OCT-Guided Coronary Bypass Grafting for Graft Failure (OCTOCAB Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: St. Francis Hospital, New York
No Placebo Group
Approved in 2 jurisdictions
Trial Summary
What is the purpose of this trial?This trial is testing whether using a special imaging technique during heart surgery can reduce early complications. It targets patients undergoing heart surgery, as their veins often have issues soon after the procedure. The imaging technique helps doctors find hidden problems.
Is OCT-guided coronary bypass grafting generally safe for humans?
The research does not provide specific safety data for OCT-guided coronary bypass grafting, but it does mention that optical coherence tomography (OCT) can help identify issues in saphenous vein grafts, which are commonly used in coronary bypass surgery. While the studies focus on identifying problems and treatment strategies, they do not directly address the safety of OCT-guided procedures.
34579What makes OCT-guided SV CABG unique compared to other treatments for graft failure?
OCT-guided SV CABG is unique because it uses optical coherence tomography (OCT) to provide detailed images of the inside of blood vessels, allowing doctors to precisely identify and treat problematic areas in saphenous vein grafts, which can improve the success of the surgery and reduce complications.
12349What data supports the effectiveness of the treatment OCT-guided saphenous vein CABG?
Optical coherence tomography (OCT) helps in identifying and analyzing atherosclerotic lesions (buildup of fats, cholesterol, and other substances in and on the artery walls) in saphenous vein grafts, which can guide successful stent placement and potentially improve outcomes in coronary bypass surgeries.
23689Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you have a known allergy or cannot take any of the study drugs like aspirin or P2Y12 inhibitors, you may not be eligible to participate.
Eligibility Criteria
This trial is for adults with myocardial ischemia suitable for elective coronary artery bypass grafting (CABG) who can consent to the study. Excluded are those with severe heart failure, recent STEMI, significant kidney dysfunction, unstable arrhythmias, prior CABG, extreme platelet counts, liver disease, short life expectancy due to non-cardiac causes or conditions that could affect participation or results.Inclusion Criteria
I have heart issues that may require bypass surgery.
I am 18 years old or older.
I have a heart blockage that can be treated with a vein graft.
Exclusion Criteria
I am undergoing or have undergone surgery on multiple heart valves or the main artery coming from my heart.
I have had coronary artery bypass surgery.
My heart failure is not severe (below Killip class 3 or NYHA class 4).
I am on long-term medication to suppress my immune system due to severe autoimmune disease.
I have had a heart transplant.
I do not have irregular heartbeats that are severe and uncontrolled.
I had a severe heart attack less than 24 hours ago.
My kidney function is low, but I am not on dialysis.
I do not need machines or IV drugs to maintain my blood pressure.
I am scheduled for a heart artery procedure within the next 2 years.
I have a history of bleeding disorders.
I am allergic or react badly to the drugs used in this study.
I have had or will have radiation therapy to my heart area or chest.
I have a liver condition.
Participant Groups
The OCTOCAB trial tests if using intravascular optical coherence tomography (OCT) during saphenous vein grafting in CABG surgery can lower early vein graft failure rates. It's a prospective study where participants are randomly assigned to receive either the standard procedure or the OCT-guided technique.
2Treatment groups
Experimental Treatment
Active Control
Group I: OCT-guided saphenous vein graft coronary artery bypass graft surgeryExperimental Treatment1 Intervention
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.
Group II: Visual inspection-guided saphenous vein graft coronary artery graft surgeryActive Control1 Intervention
Harvested saphenous vein conduits will be assessed visually and will undergo a blinded OCT.
OCT-guided saphenous vein CABG is already approved in European Union, United States for the following indications:
🇪🇺 Approved in European Union as OCT-Guided SV CABG for:
- Coronary artery bypass grafting
- Assessment of saphenous vein grafts
🇺🇸 Approved in United States as OCT-Guided SV CABG for:
- Coronary artery bypass grafting
- Evaluation of saphenous vein grafts
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
St Francis HospitalRoslyn, NY
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Who is running the clinical trial?
