery graft or one saphenous vein graft to the following vessels: left anterior descending if internal mammary not used, circumflex, diagonal, and right coronary artery. The surgeon will determine the subject vessel preoperatively by selecting the vessel that is suitable for grafting.
The stratification factors will be the participating hospital and which vessel is to be bypassed, left anterior descending versus all other vessels.
History, physical examination, laboratory tests, and cardiac catheterization will be performed at baseline and at one year. Follow-up clinic visits will be at two weeks, three, six, and nine months post CABG. Coronary angiography will be performed one week and one year post surgery. Quality of life and hand/leg functional status will be assessed at baseline, three months, and one year. Cost measures will be captured.
Biostatistical Considerations:
For this trial, a sample size of 874 randomized patients will be required. This will provide 90% power to detect a difference in one-year patency rates of 92% for the radial artery versus 83% for the saphenous vein and an expected one-year catheter completion rate of 65%.
This is a five year study. There will be four years of patient accrual and one year of follow-up. Nine participating VA medical centers will be expected to randomize two patients per month.
- Conditions
- Cardiovascular Disease, Coronary Artery Disease
- Being tested
- saphenous vein graft, radial artery graft
- Keywords
- CABG, cardiovascular, chronic diseases, clinical trial, heart, multi-site trial, prospective
- Medical subject headings
- Cardiovascular Diseases, Coronary Artery Disease, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
saphenous vein graftProcedure or surgery
Saphenous vein harvested from the arm is used as a conduit for CABG.
radial artery graftProcedure or surgery
Radial artery harvested from the arm is used as a conduit for CABG.
| Study group | Role | What they receive |
|---|---|---|
| Saphenous Vein Graft | Active comparator | Saphenous Vein Graft Receives: Procedure: saphenous vein graft |
| Radial Artery Graft | Active comparator | Radial Artery Graft Receives: Procedure: radial artery graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Compare 1-year Angiographic Patency of Radial Artery Grafts Versus Saphenous Vein Grafts in Patients Undergoing Elective Coronary Artery Bypass Graft (CABG) Surgery.
The primary end point was angiographic graft patency at 1 year after coronary artery bypass surgery, defined as any opacification of distal target by injection of the graft. The window for the 1-year angiogram was 2 to 24 months. This window was chosen to capture early clinically indicated angiograms and late selective angiograms in patients who did not have symptoms. Study grafts that were occluded at 1 week after coronary artery bypass graft surgery were considered occluded at 1 year. One-year graft patency data were missing if patients whose study grafts were patent at 1 week did not undergo an angiogram within the time window or if the central angiography laboratory was not able to determine graft patency.
Measured: 1 year
Secondary outcomes (3)
Death
Measured: Within 1 year of surgery.
Myocardial Infarction
Measured: Within 1 year of bypass surgery
Stroke
Measured: Within 1 year of bypass surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2003 (estimated)
- Study startFeb 2003
- Primary completionFeb 2009
- Study completionFeb 2010
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 (10)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 733 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Steven Goldman, MD, Study chair, Southern Arizona VA Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00054847
- Sponsor's protocol ID
- 474
- Status last verified
- Apr 2014
- First submitted
- 11 Feb 2003
- Last updated
- 5 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Mudumbai SC, Wagner T, Mahajan S, King R, Heidenreich PA, Hlatky M, Wallace A, Mariano ER. Vascular surgery patients prescribed preoperative beta-blockers experienced a decrease in the maximal heart rate observed during induction of general anesthesia. J Cardiothorac Vasc Anesth. 2012 Jun;26(3):414-9. doi: 10.1053/j.jvca.2011.09.027. Epub 2011 Dec 3.
PubMed 22138312Sinnott PL, Siroka AM, Shane AC, Trafton JA, Wagner TH. Identifying neck and back pain in administrative data: defining the right cohort. Spine (Phila Pa 1976). 2012 May 1;37(10):860-74. doi: 10.1097/BRS.0b013e3182376508.
PubMed 22127268Yoon J, Scott JY, Phibbs CS, Wagner TH. Recent trends in Veterans Affairs chronic condition spending. Popul Health Manag. 2011 Dec;14(6):293-8. doi: 10.1089/pop.2010.0079. Epub 2011 Nov 1.
PubMed 22044350McKellar J, Wagner T, Harris A, Oehlert M, Buckley S, Moos R. One-year outcomes of telephone case monitoring for patients with substance use disorder. Addict Behav. 2012 Oct;37(10):1069-74. doi: 10.1016/j.addbeh.2012.03.009. Epub 2012 Mar 13.
