Coronary Bypass Graft StenosisOCTOCABNCT05129228
Optical Coherence Tomography of the Saphenous Vein Graft
A study testing OCT-guided saphenous vein CABG in people with Coronary Bypass Graft Stenosis, run by St. Francis Hospital, New York at 1 site in United States.
Trial summary
OCTOCAB is a prospective, randomized (1:1), single-center trial. The purpose of this study is to determine whether intravascular optical coherence tomography (OCT) guided saphenous vein grafting in coronary artery bypass surgery will reduce the rate of early vein graft failure (VGF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Bypass Graft Stenosis
- What is being tested?
- OCT-guided saphenous vein CABG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 760 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2022to 4 Apr 2026
- 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
- Subject must be at least 18 years of age.
- Subject must have evidence of myocardial ischemia (e.g., stable angina, silent ischemia (ischemia in the absence of chest pain or other anginal equivalents), unstable angina, or acute myocardial infarction) suitable for elective CABG.
- Subject must have undergone coronary angiography identifying at least one lesion that is clinically appropriate and suitable for saphenous vein bypass grafting.
- Subject must provide written Informed Consent prior to any study related procedure.
Who cannot join
- STEMI ≤24 hours from the onset of ischemic symptoms
- Creatinine clearance ≤30 ml/min/1.73 m2 (as calculated by MDRD formula for estimated GFR) and not on dialysis.
- Hypotension, shock or need for mechanical support or intravenous vasopressors at the time that the patient would be undergoing the index procedure.
- CHF (Killip class >2 or NYHA class >3)
- LVEF <30% by the most recent imaging test within 6 months prior to procedure. If no LVEF test result within 6 months is available, it must be assessed by echocardiography, multiple gated acquisition (MUGA), magnetic resonance imaging (MRI), ventriculography (LV gram) or other method.
- Unstable ventricular arrhythmias
Show all 22Show fewer
- Concomitant multi-valve surgery or major aortic root surgery.
- Planned non-cardiac surgery within 24 months after the index procedure
- Prior CABG
- Any planned PCI within any target vessel(s) within 24 months.
- Subject has known hypersensitivity or contraindication to any of the study drugs (including aspirin, all P2Y12 inhibitors).
- Subject has received a heart transplant.
- Subject is receiving immunosuppressant therapy or has known immunosuppressive or severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.).
- Subject has previously received or is scheduled to receive radiotherapy to a coronary artery (vascular brachytherapy), or the chest/mediastinum.
- Subject has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3.
- Subject has a documented or suspected hepatic disorder as defined as cirrhosis or Child-Pugh ≥ Class B.
- Subject has a history of bleeding diathesis or coagulopathy.
- Subject has life expectancy <2 years for any non-cardiac cause.
- Pregnant or nursing subjects and those who plan pregnancy in the period up to 2 years following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.
- Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
- Conduit exclusion criteria
- 1. Severe conduit tortuosity of venous conduit (e.g., with varicosities) such that it is unlikely that the OCT catheter can be delivered without vascular damage.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
St Francis Hospital
Roslyn, New York, 11576
Elizabeth S. Haag, RN, 516-622-4512, Elizabeth.Haag@chsli.org
Ziad A. Ali, MD, DPhil, 516-622-4552, ziadali.mail@gmail.com
About this study
Official title: Intraoperative Optical Coherence Tomography of the Saphenous Vein Conduit in Patients Undergoing Coronary Artery Bypass Surgery
OCTOCAB is a prospective, randomized (1:1), single-center trial. The purpose of this study is to determine whether intravascular optical coherence tomography (OCT) guided saphenous vein grafting in coronary artery bypass surgery will reduce the rate of early vein graft failure (VGF).
Read the detailed description
Within the first year of coronary artery bypass grafting (CABG) surgery, the saphenous vein grafts have a failure rate of 10 to 25%. Visual inspection of the vein graft conduit is the current standard in determining the quality of the vein segment. However, there may be intraluminal abnormalities that are undetectable via a visual inspection. OCT examination, using the ILUMIEN OPTIS NEXT OCT Imaging system, of endoscopically harvested saphenous vein conduits will indicate such pathology and enable the surgeon to assess the quality of the harvested vein at the intravascular level.
This study is designed to demonstrate the superiority of OCT-guided saphenous vein CABG in improving the rates of early VGF and the overall outcome of CABG.
