OCT-Guided Coronary Bypass Grafting for Graft Failure

(OCTOCAB Trial)

Overseen By Elizabeth S. Haag, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: St. Francis Hospital, New York

Must not be taking: Aspirin, P2Y12 inhibitors

Disqualifiers: STEMI, CHF, LVEF <30%, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Surgery duration

760 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether using Optical Coherence Tomography (OCT) during heart bypass surgery can prevent early failure of vein grafts. Participants will have vein grafts guided either by OCT or by regular visual inspection. The trial seeks individuals with heart issues, such as chest pain or past heart attacks, who are scheduled for bypass surgery. Participants must have a diagnosis that makes them suitable for this type of surgery.

As an unphased trial, this study provides participants the chance to contribute to innovative research that could enhance surgical outcomes for future patients.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have a known allergy or cannot take any of the study drugs like aspirin or P2Y12 inhibitors, you may not be eligible to participate.

What prior data suggests that this OCT-guided technique is safe for coronary bypass grafting?

Research has shown that using optical coherence tomography (OCT) during coronary artery bypass surgery holds promise for safety. OCT employs infrared light to create clear images of blood vessels, aiding surgeons in identifying any issues in the veins used for grafting.

Studies have found that OCT effectively selects healthy veins for surgery, reducing the risk of complications. Reports indicate that OCT is generally well-tolerated, with no major safety concerns during surgeries.

The technology primarily provides a clearer view of the veins, ensuring the selection of only healthy ones for grafting. This could lead to better surgical outcomes. Thus, OCT-guided procedures might offer a safer option by avoiding the use of damaged veins. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the use of Optical Coherence Tomography (OCT) in coronary artery bypass graft surgery, offering a potentially game-changing approach to reducing graft failure. Traditional procedures rely on visual inspection of the saphenous vein conduits, but OCT uses infrared light to create high-quality images of the veins, allowing for a more precise assessment. This technique enables surgeons to detect abnormalities that might not be visible to the naked eye, potentially leading to better outcomes by ensuring only the healthiest veins are used. By refining the selection of graft materials, OCT-guided surgery could significantly enhance the success rates of coronary bypass procedures.

What evidence suggests that OCT-guided saphenous vein CABG is effective for reducing early vein graft failure?

Studies have shown that using Optical Coherence Tomography (OCT) during coronary artery bypass surgery can improve results. OCT employs infrared light to create detailed images of blood vessels. In this trial, one group will undergo OCT-guided saphenous vein graft coronary artery bypass graft surgery, using OCT to better identify issues in the veins used for grafts, potentially reducing early graft failure. Another group will have visual inspection-guided saphenous vein graft surgery, where veins are assessed visually. Research indicates that OCT-guided procedures can be more effective than visual inspection alone. Initial findings are promising, showing that OCT can help select healthier veins, potentially leading to fewer complications after surgery. ^{1 2 3 6 7}

Who Is on the Research Team?

Ziad A. Ali, MD, DPhil

Principal Investigator

Saint Francis Hospital

Edward F. Lundy, MD, PhD

Principal Investigator

Saint Francis Hospital

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

I have heart issues that may require bypass surgery.

I have a heart blockage that can be treated with a vein graft.

Exclusion Criteria

I am undergoing or have undergone surgery on multiple heart valves or the main artery coming from my heart.

I have had coronary artery bypass surgery.

Life expectancy <2 years for any non-cardiac cause

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo coronary artery bypass graft surgery with either OCT-guided or visual inspection-guided saphenous vein grafting

Surgery duration

1 visit (in-person)

Follow-up

Participants are monitored for vein graft failure and other outcomes using coronary CT angiogram and other assessments

12 months

Regular follow-up visits as needed

Long-term follow-up

Participants are followed for up to 10 years to assess long-term outcomes and vein graft patency

Up to 10 years

What Are the Treatments Tested in This Trial?

Interventions

• OCT-guided saphenous vein CABG

Trial Overview 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.

How Is the Trial Designed?

Group I: OCT-guided saphenous vein graft coronary artery bypass graft surgery Experimental Treatment 1 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 surgery Active Control 1 Intervention

Harvested saphenous vein conduits will be assessed visually and will undergo a blinded OCT.

OCT-guided saphenous vein CABG is already approved in European Union, United States for the following indications:

Approved in European Union as OCT-Guided SV CABG for:

• Coronary artery bypass grafting
• Assessment of saphenous vein grafts

Approved in United States as OCT-Guided SV CABG for:

• Coronary artery bypass grafting
• Evaluation of saphenous vein grafts

Who Is Running the Clinical Trial?

St. Francis Hospital, New York

Lead Sponsor

Trials

9

Recruited

2,300+

Published Research Related to This Trial

Optical coherence tomography (OCT) provides a detailed analysis of atherosclerosis in saphenous vein grafts, revealing lesions that may not be apparent through angiography alone.

In a case study of a 67-year-old diabetic male, OCT successfully identified the culprit lesion in a graft, leading to effective stent placement and treatment of acute coronary syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Findings of optical coherence tomography in saphenous grafts failure. Report of one case]. Pérez, L., Venegas, R., Ibieta, G., et al.[2022]

In a study of 75 patients with 133 saphenous venous grafts (SVGs) followed for an average of 67.6 months after coronary artery bypass grafting (CABG), elevated plasma homocysteine (Hcy) levels were significantly associated with SVG degeneration, particularly in narrowed grafts.

The research found that for every 1 µmol/L increase in Hcy, there was a corresponding 0.053% per month decrease in graft lumen diameter, suggesting that higher Hcy levels can lead to significant long-term reductions in graft patency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plasma homocysteine levels are related to medium-term venous graft degeneration in coronary artery bypass graft patients. Balogh, E., Maros, T., Daragó, A., et al.[2018]

Sequential saphenous vein grafts (SVGs) show significantly higher long-term patency rates (82%) compared to individual SVGs (68%) in coronary bypass procedures, based on an analysis of 875 anastomoses in 430 patients over an average of 5.8 years.

