Optical Coherence Tomography of the Saphenous Vein Graft

NCT05129228 | Recruiting FDA Device

• 1 other identifier: 21-10
• Study Type: interventional
• Target: 760
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Coronary Artery Bypass Surgery; Saphenous Vein Graft; Intravascular Optical Coherence Tomography; Vein Graft Failure; Coronary Computed Tomography Angiography; Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Vein graft failure (VGF)

  Per graft incidence of VGF defined as greater than or equal to 70% in the body of the graft on coronary CT angiography (CCTA)

  12 months

Secondary Outcomes (16)

• Target graft failure (TGF)

  12 months

• Per graft incidence of ischemic vein graft failure

  12 months

• Per graft incidence anatomic vein graft failure

  12 months

• Per patient incidence of vein graft patency

  12 months

• Per patient incidence of ischemic vein graft failure

  12 months

Other Outcomes (8)

• Intimal injury

  12 months

• Intraluminal mass

  12 months

• Intramural hematoma

  12 months

Study Arms (2)

OCT-guided saphenous vein graft coronary artery bypass graft surgery

EXPERIMENTAL

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.

Device: OCT-guided saphenous vein CABG

Visual inspection-guided saphenous vein graft coronary artery graft surgery

NO INTERVENTION

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

Interventions

OCT-guided saphenous vein CABG DEVICE

OCT examination of harvested saphenous vein conduits will indicate pathology. Under the surgeon's discretion the conduit segments with pathology will not be grafted.

Also known as: ILUMIEN OPTIS NEXT OCT Imaging System, ILUMIEN OPTIS OCT Imaging System, OPTIS Integrated OCT Imaging System, OPTIS Mobile OCT Imaging System, Dragonfly Duo Catheter, Dragonfly OPTIS Catheter, Dragonfly OpStar Imaging Catheter, Dual Channel AureFlo Systems, Coronary Flowprobes

OCT-guided saphenous vein graft coronary artery bypass graft surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• STEMI ≤24 hours from the onset of ischemic symptoms
• Creatinine clearance ≤30 ml/min/1.73 m2 (as calculated by MDRD formula for estimated GFR) and not on dialysis.
• Hypotension, shock or need for mechanical support or intravenous vasopressors at the time that the patient would be undergoing the index procedure.
• CHF (Killip class \>2 or NYHA class \>3)
• LVEF \<30% by the most recent imaging test within 6 months prior to procedure. If no LVEF test result within 6 months is available, it must be assessed by echocardiography, multiple gated acquisition (MUGA), magnetic resonance imaging (MRI), ventriculography (LV gram) or other method.
• Unstable ventricular arrhythmias
• Concomitant multi-valve surgery or major aortic root surgery.
• Planned non-cardiac surgery within 24 months after the index procedure
• Prior CABG
• Any planned PCI within any target vessel(s) within 24 months.
• Subject has known hypersensitivity or contraindication to any of the study drugs (including aspirin, all P2Y12 inhibitors).
• Subject has received a heart transplant.
• Subject is receiving immunosuppressant therapy or has known immunosuppressive or severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.).
• Subject has previously received or is scheduled to receive radiotherapy to a coronary artery (vascular brachytherapy), or the chest/mediastinum.
• Subject has a platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3.

Sponsors & Collaborators

• St. Francis Hospital, New York: lead

Study Sites (1)

St Francis Hospital

Roslyn, New York, 11576, United States

RECRUITING

Related Publications (10)

• Antonopoulos AS, Odutayo A, Oikonomou EK, Trivella M, Petrou M, Collins GS, Antoniades C; SAFINOUS-CABG (Saphenous Vein Graft Failure-An Outcomes Study in Coronary Artery Bypass Grafting) group. Development of a risk score for early saphenous vein graft failure: An individual patient data meta-analysis. J Thorac Cardiovasc Surg. 2020 Jul;160(1):116-127.e4. doi: 10.1016/j.jtcvs.2019.07.086. Epub 2019 Aug 26.

  PMID: 31606176 BACKGROUND

• Gaudino M, Di Franco A, Bhatt DL, Alexander JH, Abbate A, Azzalini L, Sandner S, Sharma G, Rao SV, Crea F, Fremes SE, Bangalore S. The association between coronary graft patency and clinical status in patients with coronary artery disease. Eur Heart J. 2021 Apr 7;42(14):1433-1441. doi: 10.1093/eurheartj/ehab096.

  PMID: 33709098 BACKGROUND

• Caliskan E, de Souza DR, Boning A, Liakopoulos OJ, Choi YH, Pepper J, Gibson CM, Perrault LP, Wolf RK, Kim KB, Emmert MY. Saphenous vein grafts in contemporary coronary artery bypass graft surgery. Nat Rev Cardiol. 2020 Mar;17(3):155-169. doi: 10.1038/s41569-019-0249-3. Epub 2019 Aug 27.