The study will follow two randomization arms: OCT-guided saphenous vein CABG (interventional arm) vs. visual inspection-guided saphenous vein CABG (standard of care arm). The analysis of subjects will be with respect to their analyzed group.
Following enrollment, participants will be followed for up to 10 years. The primary endpoint is per graft incidence of vein graft failure. The assessment of the vein graft will be conducted via coronary CT angiogram (CCTA) at 12 months. In the case where the participant has unplanned angiogram due to clinical reasons, prior to the 12 months, the condition of the graft will be determined via the angiogram. Unless all target grafts have reached the endpoint prior to the 12 month time point, a CCTA will be required.
To achieve the power level of 85% at the significance level of 0.025, 760 patients is the anticipated sample size. Analysis will be conducted at the graft level with a Linear Mixed model to account for any potential patient effects.
- Conditions
- Coronary Bypass Graft Stenosis
- Being tested
- OCT-guided saphenous vein CABG
- Keywords
- Coronary Artery Bypass Surgery, Saphenous Vein Graft, Intravascular Optical Coherence Tomography, Vein Graft Failure, Coronary Computed Tomography Angiography, Coronary Artery Disease
- 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.
OCT-guided saphenous vein CABGDevice
Also called ILUMIEN OPTIS NEXT OCT Imaging System, ILUMIEN OPTIS OCT Imaging System, OPTIS Integrated OCT Imaging System, OPTIS Mobile OCT Imaging System
OCT examination of harvested saphenous vein conduits will indicate pathology. Under the surgeon's discretion the conduit segments with pathology will not be grafted.
| Study group | Role | What they receive |
|---|---|---|
| OCT-guided saphenous vein graft coronary artery bypass graft surgery | Experimental | Optical Coherence Tomography (OCT) provides high quality intravascular images by using infrared light. OCT will assess the harvested saphenous vein conduit in Coronary Bypass Graft Surgery (CABG). Abnormalities found in the harvested conduits via OCT, at the discretion of the surgeon, will not be utilized for CABG. Receives: Device: OCT-guided saphenous vein CABG |
| Visual inspection-guided saphenous vein graft coronary artery graft surgery | No intervention | Harvested saphenous vein conduits will be assessed visually and will undergo a blinded OCT. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vein graft failure (VGF)
Per graft incidence of VGF defined as greater than or equal to 70% in the body of the graft on coronary CT angiography (CCTA)
Measured: 12 months
Secondary outcomes (16)
Target graft failure (TGF)
Composite time-to-first event rate of cardiac death, target graft myocardial infarction (TG-MI), or ischemia-driven target graft revascularization (ID-TGR)
Measured: 12 months
Per graft incidence of ischemic vein graft failure
Greater than or equal to 70% stenosis
Measured: 12 months
Per graft incidence anatomic vein graft failure
Greater than or equal to 50% stenosis
Measured: 12 months
Per patient incidence of vein graft patency
Vein graft having less than 50% stenosis
Measured: 12 months
Per patient incidence of ischemic vein graft failure
Greater than or equal to 70% stenosis
Measured: 12 months
Per patient incidence of anatomic vein graft failure
Greater than or equal to 50% stenosis
Measured: 12 months
Mean vein graft diameter stenosis
Measured: 12 months
Mean vein graft area stenosis
Measured: 12 months
All-cause mortality
Measured: 12 months
Cardiac and non-cardiac mortality
Measured: 12 months
All Myocardial Infarction (MI)
Measured: 12 months
Target graft myocardial infarction (TG-MI) and Non-Target graft myocardial infarction (non-TG-MI)
Measured: 12 months
All revascularization
Measured: 12 months
Ischemia driven (ID)-revascularization and Non-ischemia driven (ID)-revascularization
Measured: 12 months
Ischemia driven-target graft failure (ID-TGR)
Measured: 12 months
Ischemia driven (ID)-revascularization of target native coronary artery subtended by the graft
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start4 Apr 2022
- Primary completion4 Apr 2024 (estimated)
- Study completion4 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Coronary Bypass Graft StenosisStudies 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
- Model description
- OCT-guided saphenous vein CABG
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 760 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Francis Hospital, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ziad Ali, MD, DPhil, St. Francis Hospital, New York
- Investigators
- Ziad A. Ali, MD,DPhil, Principal investigator, WVU Medicine Thomas HospitalsEdward F. Lundy, MD, PhD, Principal investigator, WVU Medicine Thomas Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05129228
- Sponsor's protocol ID
- 21-10
- Acronym
- OCTOCAB
- Status last verified
- May 2022
- First submitted
- 15 Nov 2021
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Antonopoulos AS, Odutayo A, Oikonomou EK, Trivella M, Petrou M, Collins GS, Antoniades C; SAFINOUS-CABG (Saphenous Vein Graft Failure-An Outcomes Study in Coronary Artery Bypass Grafting) group. Development of a risk score for early saphenous vein graft failure: An individual patient data meta-analysis. J Thorac Cardiovasc Surg. 2020 Jul;160(1):116-127.e4. doi: 10.1016/j.jtcvs.2019.07.086. Epub 2019 Aug 26.
