OCT-guided saphenous vein CABG for Coronary Bypass Graft Stenosis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Coronary Bypass Graft StenosisOCT-guided saphenous vein CABG - Device
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial will compare optical coherence tomography-guided saphenous vein grafting to the standard of care in coronary artery bypass surgery to see if it reduces the rate of early vein graft failure.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 16 Secondary · Reporting Duration: 12 months

12 months
All Myocardial Infarction (MI)
All revascularization
All-cause mortality
Cardiac and non-cardiac mortality
Immunohistochemistry
Intimal injury
Intraluminal mass
Intramural hematoma
Ischemia driven (ID)-revascularization and Non-ischemia driven (ID)-revascularization
Ischemia driven (ID)-revascularization of target native coronary artery subtended by the graft
Ischemia
Mean vein graft area stenosis
Mean vein graft diameter stenosis
Per graft incidence anatomic vein graft failure
Per graft incidence of ischemic vein graft failure
Per patient incidence of anatomic vein graft failure
Per patient incidence of ischemic vein graft failure
Per patient incidence of vein graft patency
Relationship between OCT parameters and endpoint rates
Relationship between OCT parameters at baseline in the standard of care arm with OCT findings in vivo during follow-up
Target graft failure (TGF)
Target graft myocardial infarction (TG-MI) and Non-Target graft myocardial infarction (non-TG-MI)
Transit-Time Flow Meter (TTFM)
Valvular sclerosis
Vein graft failure (VGF)

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Visual inspection-guided saphenous vein graft coronary artery graft surgery
1 of 2
OCT-guided saphenous vein graft coronary artery bypass graft surgery
1 of 2

Active Control

Experimental Treatment

760 Total Participants · 2 Treatment Groups

Primary Treatment: OCT-guided saphenous vein CABG · No Placebo Group · N/A

OCT-guided saphenous vein graft coronary artery bypass graft surgery
Device
Experimental Group · 1 Intervention: OCT-guided saphenous vein CABG · Intervention Types: Device
Visual inspection-guided saphenous vein graft coronary artery graft surgeryNoIntervention Group · 1 Intervention: Visual inspection-guided saphenous vein graft coronary artery graft surgery · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months

Who is running the clinical trial?

St. Francis Hospital, New YorkLead Sponsor
8 Previous Clinical Trials
1,555 Total Patients Enrolled
Edward F. Lundy, MD, PhDPrincipal InvestigatorSaint Francis Memorial Hospital
Ziad A. Ali, MD,DPhilPrincipal InvestigatorSaint Francis Memorial Hospital

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Subjects must have evidence of myocardial ischemia (e.g.
You must provide written informed consent prior to any study related procedure.
References