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Optical Coherence Tomography of the Saphenous Vein Graft (OCTOCAB)

4 de mayo de 2022 actualizado por: Ziad Ali, MD, DPhil, St. Francis Hospital, New York

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

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).

Descripción general del estudio

Estado

Reclutamiento

Descripción detallada

Within the first year of coronary artery bypass grafting (CABG) surgery, the saphenous vein grafts have a failure rate of 10 to 25%. Visual inspection of the vein graft conduit is the current standard in determining the quality of the vein segment. However, there may be intraluminal abnormalities that are undetectable via a visual inspection. OCT examination, using the ILUMIEN OPTIS NEXT OCT Imaging system, of endoscopically harvested saphenous vein conduits will indicate such pathology and enable the surgeon to assess the quality of the harvested vein at the intravascular level.

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 study will follow two randomization arms: OCT-guided saphenous vein CABG (interventional arm) vs. visual inspection-guided saphenous vein CABG (standard of care arm). The analysis of subjects will be with respect to their analyzed group.

Following enrollment, participants will be followed for up to 10 years. The primary endpoint is per graft incidence of vein graft failure. The assessment of the vein graft will be conducted via coronary CT angiogram (CCTA) at 12 months. In the case where the participant has unplanned angiogram due to clinical reasons, prior to the 12 months, the condition of the graft will be determined via the angiogram. Unless all target grafts have reached the endpoint prior to the 12 month time point, a CCTA will be required.

To achieve the power level of 85% at the significance level of 0.025, 760 patients is the anticipated sample size. Analysis will be conducted at the graft level with a Linear Mixed model to account for any potential patient effects.

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

760

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Ziad A. Ali, MD,DPhil
  • Número de teléfono: 516-622-4552
  • Correo electrónico: ziadali.mail@gmail.com

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

    • New York
      • Roslyn, New York, Estados Unidos, 11576
        • Reclutamiento
        • St Francis Hospital
        • Contacto:
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  1. Subject must be at least 18 years of age.
  2. 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.
  3. Subject must have undergone coronary angiography identifying at least one lesion that is clinically appropriate and suitable for saphenous vein bypass grafting.
  4. Subject must provide written Informed Consent prior to any study related procedure.

Exclusion Criteria:

  1. STEMI ≤24 hours from the onset of ischemic symptoms
  2. Creatinine clearance ≤30 ml/min/1.73 m2 (as calculated by MDRD formula for estimated GFR) and not on dialysis.
  3. Hypotension, shock or need for mechanical support or intravenous vasopressors at the time that the patient would be undergoing the index procedure.
  4. CHF (Killip class >2 or NYHA class >3)
  5. 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.
  6. Unstable ventricular arrhythmias
  7. Concomitant multi-valve surgery or major aortic root surgery.
  8. Planned non-cardiac surgery within 24 months after the index procedure
  9. Prior CABG
  10. Any planned PCI within any target vessel(s) within 24 months.
  11. Subject has known hypersensitivity or contraindication to any of the study drugs (including aspirin, all P2Y12 inhibitors).
  12. Subject has received a heart transplant.
  13. 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.).
  14. Subject has previously received or is scheduled to receive radiotherapy to a coronary artery (vascular brachytherapy), or the chest/mediastinum.
  15. Subject has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3.
  16. Subject has a documented or suspected hepatic disorder as defined as cirrhosis or Child-Pugh ≥ Class B.
  17. Subject has a history of bleeding diathesis or coagulopathy.
  18. Subject has life expectancy <2 years for any non-cardiac cause.
  19. Pregnant or nursing subjects and those who plan pregnancy in the period up to 2 years following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.
  20. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.

