Optical Coherence Tomography of the Saphenous Vein Graft
NCT05129228 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 760
Last updated 2022-05-05
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).
Conditions
- Coronary Bypass Graft Stenosis
Interventions
- DEVICE
-
OCT-guided saphenous vein CABG
OCT examination of harvested saphenous vein conduits will indicate pathology. Under the surgeon's discretion the conduit segments with pathology will not be grafted.
Sponsors & Collaborators
-
St. Francis Hospital, New York
lead OTHER
Principal Investigators
-
Ziad A. Ali, MD,DPhil · Saint Francis Hospital
-
Edward F. Lundy, MD, PhD · Saint Francis Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-04-04
- Primary Completion
- 2024-04-04
- Completion
- 2026-04-04
- FDA Device
- Yes
Countries
- United States
Study Locations
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