PubMed 22651986Bakaeen FG, Sethi G, Wagner TH, Kelly R, Lee K, Upadhyay A, Thai H, Juneman E, Goldman S, Holman WL. Coronary artery bypass graft patency: residents versus attending surgeons. Ann Thorac Surg. 2012 Aug;94(2):482-8; discussion 488. doi: 10.1016/j.athoracsur.2012.04.039. Epub 2012 Jun 13.
PubMed 22698772Goldman S, Sethi GK, Holman W, Thai H, McFalls E, Ward HB, Kelly RF, Rhenman B, Tobler GH, Bakaeen FG, Huh J, Soltero E, Moursi M, Haime M, Crittenden M, Kasirajan V, Ratliff M, Pett S, Irimpen A, Gunnar W, Thomas D, Fremes S, Moritz T, Reda D, Harrison L, Wagner TH, Wang Y, Planting L, Miller M, Rodriguez Y, Juneman E, Morrison D, Pierce MK, Kreamer S, Shih MC, Lee K. Radial artery grafts vs saphenous vein grafts in coronary artery bypass surgery: a randomized trial. JAMA. 2011 Jan 12;305(2):167-74. doi: 10.1001/jama.2010.1976.
PubMed 21224458Wagner TH, Holman W, Lee K, Sethi G, Ananth L, Thai H, Goldman S. The generalizability of participants in Veterans Affairs Cooperative Studies Program 474, a multi-site randomized cardiac bypass surgery trial. Contemp Clin Trials. 2011 Mar;32(2):260-6. doi: 10.1016/j.cct.2010.11.008. Epub 2010 Nov 13.
PubMed 21078416Humphreys K, Wagner TH, Gage M. If substance use disorder treatment more than offsets its costs, why don't more medical centers want to provide it? A budget impact analysis in the Veterans Health Administration. J Subst Abuse Treat. 2011 Oct;41(3):243-51. doi: 10.1016/j.jsat.2011.04.006. Epub 2011 Jun 12.
PubMed 21664790Wagner TH, Sethi G, Holman W, Lee K, Bakaeen FG, Upadhyay A, McFalls E, Tobler HG, Kelly RF, Crittenden MD, Thai H, Goldman S. Costs and quality of life associated with radial artery and saphenous vein cardiac bypass surgery: results from a Veterans Affairs multisite trial. Am J Surg. 2011 Nov;202(5):532-5. doi: 10.1016/j.amjsurg.2011.06.011. Epub 2011 Aug 26.
PubMed 21872209Goldman S, McCarren M, Sethi GK, Holman W, Bakaeen FG, Wagner TH, Wang Y, Shih MC, Edson R; CSP #474 Investigators. Long-Term Mortality Follow-Up of Radial Artery Versus Saphenous Vein in Coronary Artery Bypass Grafting: A Multicenter, Randomized Trial. Circulation. 2022 Oct 25;146(17):1323-1325. doi: 10.1161/CIRCULATIONAHA.122.062343. Epub 2022 Oct 24. No abstract available.
PubMed 36279414
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CSP #474 - Radial Artery vs. Saphenous Vein Grafts in Coronary Artery Bypass Surgery (Radial Artery)
- ClinicalTrials.gov ID
- NCT00054847
- Acronym / sponsor ID
- 474
- Conditions
- Cardiovascular Disease, Coronary Artery Disease
- Keywords
- CABG, cardiovascular, chronic diseases, clinical trial, heart, multi-site trial, prospective
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 733 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Feb 2003
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 13 Feb 2003 (estimated)
- Results
- Posted 14 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
VA patients with coronary artery disease and who have agreed to undergo coronary artery bypass graft surgery would be randomized to receive either radial artery or saphenous vein to the study vessel. The primary outcome variable is graft patency at one year.
Detailed description
Primary Hypothesis:
Radial artery grafts will have a higher graft patency rate at one year after coronary artery bypass graft surgery (CABG) compared to saphenous vein grafts.
Secondary Hypotheses:
Determine if there are any differences in clinical outcomes, cost and quality of life in patients receiving radial artery versus saphenous vein grafts.
Intervention: 1) Saphenous vein graft. This is the standard conduit for coronary artery bypass grafting to all areas of the heart except the left anterior descending (LAD) artery. 2) Radial artery. This is the experimental conduit. Preference should be given to harvesting from the non-dominant arm.
