Last updated: May 4, 2022
Sponsor: St. Francis Hospital, New York
Overall Status: Active - Recruiting
Phase
N/A
Condition
N/ATreatment
N/AClinical Study ID
NCT05129228
21-10
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Subject must be at least 18 years of age.
- Subject must have evidence of myocardial ischemia (e.g., stable angina, silentischemia (ischemia in the absence of chest pain or other anginal equivalents),unstable angina, or acute myocardial infarction) suitable for elective CABG.
- Subject must have undergone coronary angiography identifying at least one lesion thatis clinically appropriate and suitable for saphenous vein bypass grafting.
- Subject must provide written Informed Consent prior to any study related procedure.
Exclusion
Exclusion Criteria:
- STEMI ≤24 hours from the onset of ischemic symptoms
- Creatinine clearance ≤30 ml/min/1.73 m2 (as calculated by MDRD formula for estimatedGFR) and not on dialysis.
- Hypotension, shock or need for mechanical support or intravenous vasopressors at thetime that the patient would be undergoing the index procedure.
- CHF (Killip class >2 or NYHA class >3)
- LVEF <30% by the most recent imaging test within 6 months prior to procedure. If noLVEF test result within 6 months is available, it must be assessed byechocardiography, multiple gated acquisition (MUGA), magnetic resonance imaging (MRI),ventriculography (LV gram) or other method.
- Unstable ventricular arrhythmias
- Concomitant multi-valve surgery or major aortic root surgery.
- Planned non-cardiac surgery within 24 months after the index procedure
- Prior CABG
- Any planned PCI within any target vessel(s) within 24 months.
- Subject has known hypersensitivity or contraindication to any of the study drugs (including aspirin, all P2Y12 inhibitors).
- Subject has received a heart transplant.
- Subject is receiving immunosuppressant therapy or has known immunosuppressive orsevere autoimmune disease that requires chronic immunosuppressive therapy (e.g., humanimmunodeficiency virus, systemic lupus erythematosus, etc.).
- Subject has previously received or is scheduled to receive radiotherapy to a coronaryartery (vascular brachytherapy), or the chest/mediastinum.
- Subject has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3.
- Subject has a documented or suspected hepatic disorder as defined as cirrhosis orChild-Pugh ≥ Class B.
- Subject has a history of bleeding diathesis or coagulopathy.
- Subject has life expectancy <2 years for any non-cardiac cause.
- Pregnant or nursing subjects and those who plan pregnancy in the period up to 2 yearsfollowing index procedure. Female subjects of child-bearing potential must have anegative pregnancy test done within 7 days prior to the index procedure per sitestandard test.
- Presence of other anatomic or comorbid conditions, or other medical, social, orpsychological conditions that, in the investigator's opinion, could limit thesubject's ability to participate in the clinical investigation or to comply withfollow-up requirements, or impact the scientific soundness of the clinicalinvestigation results. Conduit exclusion criteria
- Severe conduit tortuosity of venous conduit (e.g., with varicosities) such that it isunlikely that the OCT catheter can be delivered without vascular damage.
Study Design
Total Participants: 760
Study Start date:
April 04, 2022
Estimated Completion Date:
April 04, 2026
Study Description
Connect with a study center
St Francis Hospital
Roslyn, New York 11576
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.