Nectero EAST System Retreatment Study

Официальное название

A Clinical Pilot Study to Evaluate the Safety and Clinical Utility of Retreatment With the Nectero EAST System for Stabilization of Abdominal Aortic Aneurysms

Обзор

This is an exploratory pilot study to evaluate the safety and clinical utility of retreatment with an investigational combination product called the Nectero EAST System to treat Abdominal Aortic Aneurysms or AAA.

Вмешательства

• Комбинированный продукт Nectero EAST System
  Participants will undergo an endovascular procedure using the Nectero EAST System to deliver the Stabilizer Infusion Solution directly inside the aneurysm. This is a one-time local delivery of the product.

Первичные конечные точки

• Efficacy: technical success [Срок оценки: Up to 30 days]
• Safety: adverse events post-treatment [Срок оценки: Up to 30 days]
• Efficacy: aneurysm growth over time [Срок оценки: At 12 and 24 months post-treatment]

Критерии участия

Критерии включения

• Received initial Nectero EAST System treatment under protocol CTP-001.
• Males and females ≥21 to ≤85 years of age. Females must be of non-childbearing potential (menopause or sterilization).
• Subject understands the purpose of the trial, agrees to voluntarily participate in the trial, signs the informed consent and is willing to complete the follow-up according to the requirements of the protocol.
• Infrarenal atherosclerotic fusiform abdominal aortic aneurysm ≤5.3 cm (male) and ≤4.8 cm (female).
• Infrarenal aortic neck ≥ 15 mm in length and ≤ 29 mm in diameter.
• Overall AAA treatment length (distal renal artery to distal inferior margin of the aneurysm) not to exceed 130 mm.
• Iliac and femoral artery access, vessel size and morphology allow endovascular access of 14F (or larger) introducer sheaths and catheters.
• Subject meets American Society of Anesthesiology (ASA) grade 1 through 3 criteria, inclusive.
• Subject has > two-year life expectancy.
• Subject is able and willing to comply with all required follow-up clinic visits including CT scans (screening, 6, 12, 24 months) and blood draws.

Критерии исключения

• Subject has an acutely ruptured, leaking, dissecting or emergent aneurysm.
• Subject has a symptomatic infrarenal abdominal aortic aneurysm.
• Subject has a mycotic or infected aneurysm.
• Subject has current vascular injury due to trauma.
• Subject's aneurysm is thoracic, suprarenal or juxtarenal.
• Previous surgical or endovascular aneurysm repair for abdominal aortic aneurysm.
• Subject has anatomy of diffuse, ulcerated, or extensive (shaggy) thrombus in the neck of the AAA, that in the opinion of the vascular surgeon/investigator, could result in embolization of the thrombus.
• Subject has anatomy of calcification, and/or plaque within the ilio-femoral arteries or severe infrarenal neck angulation that may compromise or does not allow delivery of the Introducer Sheath or the delivery catheter of the Nectero EAST System.
• Subject has had a myocardial infarction within six (6) months prior to enrollment or elevated CK enzymes or troponin indicative of an evolving MI prior to procedure.
• Subject has current angina, unstable angina, or other active cardiac condition such as congestive heart failure III and IV, atrial arrhythmia, ventricular arrhythmia, or valvular disease, requiring intervention.
• Subject has undergone other major surgery within the 30 days prior to enrollment.
• Subjects with any transient ischemic attack (TIA) or ischemic stroke within 3 months.
• Known allergy to contrast material that cannot be adequately premedicated, delivery system materials (i.e., nylon, polyurethane) and/or pentagalloylglucose (PGG).
• Subject is morbidly obese or has other clinical conditions that severely inhibit X-ray visualization of the aorta.
• Subject has connective tissue/collagen disorder (e.g., Marfan syndrome, vascular Ehlers-Danlos Syndrome, Loeys-Dietz Syndrome, Eaton Syndrome, Bessel-Hagen disease, etc.).
• Known contraindication to undergoing angiography or receiving systemic anticoagulation during the procedure.
• Subject has active systemic infection.
• Subject is participating in another research trial that could interfere with the results of the trial (e.g., drug trial).
• Subject has other medical, social, or psychological problems that, in the opinion of the investigator, preclude them from participation in the trial and to undergo the procedures and evaluations pre- and post-treatment.
• Subject has dialysis dependent renal failure or baseline serum creatinine level >2.5mg/dL or eGFR < 45 mL/min/1.73m2.
• Subjects with aminotransferase (ALT and/or AST) which is ≥1.5x upper limit of normal (ULN) or TB is out of normal range for the evaluating laboratory.
• Subjects that may not tolerate the lowering of their systolic blood pressure to approximately 100mmHg, should not be considered for this study or treated using the Nectero EAST System.
• Subjects that may not be able to tolerate transient occlusion of the aorta should not be considered for this study.
• Subjects with saccular AAA.
• Subjects with rapidly expanding AAA (previous diameter increases of ≥0.5 cm in 6-months or ≥1 cm in 1 year) as these should be evaluated for immediate repair.
• Subjects who are not suitable for the Nectero EAST System treatment, as determined by the investigator.
• Subjects with INR out of normal range for the evaluating laboratory for a subject not on anti-coagulant therapy; or INR >3 for a subject on anti-coagulant therapy.
• Subjects with active/acute or a history of unstable chronic liver disease or current liver disease including but not limited to liver transplant, known genetic disorders such as Gilbert syndrome or other liver diseases.
• Subjects with cirrhosis (e.g., known history or new clinical diagnosis by elastography with a fibrosis score of F3 or F4 and/or steatosis grade of S3).
• Subjects with uncontrolled alcohol use disorder or current alcohol use putting them at risk of liver disease: including consumption of above one standard drink per day for women and two standard drinks per day for men.
• Subjects with known right-sided heart failure or pathologically dilated inferior vena cava or hepatic veins indicative of congestive hepatopathy.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Австралия · 1 центр

• Prince of Wales Private Hospital- POW Vascular Institute — Randwick

Новая Зеландия · 1 центр

• Auckland City Hospital — Auckland

Публикации

• Cheng SWK, Eagleton M, Echeverri S, Munoz JG, Holden AH, Hill AA, Krievins D, Ramaiah V. A pilot study to evaluate a novel localized treatment to stabilize small- to medium-sized infrarenal abdominal aortic aneurysms. J Vasc Surg. 2023 Oct;78(4):929-935.e1. doi: 10.1016/j.jvs.2023.05.056. Epub 2023 Jun 15. PMID 37330148

Идентификаторы

NCT: NCT07505082 · EAST-003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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