Primary Outcomes: 1-year post CABG surgery patency rates
Study Abstract:
Although the radial artery was introduced as a potential conduit for coronary artery bypass grafting in the 1970s, enthusiasm for its use was limited by the technical difficulty of harvesting the vessel and problems with perioperative vascular spasm. In spite of this, some surgeons persisted based on their belief that arterial conduits would be better than vein grafts, in terms of long-term patency. With the development of new harvesting techniques and the introduction of calcium channel blockers to prevent vasospasm, the use of the radial artery graft has increased in recent years. This use of the radial artery as a conduit is not based on any long-term prospective data regarding its patency. However, because the VA has been a leader in defining the long-term efficacy/patency of saphenous vein and internal mammary grafts, it is appropriate for the VA to investigate radial artery grafts. In fact, the VA under its Cooperative Studies Program, is probably the only health care delivery system that has the ability to undertake this study.
Study Design:
The study is a prospective, randomized, unblinded clinical trial. The population consists of VA patients with coronary artery disease documented by coronary arteriography and who have agreed to undergo coronary artery bypass surgery. Medical conditions which could affect blood flow through the patient's arm are the main exclusion criteria. These include Raynaud's symptoms, positive Allen test, neurologic or musculoskeletal disease affecting the arm and patients with one arm.
Patients who are eligible and agree to participate in the study will be randomly assigned to receive one radial artery graft or one saphenous vein graft to the following vessels: left anterior descending if internal mammary not used, circumflex, diagonal, and right coronary artery. The surgeon will determine the subject vessel preoperatively by selecting the vessel that is suitable for grafting.
The stratification factors will be the participating hospital and which vessel is to be bypassed, left anterior descending versus all other vessels.
History, physical examination, laboratory tests, and cardiac catheterization will be performed at baseline and at one year. Follow-up clinic visits will be at two weeks, three, six, and nine months post CABG. Coronary angiography will be performed one week and one year post surgery. Quality of life and hand/leg functional status will be assessed at baseline, three months, and one year. Cost measures will be captured.
Biostatistical Considerations:
For this trial, a sample size of 874 randomized patients will be required. This will provide 90% power to detect a difference in one-year patency rates of 92% for the radial artery versus 83% for the saphenous vein and an expected one-year catheter completion rate of 65%.
This is a five year study. There will be four years of patient accrual and one year of follow-up. Nine participating VA medical centers will be expected to randomize two patients per month.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saphenous Vein Graft | Active comparator | Procedure: saphenous vein graftSaphenous Vein Graft |
| Radial Artery Graft | Active comparator | Procedure: radial artery graftRadial Artery Graft |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients needing coronary artery bypass grafts.
Key exclusion criteria (17 listed)
- Patients who require only a single vessel bypass and in whom the internal mammary artery will be used for that graft
- Patients with previous stripping and ligation of saphenous veins and in whom no venous conduit is available for bypass
- Patients with Raynaud's symptoms
- Patients who have a creatinine above 2.0 mg/dL or require hemodialysis
- Patients with a positive Allen test
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 |
|---|---|---|
| saphenous vein graftSaphenous vein harvested from the arm is used as a conduit for CABG. | Procedure or surgery | Saphenous Vein Graft |
| radial artery graftRadial artery harvested from the arm is used as a conduit for CABG. | Procedure or surgery | Radial Artery Graft |
Primary outcome
To Compare 1-year Angiographic Patency of Radial Artery Grafts Versus Saphenous Vein Grafts in Patients Undergoing Elective Coronary Artery Bypass Graft (CABG) Surgery.
Time frame: 1 year
The primary end point was angiographic graft patency at 1 year after coronary artery bypass surgery, defined as any opacification of distal target by injection of the graft. The window for the 1-year angiogram was 2 to 24 months. This window was chosen to capture early clinically indicated angiograms and late selective angiograms in patients who did not have symptoms. Study grafts that were occluded at 1 week after coronary artery bypass graft surgery were considered occluded at 1 year. One-year graft patency data were missing if patients whose study grafts were patent at 1 week did not undergo an angiogram within the time window or if the central angiography laboratory was not able to determine graft patency.
3 secondary outcomes
Death
Time frame: Within 1 year of surgery.
Myocardial Infarction
Time frame: Within 1 year of bypass surgery
Stroke
Time frame: Within 1 year of bypass surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22138312Mudumbai SC, Wagner T, Mahajan S, King R, Heidenreich PA, Hlatky M, Wallace A, Mariano ER. Vascular surgery patients prescribed preoperative beta-blockers experienced a decrease in the maximal heart rate observed during induction of general anesthesia. J Cardiothorac Vasc Anesth. 2012 Jun;26(3):414-9. doi: 10.1053/j.jvca.2011.09.027. Epub 2011 Dec 3.
