Clinical trial NCT05129228: Optical Coherence Tomography of the Saphenous Vein Graft
Official title: Intraoperative Optical Coherence Tomography of the Saphenous Vein Conduit in Patients Undergoing Coronary Artery Bypass Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: St. Francis Hospital, New York
Sponsor class: OTHER
First posted: 2021-11-22
Enrollment: 760
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: OCT-guided saphenous vein CABG
Primary purpose: TREATMENT

Brief 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).

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.

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.

Primary outcomes:
measure: Vein graft failure (VGF)
timeFrame: 12 months
Secondary outcomes:
measure: Target graft failure (TGF)
timeFrame: 12 months
measure: Per graft incidence of ischemic vein graft failure
timeFrame: 12 months
measure: Per graft incidence anatomic vein graft failure
timeFrame: 12 months
measure: Per patient incidence of vein graft patency
timeFrame: 12 months
measure: Per patient incidence of ischemic vein graft failure
timeFrame: 12 months
measure: Per patient incidence of anatomic vein graft failure
timeFrame: 12 months
measure: Mean vein graft diameter stenosis
timeFrame: 12 months
measure: Mean vein graft area stenosis
timeFrame: 12 months
measure: All-cause mortality
timeFrame: 12 months
measure: Cardiac and non-cardiac mortality
timeFrame: 12 months
measure: All Myocardial Infarction (MI)
timeFrame: 12 months
measure: Target graft myocardial infarction (TG-MI) and Non-Target graft myocardial infarction (non-TG-MI)
timeFrame: 12 months
measure: All revascularization
timeFrame: 12 months
measure: Ischemia driven (ID)-revascularization and Non-ischemia driven (ID)-revascularization
timeFrame: 12 months
measure: Ischemia driven-target graft failure (ID-TGR)
timeFrame: 12 months
measure: Ischemia driven (ID)-revascularization of target native coronary artery subtended by the graft
timeFrame: 12 months
Other outcomes:
measure: Intimal injury
timeFrame: 12 months
measure: Intraluminal mass
timeFrame: 12 months
measure: Intramural hematoma
timeFrame: 12 months
measure: Valvular sclerosis
timeFrame: 12 months
measure: Immunohistochemistry
timeFrame: 12 months
measure: Transit-Time Flow Meter (TTFM)
timeFrame: 12 months
measure: Relationship between OCT parameters and endpoint rates
timeFrame: 12 months
measure: Relationship between OCT parameters at baseline in the standard of care arm with OCT findings in vivo during follow-up
timeFrame: 12 months
Locations:
city: Roslyn
country: United States
facility: St Francis Hospital
state: New York
Study officials:
affiliation: Saint Francis Hospital
name: Ziad A. Ali, MD,DPhil
role: PRINCIPAL_INVESTIGATOR
affiliation: Saint Francis Hospital
name: Edward F. Lundy, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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