  PMID: 31455868 BACKGROUND

• Tan ES, van der Meer J, Jan de Kam P, Dunselman PH, Mulder BJ, Ascoop CA, Pfisterer M, Lie KI. Worse clinical outcome but similar graft patency in women versus men one year after coronary artery bypass graft surgery owing to an excess of exposed risk factors in women. CABADAS. Research Group of the Interuniversity Cardiology Institute of The Netherlands. Coronary Artery Bypass graft occlusion by Aspirin, Dipyridamole and Acenocoumarol/phenoprocoumon Study. J Am Coll Cardiol. 1999 Nov 15;34(6):1760-8. doi: 10.1016/s0735-1097(99)00404-0.

  PMID: 10577567 BACKGROUND

• Fitzgibbon GM, Kafka HP, Leach AJ, Keon WJ, Hooper GD, Burton JR. Coronary bypass graft fate and patient outcome: angiographic follow-up of 5,065 grafts related to survival and reoperation in 1,388 patients during 25 years. J Am Coll Cardiol. 1996 Sep;28(3):616-26. doi: 10.1016/0735-1097(96)00206-9.

  PMID: 8772748 BACKGROUND

• Goldman S, Copeland J, Moritz T, Henderson W, Zadina K, Ovitt T, Doherty J, Read R, Chesler E, Sako Y, et al. Saphenous vein graft patency 1 year after coronary artery bypass surgery and effects of antiplatelet therapy. Results of a Veterans Administration Cooperative Study. Circulation. 1989 Nov;80(5):1190-7. doi: 10.1161/01.cir.80.5.1190.

  PMID: 2680158 BACKGROUND

• Mehta RH, Ferguson TB, Lopes RD, Hafley GE, Mack MJ, Kouchoukos NT, Gibson CM, Harrington RA, Califf RM, Peterson ED, Alexander JH; Project of Ex-vivo Vein Graft Engineering via Transfection (PREVENT) IV Investigators. Saphenous vein grafts with multiple versus single distal targets in patients undergoing coronary artery bypass surgery: one-year graft failure and five-year outcomes from the Project of Ex-Vivo Vein Graft Engineering via Transfection (PREVENT) IV trial. Circulation. 2011 Jul 19;124(3):280-8. doi: 10.1161/CIRCULATIONAHA.110.991299. Epub 2011 Jun 27.

  PMID: 21709060 BACKGROUND

• Hattler B, Messenger JC, Shroyer AL, Collins JF, Haugen SJ, Garcia JA, Baltz JH, Cleveland JC Jr, Novitzky D, Grover FL; Veterans Affairs Randomized On/Off Bypass (ROOBY) Study Group. Off-Pump coronary artery bypass surgery is associated with worse arterial and saphenous vein graft patency and less effective revascularization: Results from the Veterans Affairs Randomized On/Off Bypass (ROOBY) trial. Circulation. 2012 Jun 12;125(23):2827-35. doi: 10.1161/CIRCULATIONAHA.111.069260. Epub 2012 May 16.

  PMID: 22592900 BACKGROUND

• Raza S, Blackstone EH, Houghtaling PL, Rajeswaran J, Riaz H, Bakaeen FG, Lincoff AM, Sabik JF 3rd. Influence of Diabetes on Long-Term Coronary Artery Bypass Graft Patency. J Am Coll Cardiol. 2017 Aug 1;70(5):515-524. doi: 10.1016/j.jacc.2017.05.061.

  PMID: 28750693 BACKGROUND

• Sabik JF 3rd, Lytle BW, Blackstone EH, Houghtaling PL, Cosgrove DM. Comparison of saphenous vein and internal thoracic artery graft patency by coronary system. Ann Thorac Surg. 2005 Feb;79(2):544-51; discussion 544-51. doi: 10.1016/j.athoracsur.2004.07.047.

  PMID: 15680832 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Ziad A. Ali, MD,DPhil

  Saint Francis Hospital

  PRINCIPAL INVESTIGATOR

• Edward F. Lundy, MD, PhD

  Saint Francis Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ziad A. Ali, MD,DPhil

CONTACT

516-622-4552; ziadali.mail@gmail.com

Elizabeth S. Haag, RN

CONTACT

516-622-4552; Elizabeth.Haag@chsli.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: For follow-up visits, in person and via phone, the provider will be blinded. Physicians analyzing Coronary CT Angiograms (CCTA) will be blinded to the randomization arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of DeMatteis Cardiovascular Institute

Model Details: OCT-guided saphenous vein CABG

Study Record Dates

• First Submitted: November 15, 2021
• First Posted: November 22, 2021
• Study Start: April 4, 2022
• Primary Completion: April 4, 2024
• Study Completion: April 4, 2026
• Last Updated: May 5, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)