Study to Evaluate the Safety and Efficacy of Humacyte's Coronary Tissue Engineered Vessel (CTEV) in Patients With Coronary Artery Disease Requiring Coronary Artery Bypass Grafting (CABG)

Официальное название

A Phase 2a Study for the Evaluation of Safety and Efficacy of Humacyte's Coronary Tissue Engineered Vessel (CTEV) as a Vascular Conduit for Coronary Artery Bypass Grafting in Patients With Coronary Artery Disease

Обзор

The goal of this study is to assess safety and efficacy of Humacyte's coronary tissue engineered vessel (CTEV) used as a bypass conduit in patients requiring multi vessel coronary artery bypass grafting (CABG). The main question it aims to answer whether the CTEV is feasible as a conduit in CABG surgery. Each participant will be implanted with a CTEV using standard surgical techniques and followed for up to 36 months for routine assessments, including imaging, physical and clinical examinations, vital signs, laboratory assessments, and safety assessments.

Подробное описание

Prospective, non-randomized, open-label clinical study to assess the safety and efficacy of coronary tissue engineered vessel (CTEV) for secondary coronary targets in patients needing multiple coronary artery bypass.

Each eligible patient will have the left anterior descending (LAD) CA bypassed using the left internal mammary artery (LIMA). A single CTEV (single proximal and distal anastomoses) will be used to bypass either second or third coronary arteries (CA) bypass target. A native vessel shall be used for any additional targets as needed.

Patients will be followed at routine visits for up to 3 years post-implant.

Вмешательства

• Биопрепарат Humacyte Coronary Tissue Engineered Vessel (CTEV)
  The CTEV is a tissue-engineered acellular vascular conduit regulated as a biological product by the Food and Drug Administration (FDA). The CTEV has an inner diameter of 3.5 mm and with approximately 20 cm of usable length.

Первичные конечные точки

• Rate of events (MACE, AE, AESI, etc.) in all participants implanted with CTEV [Срок оценки: 36 months]

Вторичные конечные точки (5)

• Graft patency at month 2 assessment among all implanted grafts [Срок оценки: 2 Months]
• Graft patency at month 6 assessments among all implanted grafts [Срок оценки: 6 months]
• Graft patency at month 12 assessments among all implanted grafts [Срок оценки: 12 Months]
• Graft patency at month 24 assessments among all implanted grafts [Срок оценки: 24 Months]
• Graft patency at month 36 assessments among all implanted grafts [Срок оценки: 36 Months]

Критерии участия

Критерии включения

• Age ≥18 years with the ability to provide written informed consent.
• Planned first isolated CABG surgery for atherosclerotic coronary artery disease with a planned LIMA graft to the LAD and at least one other planned vessel bypass.
• An RCA or LCx territory target vessel for the CTEV graft with the following characteristics:

• Target vessel stenosis of ≥80% (including total occlusion) or a fraction flow reserve (FFR) of ≤0.8.
• Good target vessel quality with a diameter of at least 2.5 mm.
• Good target vessel run-off as determined by the Investigator.

Критерии исключения

• Recent (within 7 days) acute myocardial infarction.
• Hemodynamic instability or need for emergent CABG surgery.
• Acute heart failure or abnormal left ventricular wall motion (e.g., ejection fraction <55%).
• Ascending aortic pathology, including aneurysm, dissection, or significant calcification.
• Prior cardiac surgery.
• Planned concomitant valve or aortic surgery.
• Known bleeding disorder or thrombophilia.

• Thrombocytopenia (platelet count <100 x 109/L)
• Clinically significant anemia (hemoglobin <9.0 g/dL)
• Elevated prothrombin time (INR > 1.3) or partial thromboplastin time (>35 seconds) not due to anticoagulation therapy.
• Required post-operative anticoagulation therapy.
• Known or suspected allergies or contraindications to aspirin or clopidogrel, heparin, or contrast agents that cannot be adequately pre-treated.
• Chronic kidney disease with eGFR < 45 ml/min/1.73 m2).
• Previous exposure to the Humacyte ATEV (Symvess).
• Use of any investigational drug or device within 60 days.
• Women of childbearing potential defined as not sterile or not at least 1 year postmenopausal.
• Any condition, including active substance abuse, that in the opinion of the investigator, prevents participants from following the protocol, including the planned CT angiographic follow-up through at least 12-14 months.
• Active infection requiring ongoing antibiotic therapy or conditions that would increase the risk of infection or other complications evidenced by the following:

• Compromised immune function from medication or underlying disease
• Clinically significant low white blood cell count (leukopenia)
• Uncontrolled diabetes mellitus (HbgA1c >8.0%, serum glucose >300 mg/dL)
• Active malignancy.
• Clinically significant hepatic cirrhosis or dysfunction evident by any of the following laboratory abnormalities:

• AST or ALT ≥3x ULN
• low serum albumin < 2.0 g/dL
• high bilirubin > 2 mg/dL)
• Participants who are considered not suitable for on-pump CABG procedure.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07730528 · CLN-PRO-V021

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