Conduit exclusion criteria

1. Severe conduit tortuosity of venous conduit (e.g., with varicosities) such that it is unlikely that the OCT catheter can be delivered without vascular damage.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.
OCT examination of harvested saphenous vein conduits will indicate pathology. Under the surgeon's discretion the conduit segments with pathology will not be grafted.
Otros nombres:
  • 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
Sin intervención: Visual inspection-guided saphenous vein graft coronary artery graft surgery
Harvested saphenous vein conduits will be assessed visually and will undergo a blinded OCT.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Vein graft failure (VGF)
Periodo de tiempo: 12 months
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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Mortalidad por cualquier causa
Periodo de tiempo: 12 meses
12 meses
Target graft failure (TGF)
Periodo de tiempo: 12 months
Composite time-to-first event rate of cardiac death, target graft myocardial infarction (TG-MI), or ischemia-driven target graft revascularization (ID-TGR)
12 months
Per graft incidence of ischemic vein graft failure
Periodo de tiempo: 12 months
Greater than or equal to 70% stenosis
12 months
Per graft incidence anatomic vein graft failure
Periodo de tiempo: 12 months
Greater than or equal to 50% stenosis
12 months
Per patient incidence of vein graft patency
Periodo de tiempo: 12 months
Vein graft having less than 50% stenosis
12 months
Per patient incidence of ischemic vein graft failure
Periodo de tiempo: 12 months
Greater than or equal to 70% stenosis
12 months
Per patient incidence of anatomic vein graft failure
Periodo de tiempo: 12 months
Greater than or equal to 50% stenosis
12 months
Mean vein graft diameter stenosis
Periodo de tiempo: 12 months
12 months
Mean vein graft area stenosis
Periodo de tiempo: 12 months
12 months
Cardiac and non-cardiac mortality
Periodo de tiempo: 12 months
12 months
All Myocardial Infarction (MI)
Periodo de tiempo: 12 months
12 months
Target graft myocardial infarction (TG-MI) and Non-Target graft myocardial infarction (non-TG-MI)
Periodo de tiempo: 12 months
12 months
All revascularization
Periodo de tiempo: 12 months
12 months
Ischemia driven (ID)-revascularization and Non-ischemia driven (ID)-revascularization
Periodo de tiempo: 12 months
12 months
Ischemia driven-target graft failure (ID-TGR)
Periodo de tiempo: 12 months
12 months
Ischemia driven (ID)-revascularization of target native coronary artery subtended by the graft
Periodo de tiempo: 12 months
12 months

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Intimal injury
Periodo de tiempo: 12 months
Major - Disruption of intima with arc ≥ 60˚ AND length: ≥ 2 mm Minor - Disruption of intima with arc <60˚ AND length: <2 mm
12 months
Intraluminal mass
Periodo de tiempo: 12 months
Major - Mass extending ≥ 5 cm and ≥ 2 mm in diameter Minor - Mass extending < 5 cm and < 2 mm in diameter
12 months
Intramural hematoma
Periodo de tiempo: 12 months
Major - ≥ 60˚ arc and length ≥ 5mm Minor - < 60˚ arc and length < 5mm
12 months
Valvular sclerosis
Periodo de tiempo: 12 months
Major - > 0.25mm thickness Minor - ≤ 0.25mm thickness with redundant valve tissue
12 months
Immunohistochemistry
Periodo de tiempo: 12 months
Relationship between the OCT-identified abnormalities with immunohistochemistry in the surplus and OCT-guided excluded segments of vein grafts for histological validation of OCT-identified abnormal findings.
12 months
Transit-Time Flow Meter (TTFM)
Periodo de tiempo: 12 months
All grafts will be assessed with TTFM to assess anastomosis. Data will be reviewed to determine whether TTFM abnormalities correlated to OCT findings.
12 months
Relationship between OCT parameters and endpoint rates
Periodo de tiempo: 12 months
12 months
Relationship between OCT parameters at baseline in the standard of care arm with OCT findings in vivo during follow-up
Periodo de tiempo: 12 months
12 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Ziad A. Ali, MD,DPhil, Saint Francis Memorial Hospital
  • Investigador principal: Edward F. Lundy, MD, PhD, Saint Francis Memorial Hospital

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

4 de abril de 2022

Finalización primaria (Anticipado)

4 de abril de 2024

Finalización del estudio (Anticipado)

4 de abril de 2026

Fechas de registro del estudio

Enviado por primera vez

15 de noviembre de 2021

Primero enviado que cumplió con los criterios de control de calidad

15 de noviembre de 2021

Publicado por primera vez (Actual)

22 de noviembre de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

5 de mayo de 2022

Última actualización enviada que cumplió con los criterios de control de calidad

4 de mayo de 2022

Última verificación

1 de mayo de 2022

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

producto fabricado y exportado desde los EE. UU.

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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