PubMed 31606176Gaudino M, Di Franco A, Bhatt DL, Alexander JH, Abbate A, Azzalini L, Sandner S, Sharma G, Rao SV, Crea F, Fremes SE, Bangalore S. The association between coronary graft patency and clinical status in patients with coronary artery disease. Eur Heart J. 2021 Apr 7;42(14):1433-1441. doi: 10.1093/eurheartj/ehab096.
PubMed 33709098Caliskan E, de Souza DR, Boning A, Liakopoulos OJ, Choi YH, Pepper J, Gibson CM, Perrault LP, Wolf RK, Kim KB, Emmert MY. Saphenous vein grafts in contemporary coronary artery bypass graft surgery. Nat Rev Cardiol. 2020 Mar;17(3):155-169. doi: 10.1038/s41569-019-0249-3. Epub 2019 Aug 27.
PubMed 31455868Tan ES, van der Meer J, Jan de Kam P, Dunselman PH, Mulder BJ, Ascoop CA, Pfisterer M, Lie KI. Worse clinical outcome but similar graft patency in women versus men one year after coronary artery bypass graft surgery owing to an excess of exposed risk factors in women. CABADAS. Research Group of the Interuniversity Cardiology Institute of The Netherlands. Coronary Artery Bypass graft occlusion by Aspirin, Dipyridamole and Acenocoumarol/phenoprocoumon Study. J Am Coll Cardiol. 1999 Nov 15;34(6):1760-8. doi: 10.1016/s0735-1097(99)00404-0.
PubMed 10577567Fitzgibbon GM, Kafka HP, Leach AJ, Keon WJ, Hooper GD, Burton JR. Coronary bypass graft fate and patient outcome: angiographic follow-up of 5,065 grafts related to survival and reoperation in 1,388 patients during 25 years. J Am Coll Cardiol. 1996 Sep;28(3):616-26. doi: 10.1016/0735-1097(96)00206-9.
PubMed 8772748Goldman S, Copeland J, Moritz T, Henderson W, Zadina K, Ovitt T, Doherty J, Read R, Chesler E, Sako Y, et al. Saphenous vein graft patency 1 year after coronary artery bypass surgery and effects of antiplatelet therapy. Results of a Veterans Administration Cooperative Study. Circulation. 1989 Nov;80(5):1190-7. doi: 10.1161/01.cir.80.5.1190.
PubMed 2680158Mehta RH, Ferguson TB, Lopes RD, Hafley GE, Mack MJ, Kouchoukos NT, Gibson CM, Harrington RA, Califf RM, Peterson ED, Alexander JH; Project of Ex-vivo Vein Graft Engineering via Transfection (PREVENT) IV Investigators. Saphenous vein grafts with multiple versus single distal targets in patients undergoing coronary artery bypass surgery: one-year graft failure and five-year outcomes from the Project of Ex-Vivo Vein Graft Engineering via Transfection (PREVENT) IV trial. Circulation. 2011 Jul 19;124(3):280-8. doi: 10.1161/CIRCULATIONAHA.110.991299. Epub 2011 Jun 27.
PubMed 21709060Hattler B, Messenger JC, Shroyer AL, Collins JF, Haugen SJ, Garcia JA, Baltz JH, Cleveland JC Jr, Novitzky D, Grover FL; Veterans Affairs Randomized On/Off Bypass (ROOBY) Study Group. Off-Pump coronary artery bypass surgery is associated with worse arterial and saphenous vein graft patency and less effective revascularization: Results from the Veterans Affairs Randomized On/Off Bypass (ROOBY) trial. Circulation. 2012 Jun 12;125(23):2827-35. doi: 10.1161/CIRCULATIONAHA.111.069260. Epub 2012 May 16.
PubMed 22592900Raza S, Blackstone EH, Houghtaling PL, Rajeswaran J, Riaz H, Bakaeen FG, Lincoff AM, Sabik JF 3rd. Influence of Diabetes on Long-Term Coronary Artery Bypass Graft Patency. J Am Coll Cardiol. 2017 Aug 1;70(5):515-524. doi: 10.1016/j.jacc.2017.05.061.
PubMed 28750693Sabik JF 3rd, Lytle BW, Blackstone EH, Houghtaling PL, Cosgrove DM. Comparison of saphenous vein and internal thoracic artery graft patency by coronary system. Ann Thorac Surg. 2005 Feb;79(2):544-51; discussion 544-51. doi: 10.1016/j.athoracsur.2004.07.047.
PubMed 15680832
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Optical Coherence Tomography of the Saphenous Vein Conduit in Patients Undergoing Coronary Artery Bypass Surgery
- ClinicalTrials.gov ID
- NCT05129228
- Acronym / sponsor ID
- OCTOCAB / 21-10
- Conditions
- Coronary Bypass Graft Stenosis
- Keywords
- Coronary Artery Bypass Surgery, Saphenous Vein Graft, Intravascular Optical Coherence Tomography, Vein Graft Failure, Coronary Computed Tomography Angiography, Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 760 participants (estimated)
- Lead sponsor
- St. Francis Hospital, New YorkUniversity, hospital or other
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 4 Apr 2024 (estimated)
- Study completion
- 4 Apr 2026 (estimated)
- First posted
- 22 Nov 2021 (actual)
- 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.
OCTOCAB is a prospective, randomized (1:1), single-center trial. The purpose of this study is to determine whether intravascular optical coherence tomography (OCT) guided saphenous vein grafting in coronary artery bypass surgery will reduce the rate of early vein graft failure (VGF).
Detailed description
Within the first year of coronary artery bypass grafting (CABG) surgery, the saphenous vein grafts have a failure rate of 10 to 25%. Visual inspection of the vein graft conduit is the current standard in determining the quality of the vein segment. However, there may be intraluminal abnormalities that are undetectable via a visual inspection. OCT examination, using the ILUMIEN OPTIS NEXT OCT Imaging system, of endoscopically harvested saphenous vein conduits will indicate such pathology and enable the surgeon to assess the quality of the harvested vein at the intravascular level.
This study is designed to demonstrate the superiority of OCT-guided saphenous vein CABG in improving the rates of early VGF and the overall outcome of CABG.
The study will follow two randomization arms: OCT-guided saphenous vein CABG (interventional arm) vs. visual inspection-guided saphenous vein CABG (standard of care arm). The analysis of subjects will be with respect to their analyzed group.
Following enrollment, participants will be followed for up to 10 years. The primary endpoint is per graft incidence of vein graft failure. The assessment of the vein graft will be conducted via coronary CT angiogram (CCTA) at 12 months. In the case where the participant has unplanned angiogram due to clinical reasons, prior to the 12 months, the condition of the graft will be determined via the angiogram. Unless all target grafts have reached the endpoint prior to the 12 month time point, a CCTA will be required.
To achieve the power level of 85% at the significance level of 0.025, 760 patients is the anticipated sample size. Analysis will be conducted at the graft level with a Linear Mixed model to account for any potential patient effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- OCT-guided saphenous vein CABG
| Arm | Type | Receives |
|---|---|---|
| OCT-guided saphenous vein graft coronary artery bypass graft surgery | Experimental | Device: OCT-guided saphenous vein CABGOptical Coherence Tomography (OCT) provides high quality intravascular images by using infrared light. OCT will assess the harvested saphenous vein conduit in Coronary Bypass Graft Surgery (CABG). Abnormalities found in the harvested conduits via OCT, at the discretion of the surgeon, will not be utilized for CABG. |
| Visual inspection-guided saphenous vein graft coronary artery graft surgery | No intervention | –Harvested saphenous vein conduits will be assessed visually and will undergo a blinded OCT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject must be at least 18 years of age.