- Results publication: PubMed 22127268Sinnott PL, Siroka AM, Shane AC, Trafton JA, Wagner TH. Identifying neck and back pain in administrative data: defining the right cohort. Spine (Phila Pa 1976). 2012 May 1;37(10):860-74. doi: 10.1097/BRS.0b013e3182376508.
- Results publication: PubMed 22044350Yoon J, Scott JY, Phibbs CS, Wagner TH. Recent trends in Veterans Affairs chronic condition spending. Popul Health Manag. 2011 Dec;14(6):293-8. doi: 10.1089/pop.2010.0079. Epub 2011 Nov 1.
- Results publication: PubMed 22651986McKellar J, Wagner T, Harris A, Oehlert M, Buckley S, Moos R. One-year outcomes of telephone case monitoring for patients with substance use disorder. Addict Behav. 2012 Oct;37(10):1069-74. doi: 10.1016/j.addbeh.2012.03.009. Epub 2012 Mar 13.
- Results publication: PubMed 22698772Bakaeen FG, Sethi G, Wagner TH, Kelly R, Lee K, Upadhyay A, Thai H, Juneman E, Goldman S, Holman WL. Coronary artery bypass graft patency: residents versus attending surgeons. Ann Thorac Surg. 2012 Aug;94(2):482-8; discussion 488. doi: 10.1016/j.athoracsur.2012.04.039. Epub 2012 Jun 13.
- Results publication: PubMed 21224458Goldman S, Sethi GK, Holman W, Thai H, McFalls E, Ward HB, Kelly RF, Rhenman B, Tobler GH, Bakaeen FG, Huh J, Soltero E, Moursi M, Haime M, Crittenden M, Kasirajan V, Ratliff M, Pett S, Irimpen A, Gunnar W, Thomas D, Fremes S, Moritz T, Reda D, Harrison L, Wagner TH, Wang Y, Planting L, Miller M, Rodriguez Y, Juneman E, Morrison D, Pierce MK, Kreamer S, Shih MC, Lee K. Radial artery grafts vs saphenous vein grafts in coronary artery bypass surgery: a randomized trial. JAMA. 2011 Jan 12;305(2):167-74. doi: 10.1001/jama.2010.1976.
- Results publication: PubMed 21078416Wagner TH, Holman W, Lee K, Sethi G, Ananth L, Thai H, Goldman S. The generalizability of participants in Veterans Affairs Cooperative Studies Program 474, a multi-site randomized cardiac bypass surgery trial. Contemp Clin Trials. 2011 Mar;32(2):260-6. doi: 10.1016/j.cct.2010.11.008. Epub 2010 Nov 13.
- Results publication: PubMed 21664790Humphreys K, Wagner TH, Gage M. If substance use disorder treatment more than offsets its costs, why don't more medical centers want to provide it? A budget impact analysis in the Veterans Health Administration. J Subst Abuse Treat. 2011 Oct;41(3):243-51. doi: 10.1016/j.jsat.2011.04.006. Epub 2011 Jun 12.
- Results publication: PubMed 21872209Wagner TH, Sethi G, Holman W, Lee K, Bakaeen FG, Upadhyay A, McFalls E, Tobler HG, Kelly RF, Crittenden MD, Thai H, Goldman S. Costs and quality of life associated with radial artery and saphenous vein cardiac bypass surgery: results from a Veterans Affairs multisite trial. Am J Surg. 2011 Nov;202(5):532-5. doi: 10.1016/j.amjsurg.2011.06.011. Epub 2011 Aug 26.
- Derived from this study: PubMed 36279414Goldman S, McCarren M, Sethi GK, Holman W, Bakaeen FG, Wagner TH, Wang Y, Shih MC, Edson R; CSP #474 Investigators. Long-Term Mortality Follow-Up of Radial Artery Versus Saphenous Vein in Coronary Artery Bypass Grafting: A Multicenter, Randomized Trial. Circulation. 2022 Oct 25;146(17):1323-1325. doi: 10.1161/CIRCULATIONAHA.122.062343. Epub 2022 Oct 24. No abstract available.
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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.
Steven Goldman, MD study chair
Southern Arizona VA Health Care System
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing saphenous vein graft and radial artery graft in people with Cardiovascular Disease and Coronary Artery Disease, run by US Department of Veterans Affairs at 11 sites in United States.
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 1 inclusion and 17 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 5 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. 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?
Yes. Results are posted in the registry (first posted 14 Mar 2014). 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?
To Compare 1-year Angiographic Patency of Radial Artery Grafts Versus Saphenous Vein Grafts in Patients Undergoing Elective Coronary Artery Bypass Graft (CABG) Surgery. (time frame: 1 year). 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 NCT00054847, which also lists 10 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 5 May 2014.