RECRUITING

Optical Coherence Tomography of the Saphenous Vein Graft

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2022-04-04

Study Completion:2026-04-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05129228

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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. 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.

Inclusion Criteria

Exclusion 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.

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.
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.

Contacts and Locations

Study Contact

Ziad A. Ali, MD,DPhil

CONTACT

516-622-4552

ziadali.mail@gmail.com

Elizabeth S. Haag, RN

CONTACT

516-622-4552

Elizabeth.Haag@chsli.org

Principal Investigator

Ziad A. Ali, MD,DPhil

PRINCIPAL_INVESTIGATOR

Saint Francis Hospital

Edward F. Lundy, MD, PhD

PRINCIPAL_INVESTIGATOR

Saint Francis Hospital

Study Locations (Sites)

St Francis Hospital

Roslyn, New York, 11576

United States

Collaborators and Investigators

Sponsor: St. Francis Hospital, New York

Ziad A. Ali, MD,DPhil, PRINCIPAL_INVESTIGATOR, Saint Francis Hospital
Edward F. Lundy, MD, PhD, PRINCIPAL_INVESTIGATOR, Saint Francis Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-04

Study Completion Date2026-04-04

Study Record Updates

Study Start Date2022-04-04

Study Completion Date2026-04-04

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Coronary Bypass Graft Stenosis