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Imaging Device

OCT-Guided Coronary Bypass Grafting for Graft Failure (OCTOCAB Trial)

N/A
Recruiting
Led By Ziad A. Ali, MD,DPhil
Research Sponsored by St. Francis Hospital, New York
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject must have evidence of myocardial ischemia suitable for elective CABG (e.g., stable angina, silent ischemia, unstable angina, or acute myocardial infarction)
Subject must be at least 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

OCTOCAB Trial 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.

Who is the study for?
This trial is for adults with myocardial ischemia suitable for elective coronary artery bypass grafting (CABG) who can consent to the study. Excluded are those with severe heart failure, recent STEMI, significant kidney dysfunction, unstable arrhythmias, prior CABG, extreme platelet counts, liver disease, short life expectancy due to non-cardiac causes or conditions that could affect participation or results.Check my eligibility
What is being tested?
The OCTOCAB trial tests if using intravascular optical coherence tomography (OCT) during saphenous vein grafting in CABG surgery can lower early vein graft failure rates. It's a prospective study where participants are randomly assigned to receive either the standard procedure or the OCT-guided technique.See study design
What are the potential side effects?
While specific side effects of OCT-guided CABG aren't detailed here, typical risks may include bleeding at the surgical site, infection risk from incisions and potential reactions to contrast agents used during imaging.

OCTOCAB Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have heart issues that may require bypass surgery.
Select...
I am 18 years old or older.
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I have a heart blockage that can be treated with a vein graft.

OCTOCAB Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Vein graft failure (VGF)
Secondary outcome measures
All Myocardial Infarction (MI)
All revascularization
All-cause mortality
+13 more
Other outcome measures
Immunohistochemistry
Intimal injury
Intraluminal mass
+5 more

OCTOCAB Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: OCT-guided saphenous vein graft coronary artery bypass graft surgeryExperimental Treatment1 Intervention
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.
Group II: Visual inspection-guided saphenous vein graft coronary artery graft surgeryActive Control1 Intervention
Harvested saphenous vein conduits will be assessed visually and will undergo a blinded OCT.

Find a Location

Who is running the clinical trial?

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

Media Library

OCT-guided saphenous vein CABG (Imaging Device) Clinical Trial Eligibility Overview. Trial Name: NCT05129228 — N/A
Coronary Bypass Graft Stenosis Research Study Groups: OCT-guided saphenous vein graft coronary artery bypass graft surgery, Visual inspection-guided saphenous vein graft coronary artery graft surgery
OCT-guided saphenous vein CABG (Imaging Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05129228 — N/A
Coronary Bypass Graft Stenosis Clinical Trial 2023: OCT-guided saphenous vein CABG Highlights & Side Effects. Trial Name: NCT05129228 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the cohort size for this clinical trial?

"Yes, the information on clinicaltrials.gov conclusively indicates that this research project is currently recruiting participants. The trial was first posted on April 4th 2022 and its most recent update occurred May 4th 2022 - with a total of 760 individuals sought from one medical centre."

Answered by AI

Is this clinical investigation currently open to participants?

"According to clinicaltrials.gov, this medical trial is seeking participants and has been updated as recently as May 4th 2022. The experiment was first posted on April 4th of the same year."

Answered by AI
Recent research and studies
~0 spots leftby Apr 2024