The benefits of sequential grafts are especially notable in cases with poor-quality coronary arteries, where the patency rate for sequential grafts is 57% compared to just 28% for individual grafts, highlighting the importance of grafting techniques and vessel characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term patency of sequential and individual saphenous vein coronary bypass grafts. Vural, KM., Sener, E., Taşdemir, O.[2019]

Saphenous vein grafts (SVGs) are commonly used in coronary artery bypass grafting (CABG), but their long-term success is limited by significant rates of vein graft failure (VGF).

The choice of storage solution for SVGs affects their structure and function, yet there is currently no clear evidence supporting the superiority of any specific solution, highlighting the need for further research to guide clinical practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Storage solutions to improve grafts preservation and longevity in coronary artery bypass grafting surgery: hype or hope? Eqbal, A., Gupta, S., Bisleri, G.[2023]

In a study of 49,325 older patients (median age 75) with failing saphenous vein grafts, those treated with drug-eluting stents (DES) had a significantly lower 3-year mortality rate (22.7%) compared to those treated with bare metal stents (BMS) (28.0%).

There was no significant difference in the rates of myocardial infarction or urgent revascularization between DES and BMS patients, indicating that DES may be a safer option without compromising other important clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and clinical effectiveness of drug-eluting stents for saphenous vein graft intervention in older individuals: Results from the medicare-linked National Cardiovascular Data Registry(®) CathPCI Registry(®) (2005-2009). Brennan, JM., Sketch, MH., Dai, D., et al.[2017]

Optical coherence tomography (OCT) revealed that atherosclerotic lesions in saphenous vein grafts (SVGs) of patients with acute coronary syndromes (ACS) are predominantly fibrofatty, with significant occurrences of plaque rupture (60.7%) and thrombus (46.4%), indicating complex lesion characteristics.

The study, which included 28 SVGs from 26 patients, found that the presence of thrombus increased with the severity of ACS, suggesting that similar pathological mechanisms may be at play in SVGs as in native coronary arteries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of culprit saphenous vein graft lesions with optical coherence tomography in patients with acute coronary syndromes. Davlouros, P., Damelou, A., Karantalis, V., et al.[2022]

Saphenous vein grafts (SVG) are commonly used in coronary bypass surgery but face significant long-term issues, with nearly 50% developing serious narrowing and 40% becoming completely blocked within ten years.

Current treatment options for SVG failure, such as redo-surgery and percutaneous interventions, come with risks like complications and reduced graft success, highlighting the need for improved strategies to maintain graft patency and enhance patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Saphenous vein graft disease: causes, prevention, and contemporary treatment strategies]. Gökay, S., Ciçek, D.[2018]

In a study of 182 post-CABG patients, those with saphenous vein graft (SVG) markers experienced significantly shorter procedure times, less fluoroscopy time, and reduced contrast use during cardiac catheterization, indicating improved efficiency.

The use of SVG markers not only enhances procedural efficiency but also minimizes patient and physician exposure to ionizing radiation and potentially harmful contrast agents, making them beneficial for most post-CABG patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Value of saphenous vein graft markers during subsequent diagnostic cardiac catheterization. Peterson, LR., McKenzie, CR., Ludbrook, PA., et al.[2022]

In a study of 24 patients who underwent coronary artery bypass graft surgery, external stenting of saphenous vein grafts (SVGs) resulted in a more uniform and circular lumen compared to unstented grafts, which may help reduce the risk of graft failure.

No thrombus formation was observed in the stented grafts, while adherent thrombus was found in three unstented grafts, suggesting that external stenting may enhance the safety and efficacy of SVGs post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

OCT imaging of aorto-coronary vein graft pathology modified by external stenting: 1-year post-surgery. Webb, CM., Orion, E., Taggart, DP., et al.[2017]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05129228

Optical Coherence Tomography of the Saphenous Vein ... This study is designed to demonstrate the superiority of OCT-guided saphenous vein CABG in improving the rates of early VGF and the overall outcome of CABG. The ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05129228?term=ilumien&viewType=Table&rank=7

Optical Coherence Tomography of the Saphenous Vein Graft This study is designed to demonstrate the superiority of OCT-guided saphenous vein CABG in improving the rates of early VGF and the overall outcome of CABG. The ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2962582/

Thinking inside the graft: Applications of optical coherence ... We demonstrate the feasibility of OCT imaging as an intraoperative tool to select conduit vessels for CABG.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6041839/

Saphenous graft atherosclerosis as assessed by optical ... Coronary artery bypass grafting (CABG), although ... Data derived from optical coherence tomography analysis of saphenous vein grafts.

5. internationalcoronarycongress.com internationalcoronarycongress.com/program/2024/assets/P4.pdf

Conclusion Intraoperative Optical Coherence Tomography ... This Pilot study justified development of a large blinded randomized trial to determine if OCT can reduce incidence of early vein graft closure. That study is ...

6. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.120.052163

Saphenous Vein Graft Failure: From Pathophysiology to ... After a mean follow-up of 16 years, SVG patency was higher with the no-touch technique (83% versus 64%, P=0.03). The SUPERIOR SVG trial ( ...

7. annalsthoracicsurgery.org annalsthoracicsurgery.org/article/S0003-4975(22)01109-2/fulltext

Visualizing Inside Conduits—Intraoperative Screening ... We describe a new technique for intraoperative acquisition of OCT images in the harvested SVGs and introduce a classification system for pathologic processes.