- Subject must have evidence of myocardial ischemia (e.g., stable angina, silent ischemia (ischemia in the absence of chest pain or other anginal equivalents), unstable angina, or acute myocardial infarction) suitable for elective CABG.
- Subject must have undergone coronary angiography identifying at least one lesion that is clinically appropriate and suitable for saphenous vein bypass grafting.
- Subject must provide written Informed Consent prior to any study related procedure.
Key exclusion criteria (22 listed)
- STEMI ≤24 hours from the onset of ischemic symptoms
- Creatinine clearance ≤30 ml/min/1.73 m2 (as calculated by MDRD formula for estimated GFR) and not on dialysis.
- Hypotension, shock or need for mechanical support or intravenous vasopressors at the time that the patient would be undergoing the index procedure.
- CHF (Killip class >2 or NYHA class >3)
- LVEF <30% by the most recent imaging test within 6 months prior to procedure. If no LVEF test result within 6 months is available, it must be assessed by echocardiography, multiple gated acquisition (MUGA), magnetic resonance imaging (MRI), ventriculography (LV gram) or other method.
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 |
|---|---|---|
| OCT-guided saphenous vein CABGAlso: ILUMIEN OPTIS NEXT OCT Imaging System, ILUMIEN OPTIS OCT Imaging System, OPTIS Integrated OCT Imaging System, OPTIS Mobile OCT Imaging SystemOCT examination of harvested saphenous vein conduits will indicate pathology. Under the surgeon's discretion the conduit segments with pathology will not be grafted. | Device | OCT-guided saphenous vein graft coronary artery bypass graft surgery |
Primary outcome
Vein graft failure (VGF)
Time frame: 12 months
Per graft incidence of VGF defined as greater than or equal to 70% in the body of the graft on coronary CT angiography (CCTA)
16 secondary outcomes
Target graft failure (TGF)
Time frame: 12 months
Per graft incidence of ischemic vein graft failure
Time frame: 12 months
Per graft incidence anatomic vein graft failure
Time frame: 12 months
Per patient incidence of vein graft patency
Time frame: 12 months
Per patient incidence of ischemic vein graft failure
Time frame: 12 months
Per patient incidence of anatomic vein graft failure
Time frame: 12 months
Mean vein graft diameter stenosis
Time frame: 12 months
Mean vein graft area stenosis
Time frame: 12 months
All-cause mortality
Time frame: 12 months
Cardiac and non-cardiac mortality
Time frame: 12 months
All Myocardial Infarction (MI)
Time frame: 12 months
Target graft myocardial infarction (TG-MI) and Non-Target graft myocardial infarction (non-TG-MI)
Time frame: 12 months
All revascularization
Time frame: 12 months
Ischemia driven (ID)-revascularization and Non-ischemia driven (ID)-revascularization
Time frame: 12 months
Ischemia driven-target graft failure (ID-TGR)
Time frame: 12 months
Ischemia driven (ID)-revascularization of target native coronary artery subtended by the graft
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- Background: PubMed 31606176Antonopoulos AS, Odutayo A, Oikonomou EK, Trivella M, Petrou M, Collins GS, Antoniades C; SAFINOUS-CABG (Saphenous Vein Graft Failure-An Outcomes Study in Coronary Artery Bypass Grafting) group. Development of a risk score for early saphenous vein graft failure: An individual patient data meta-analysis. J Thorac Cardiovasc Surg. 2020 Jul;160(1):116-127.e4. doi: 10.1016/j.jtcvs.2019.07.086. Epub 2019 Aug 26.
- Background: PubMed 33709098Gaudino M, Di Franco A, Bhatt DL, Alexander JH, Abbate A, Azzalini L, Sandner S, Sharma G, Rao SV, Crea F, Fremes SE, Bangalore S. The association between coronary graft patency and clinical status in patients with coronary artery disease. Eur Heart J. 2021 Apr 7;42(14):1433-1441. doi: 10.1093/eurheartj/ehab096.
- Background: PubMed 31455868Caliskan E, de Souza DR, Boning A, Liakopoulos OJ, Choi YH, Pepper J, Gibson CM, Perrault LP, Wolf RK, Kim KB, Emmert MY. Saphenous vein grafts in contemporary coronary artery bypass graft surgery. Nat Rev Cardiol. 2020 Mar;17(3):155-169. doi: 10.1038/s41569-019-0249-3. Epub 2019 Aug 27.
