Using advanced imaging to improve saphenous vein grafts in heart surgery

Intraoperative Optical Coherence Tomography of the Saphenous Vein Conduit in Patients Undergoing Coronary Artery Bypass Surgery

This study is testing if using advanced imaging during heart surgery can help improve the success of vein grafts for people having coronary artery bypass surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 760 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: St. Francis Hospital, New York (Academic / other)
• Locations: 1 site (Roslyn, New York)
• Trial ID: NCT05129228 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate whether using intravascular optical coherence tomography (OCT) during coronary artery bypass grafting (CABG) can reduce the rate of early vein graft failure. Participants will be randomly assigned to receive either OCT-guided saphenous vein grafting or standard visual inspection-guided grafting. The study will follow participants for up to 10 years, assessing the condition of the grafts primarily through coronary CT angiograms at 12 months. The goal is to demonstrate that OCT can provide better insights into vein quality, potentially leading to improved surgical outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with evidence of myocardial ischemia suitable for elective CABG.

Not a fit: Patients with recent STEMI, severe renal impairment, or significant heart failure may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly lower the incidence of early vein graft failure, improving patient outcomes after heart surgery.

How similar studies have performed: While the use of OCT in this specific context is novel, similar imaging techniques have shown promise in improving outcomes in other vascular procedures.

Eligibility criteria

Inclusion Criteria:

1. Subject must be at least 18 years of age.
2. 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.
3. Subject must have undergone coronary angiography identifying at least one lesion that is clinically appropriate and suitable for saphenous vein bypass grafting.
4. Subject must provide written Informed Consent prior to any study related procedure.

Exclusion Criteria:

1. STEMI ≤24 hours from the onset of ischemic symptoms
2. Creatinine clearance ≤30 ml/min/1.73 m2 (as calculated by MDRD formula for estimated GFR) and not on dialysis.
3. Hypotension, shock or need for mechanical support or intravenous vasopressors at the time that the patient would be undergoing the index procedure.
4. CHF (Killip class \>2 or NYHA class \>3)
5. 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.
6. Unstable ventricular arrhythmias
7. Concomitant multi-valve surgery or major aortic root surgery.
8. Planned non-cardiac surgery within 24 months after the index procedure
9. Prior CABG
10. Any planned PCI within any target vessel(s) within 24 months.
11. Subject has known hypersensitivity or contraindication to any of the study drugs (including aspirin, all P2Y12 inhibitors).
12. Subject has received a heart transplant.
13. 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.).
14. Subject has previously received or is scheduled to receive radiotherapy to a coronary artery (vascular brachytherapy), or the chest/mediastinum.
15. Subject has a platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3.
16. Subject has a documented or suspected hepatic disorder as defined as cirrhosis or Child-Pugh ≥ Class B.
17. Subject has a history of bleeding diathesis or coagulopathy.
18. Subject has life expectancy \<2 years for any non-cardiac cause.
19. 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.
20. 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.

Where this trial is running

Roslyn, New York

• St Francis Hospital — Roslyn, New York, United States (Recruiting)

Study contacts

• Principal investigator: Ziad A. Ali, MD,DPhil — Saint Francis Hospital
• Study coordinator: Ziad A. Ali, MD,DPhil

Conditions Coronary Bypass Graft Stenosis; Coronary Artery Bypass Surgery; Saphenous Vein Graft; Intravascular Optical Coherence Tomography; Vein Graft Failure; Coronary Computed Tomography Angiography; Coronary Artery Disease