St. Francis Hospital, New YorkLead Sponsor
References
Value of saphenous vein graft markers during subsequent diagnostic cardiac catheterization. [2022]Although saphenous vein graft (SVG) markers have been available for many years, they have not been widely used in coronary artery bypass graft (CABG) surgery. This is likely due to the paucity of data regarding the utility of these markers in postsurgery cardiac catheterization.
Long-term patency of sequential and individual saphenous vein coronary bypass grafts. [2019]The long-term patency rates for individual and sequential saphenous vein grafts (SVG) as coronary bypass conduits are angiographically compared; the impact of native coronary vessel characteristics is investigated.
Evaluation of culprit saphenous vein graft lesions with optical coherence tomography in patients with acute coronary syndromes. [2022]This study sought to assess, with optical coherence tomography (OCT), presumably culprit atherosclerotic lesions of saphenous vein grafts (SVGs) in patients with acute coronary syndromes (ACS).
[Saphenous vein graft disease: causes, prevention, and contemporary treatment strategies]. [2018]Coronary bypass graft surgery provides symptomatic relief and a long life expectancy for most patients with coronary artery disease who have suitable vessels. Although arterial conduits are becoming more popular, saphenous vein grafts (SVG) are still frequently used in coronary artery bypass surgery since they are readily available, especially in emergency situations. However, SVG tend to degenerate over time, as nearly half of them develop significant stenosis and nearly 40% of them become completely occluded within a decade. Treatment options for SVG failure include redo-surgery, percutaneous intervention, and/or medical therapy. However, challenges in maintaining graft patency (as a predictor of long-term survival) and interventional complications (e.g., distal embolization, ''no-reflow,'' and higher rates of periprocedural myocardial infarction) are still ongoing problems for cardiologists and cardiovascular surgeons. This review discusses the possible causes of graft failure and the contemporary approaches for improving outcomes in patients undergoing coronary artery bypass graft surgery with at least one SVG.
Safety and clinical effectiveness of drug-eluting stents for saphenous vein graft intervention in older individuals: Results from the medicare-linked National Cardiovascular Data Registry(®) CathPCI Registry(®) (2005-2009). [2017]To evaluate the safety of drug-eluting stents (DES) when treating patients with failing saphenous vein grafts (SVG).
OCT imaging of aorto-coronary vein graft pathology modified by external stenting: 1-year post-surgery. [2017]The Venous External Support Trial (VEST) evaluated whether a novel external stent attenuated saphenous vein graft (SVG) disease assessed with intravascular ultrasound 1 year following coronary artery bypass graft (CABG) surgery. This sub-study assessed SVGs with and without external stenting using optical coherence tomography (OCT). The aim of this study was to accurately compare quantitative and qualitative features of SVGs with and without a novel external stent using OCT.
Plasma homocysteine levels are related to medium-term venous graft degeneration in coronary artery bypass graft patients. [2018]Saphenous venous grafts (SVGs) are established choices for coronary artery bypass grafting (CABG); however, their lumen patency is limited. Our goal was to investigate the risk factors of SVG degeneration.
Storage solutions to improve grafts preservation and longevity in coronary artery bypass grafting surgery: hype or hope? [2023]Saphenous vein grafts (SVGs) remain the most-commonly used conduits for coronary artery bypass grafting (CABG).Significant rates of vein graft failure (VGF) remain a limitation of their use as this diminishes the long-term benefits of CABG. The choice of intraoperative SVGs preservation solution is believed to have an impact on graft patency; however, the superiority of one solution over the others remains in question.
[Findings of optical coherence tomography in saphenous grafts failure. Report of one case]. [2022]Atherosclerosis is the main cause of late saphenous vein graft (SVG) failure. Intracoronary images using optical coherence tomography (OCT) in addition to angiography allow a detailed analysis of the lesion beyond the degree of stenosis. We report a 67 years old diabetic male who underwent coronary surgery in 2009, consulting for an acute coronary syndrome. Angiography showed two different lesions on one aortocoronary venous grafts. OCT demonstrates atherosclerosis in different stages identifying the culprit lesion. Stent placement were successfully carried out.