Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Optical Coherence Tomography of the Saphenous Vein Graft (OCTOCAB)

4 mai 2022 mis à jour par: 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).

Aperçu de l'étude

Statut

Recrutement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Anticipé)

760

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

    • New York
      • Roslyn, New York, États-Unis, 11576
        • Recrutement
        • St Francis Hospital
        • Contact:
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Tripler

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Autres noms:
  • 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
Aucune intervention: Visual inspection-guided saphenous vein graft coronary artery graft surgery
Harvested saphenous vein conduits will be assessed visually and will undergo a blinded OCT.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Vein graft failure (VGF)
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Mortalité toutes causes confondues
Délai: 12 mois
12 mois
Target graft failure (TGF)
Délai: 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
Délai: 12 months
Greater than or equal to 70% stenosis
12 months
Per graft incidence anatomic vein graft failure
Délai: 12 months
Greater than or equal to 50% stenosis
12 months
Per patient incidence of vein graft patency
Délai: 12 months
Vein graft having less than 50% stenosis
12 months
Per patient incidence of ischemic vein graft failure
Délai: 12 months
Greater than or equal to 70% stenosis
12 months
Per patient incidence of anatomic vein graft failure
Délai: 12 months
Greater than or equal to 50% stenosis
12 months
Mean vein graft diameter stenosis
Délai: 12 months
12 months
Mean vein graft area stenosis
Délai: 12 months
12 months
Cardiac and non-cardiac mortality
Délai: 12 months
12 months
All Myocardial Infarction (MI)
Délai: 12 months
12 months
Target graft myocardial infarction (TG-MI) and Non-Target graft myocardial infarction (non-TG-MI)
Délai: 12 months
12 months
All revascularization
Délai: 12 months
12 months
Ischemia driven (ID)-revascularization and Non-ischemia driven (ID)-revascularization
Délai: 12 months
12 months
Ischemia driven-target graft failure (ID-TGR)
Délai: 12 months
12 months
Ischemia driven (ID)-revascularization of target native coronary artery subtended by the graft
Délai: 12 months
12 months

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Intimal injury
Délai: 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
Délai: 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
Délai: 12 months
Major - ≥ 60˚ arc and length ≥ 5mm Minor - < 60˚ arc and length < 5mm
12 months
Valvular sclerosis
Délai: 12 months
Major - > 0.25mm thickness Minor - ≤ 0.25mm thickness with redundant valve tissue
12 months
Immunohistochemistry
Délai: 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)
Délai: 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
Délai: 12 months
12 months
Relationship between OCT parameters at baseline in the standard of care arm with OCT findings in vivo during follow-up
Délai: 12 months
12 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

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

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

4 avril 2022

Achèvement primaire (Anticipé)

4 avril 2024

Achèvement de l'étude (Anticipé)

4 avril 2026

Dates d'inscription aux études

Première soumission

15 novembre 2021

Première soumission répondant aux critères de contrôle qualité

15 novembre 2021

Première publication (Réel)

22 novembre 2021

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

5 mai 2022

Dernière mise à jour soumise répondant aux critères de contrôle qualité

4 mai 2022

Dernière vérification

1 mai 2022

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Oui

produit fabriqué et exporté des États-Unis.

Oui

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner