What is the mechanism of action of this treatment?

Common treatments for Coronary Bypass Graft Stenosis include percutaneous coronary interventions (PCI) such as balloon angioplasty and stenting, as well as surgical revascularization. Balloon angioplasty works by inflating a small balloon inside the narrowed graft to widen it, while stenting involves placing a mesh tube to keep the graft open. These treatments restore blood flow and reduce symptoms like chest pain. Intravascular Optical Coherence Tomography (OCT) is a high-resolution imaging technique that helps in precisely assessing and placing grafts, potentially reducing the risk of early graft failure. This is crucial for patients as it improves the long-term success of the graft and overall cardiovascular outcomes.

What side effects are associated with this type of intervention?

Common treatments for Coronary Bypass Graft Stenosis, such as coronary artery bypass grafting (CABG), can have several side effects including infection, bleeding, arrhythmias, and complications related to anesthesia. When using intravascular optical coherence tomography (OCT) to guide saphenous vein grafting, additional side effects may include vessel injury due to the imaging catheter, contrast-induced nephropathy from the use of contrast agents, and potential allergic reactions. OCT aims to improve graft placement and assessment, potentially reducing some complications, but the procedure itself carries risks associated with the invasive nature of the imaging technique.

What prior FDA approvals exist?

The FDA has approved several treatments for Coronary Bypass Graft Stenosis, including the use of high-resolution imaging techniques like Intravascular Ultrasound (IVUS) and Optical Coherence Tomography (OCT). These imaging modalities are used to improve the precision of graft placement and to assess the condition of the grafts post-surgery. OCT, in particular, provides detailed images of the vessel walls, helping to identify issues such as intimal hyperplasia and graft occlusion, thereby guiding interventions to improve graft patency and patient outcomes.

What other types of research exist?

Promising alternatives to Intravascular Optical Coherence Tomography (OCT) for saphenous vein grafting in coronary bypass graft stenosis patients include: 1) Intravascular Ultrasound (IVUS), which provides detailed images of the vessel wall and can help in precise graft placement. 2) Near-Infrared Spectroscopy (NIRS), which can identify lipid-rich plaques and assess the risk of graft failure. 3) Fractional Flow Reserve (FFR) measurement, which evaluates the physiological impact of stenosis and guides treatment decisions. These technologies offer high-resolution imaging and functional assessment, potentially improving outcomes for patients.

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Imaging Device

OCT-Guided Coronary Bypass Grafting for Graft Failure (OCTOCAB Trial)

N/A

Recruiting

Led By Edward F. Lundy, MD, PhD

Research Sponsored by St. Francis Hospital, New York

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject must have evidence of myocardial ischemia suitable for elective CABG (e.g., stable angina, silent ischemia, unstable angina, or acute myocardial infarction)

Subject must be at least 18 years of age

Must not have

Concomitant multi-valve surgery or major aortic root surgery

Prior CABG

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects of OCT-guided CABG aren't detailed here, typical risks may include bleeding at the surgical site, infection risk from incisions and potential reactions to contrast agents used during imaging.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have heart issues that may require bypass surgery.

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I am 18 years old or older.

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I have a heart blockage that can be treated with a vein graft.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am undergoing or have undergone surgery on multiple heart valves or the main artery coming from my heart.

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I have had coronary artery bypass surgery.

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My heart failure is not severe (below Killip class 3 or NYHA class 4).

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I am on long-term medication to suppress my immune system due to severe autoimmune disease.

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I have had a heart transplant.

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I do not have irregular heartbeats that are severe and uncontrolled.

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I had a severe heart attack less than 24 hours ago.

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My kidney function is low, but I am not on dialysis.

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I do not need machines or IV drugs to maintain my blood pressure.

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I am scheduled for a heart artery procedure within the next 2 years.

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I have a history of bleeding disorders.

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I am allergic or react badly to the drugs used in this study.

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I have had or will have radiation therapy to my heart area or chest.

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I have a liver condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Vein graft failure (VGF)

Secondary study objectives

Per graft incidence anatomic vein graft failure

Per graft incidence of ischemic vein graft failure

Per patient incidence of anatomic vein graft failure

+3 more

Other study objectives

Immunohistochemistry

Intimal injury

Intraluminal mass

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 17Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Coronary Bypass Graft Stenosis include percutaneous coronary interventions (PCI) such as balloon angioplasty and stenting, as well as surgical revascularization. Balloon angioplasty works by inflating a small balloon inside the narrowed graft to widen it, while stenting involves placing a mesh tube to keep the graft open. These treatments restore blood flow and reduce symptoms like chest pain. Intravascular Optical Coherence Tomography (OCT) is a high-resolution imaging technique that helps in precisely assessing and placing grafts, potentially reducing the risk of early graft failure. This is crucial for patients as it improves the long-term success of the graft and overall cardiovascular outcomes.