- Background: PubMed 10577567Tan ES, van der Meer J, Jan de Kam P, Dunselman PH, Mulder BJ, Ascoop CA, Pfisterer M, Lie KI. Worse clinical outcome but similar graft patency in women versus men one year after coronary artery bypass graft surgery owing to an excess of exposed risk factors in women. CABADAS. Research Group of the Interuniversity Cardiology Institute of The Netherlands. Coronary Artery Bypass graft occlusion by Aspirin, Dipyridamole and Acenocoumarol/phenoprocoumon Study. J Am Coll Cardiol. 1999 Nov 15;34(6):1760-8. doi: 10.1016/s0735-1097(99)00404-0.
- Background: PubMed 8772748Fitzgibbon GM, Kafka HP, Leach AJ, Keon WJ, Hooper GD, Burton JR. Coronary bypass graft fate and patient outcome: angiographic follow-up of 5,065 grafts related to survival and reoperation in 1,388 patients during 25 years. J Am Coll Cardiol. 1996 Sep;28(3):616-26. doi: 10.1016/0735-1097(96)00206-9.
- Background: PubMed 2680158Goldman S, Copeland J, Moritz T, Henderson W, Zadina K, Ovitt T, Doherty J, Read R, Chesler E, Sako Y, et al. Saphenous vein graft patency 1 year after coronary artery bypass surgery and effects of antiplatelet therapy. Results of a Veterans Administration Cooperative Study. Circulation. 1989 Nov;80(5):1190-7. doi: 10.1161/01.cir.80.5.1190.
- Background: PubMed 21709060Mehta RH, Ferguson TB, Lopes RD, Hafley GE, Mack MJ, Kouchoukos NT, Gibson CM, Harrington RA, Califf RM, Peterson ED, Alexander JH; Project of Ex-vivo Vein Graft Engineering via Transfection (PREVENT) IV Investigators. Saphenous vein grafts with multiple versus single distal targets in patients undergoing coronary artery bypass surgery: one-year graft failure and five-year outcomes from the Project of Ex-Vivo Vein Graft Engineering via Transfection (PREVENT) IV trial. Circulation. 2011 Jul 19;124(3):280-8. doi: 10.1161/CIRCULATIONAHA.110.991299. Epub 2011 Jun 27.
- Background: PubMed 22592900Hattler B, Messenger JC, Shroyer AL, Collins JF, Haugen SJ, Garcia JA, Baltz JH, Cleveland JC Jr, Novitzky D, Grover FL; Veterans Affairs Randomized On/Off Bypass (ROOBY) Study Group. Off-Pump coronary artery bypass surgery is associated with worse arterial and saphenous vein graft patency and less effective revascularization: Results from the Veterans Affairs Randomized On/Off Bypass (ROOBY) trial. Circulation. 2012 Jun 12;125(23):2827-35. doi: 10.1161/CIRCULATIONAHA.111.069260. Epub 2012 May 16.
- Background: PubMed 28750693Raza S, Blackstone EH, Houghtaling PL, Rajeswaran J, Riaz H, Bakaeen FG, Lincoff AM, Sabik JF 3rd. Influence of Diabetes on Long-Term Coronary Artery Bypass Graft Patency. J Am Coll Cardiol. 2017 Aug 1;70(5):515-524. doi: 10.1016/j.jacc.2017.05.061.
- Background: PubMed 15680832Sabik JF 3rd, Lytle BW, Blackstone EH, Houghtaling PL, Cosgrove DM. Comparison of saphenous vein and internal thoracic artery graft patency by coronary system. Ann Thorac Surg. 2005 Feb;79(2):544-51; discussion 544-51. doi: 10.1016/j.athoracsur.2004.07.047.
- Individual participant dataSharing planned: No
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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.
Ziad A. Ali, MD,DPhil principal investigator
WVU Medicine Thomas Hospitals
Edward F. Lundy, MD, PhD principal investigator
WVU Medicine Thomas Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OCT-guided saphenous vein CABG in people with Coronary Bypass Graft Stenosis, run by St. Francis Hospital, New York at 1 site 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 4 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 5 May 2022. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ziad A. Ali, MD,DPhil (516-622-4552, ziadali.mail@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vein graft failure (VGF) (time frame: 12 months). 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 NCT05129228, 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 2022.