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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Subject must be at least 18 years of age.

• 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.

• Subject must have undergone coronary angiography identifying at least one lesion that is clinically appropriate and suitable for saphenous vein bypass grafting.

• Subject must provide written Informed Consent prior to any study related procedure.

Locations
United States
New York
St Francis Hospital
RECRUITING
Roslyn
Contact Information
Primary
Ziad A. Ali, MD,DPhil
ziadali.mail@gmail.com
516-622-4552
Backup
Elizabeth S. Haag, RN
Elizabeth.Haag@chsli.org
516-622-4552
Time Frame
Start Date: 2022-04-04
Estimated Completion Date: 2026-04-04
Participants
Target number of participants: 760
Treatments
Experimental: OCT-guided saphenous vein graft coronary artery bypass graft surgery
Optical Coherence Tomography (OCT) provides high quality intravascular images by using infrared light. OCT will assess the harvested saphenous vein conduit in Coronary Bypass Graft Surgery (CABG). Abnormalities found in the harvested conduits via OCT, at the discretion of the surgeon, will not be utilized for CABG.
No_intervention: Visual inspection-guided saphenous vein graft coronary artery graft surgery
Harvested saphenous vein conduits will be assessed visually and will undergo a blinded OCT.
Related Therapeutic Areas
Sponsors
Leads: St. Francis Hospital, New York

This content was sourced from clinicaltrials.gov