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Nectero EAST 系统临床研究 (stAAAble)

2026年9月23日 更新者：Nectero Medical, Inc.

Nectero EAST 系统治疗中小型腹主动脉瘤 (AAA) 稳定的随机对照临床试验 (RCT)：疗效评估。

The purpose of this randomized clinical trial is to treat patients with small to mid-sized abdominal aortic aneurysms (AAA), maximum diameter of 3.5 cm to 5.0 cm, using a locally delivered, single-dose endovascular treatment. The main question the study aims to answer is to demonstrate efficacy of the product for stabilization of these small to mid-sized AAA.The study will compare the treatment group to the typical standard of care for these patients, surveillance. All subjects will be followed at designated intervals at 30/60 days, 6, 12, 18 and 24 months with continued follow-up annually for up to 5 years.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

400

阶段

  • 阶段2
  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 新西兰
      • Auckland、新西兰、1023
        • 招聘中
        • Auckland City Hospital
        • 接触：
        • 首席研究员：
          • Andrew Holden, A/Prof
  • 澳大利亚
    • New South Wales
      • Randwick、New South Wales、澳大利亚、2031
        • 招聘中
        • Prince of Wales Private Hospital- POW Vascular Institute
        • 首席研究员：
          • Ramon Varcoe
        • 接触：
  • 美国
    • Arizona
      • Scottsdale、Arizona、美国、85258
        • 招聘中
        • Honor Health Scottsdale Shea Medical Center
        • 首席研究员：
          • Hasan Aldailami, MD
        • 接触：
          • HonorHealth Cardiovascular Research
          • 电话号码：480-323-1046
    • Colorado
      • Aurora、Colorado、美国、80045
        • 主动，不招人
        • University of Colorado
    • District of Columbia
      • Washington D.C.、District of Columbia、美国、20010
        • 招聘中
        • Medstar Washington Hospital Center
        • 首席研究员：
          • Steven Abramowitz, MD
        • 接触：
        • 接触：
    • Florida
    • Georgia
      • Augusta、Georgia、美国、30912
        • 招聘中
        • Medical College of Georgia
        • 首席研究员：
          • William Jordan, MD
        • 接触：
        • 接触：
    • Illinois
      • Chicago、Illinois、美国、60637
        • 招聘中
        • University of Chicago
        • 接触：
        • 首席研究员：
          • Ross Milner, MD
      • Elk Grove、Illinois、美国、60007
        • 尚未招聘
        • Ascension Alexian Brothers
        • 首席研究员：
          • Jack Chamberlin, MD
    • Maine
      • Scarborough、Maine、美国、04074
    • Massachusetts
      • Boston、Massachusetts、美国、02114
        • 招聘中
        • Massachusetts General Hospital
        • 首席研究员：
          • Nikolaos Zacharias, MD
        • 接触：
      • Boston、Massachusetts、美国、02215
      • Worcester、Massachusetts、美国、01655
    • Michigan
      • Royal Oak、Michigan、美国、48073
    • Missouri
      • St Louis、Missouri、美国、63110
        • 招聘中
        • Washington University School of Medicine
        • 首席研究员：
          • Luis Sanchez, MD
        • 接触：
    • Nebraska
      • Omaha、Nebraska、美国、68198
        • 招聘中
        • University of Nebraska Medical Center
        • 首席研究员：
          • Jonathan Thompson, MD
        • 接触：
    • New Hampshire
      • Lebanon、New Hampshire、美国、03766
        • 招聘中
        • Dartmouth Hitchcock Medical Center
        • 首席研究员：
          • Rebecca Scully, MD
        • 接触：
    • New York
      • Rochester、New York、美国、14642
      • Stony Brook、New York、美国、11794
    • North Carolina
      • Durham、North Carolina、美国、27710
        • 招聘中
        • Duke University Medical Center
        • 首席研究员：
          • Chandler Long, MD
        • 接触：
    • Ohio
      • Cincinnati、Ohio、美国、45219
      • Cleveland、Ohio、美国、44106
        • 招聘中
        • University Hospitals Cleveland
        • 首席研究员：
          • Jae Cho, MD
        • 接触：
      • Cleveland、Ohio、美国、44195
        • 招聘中
        • Cleveland Clinic
        • 首席研究员：
          • Francis Caputo, MD
        • 接触：
      • Columbus、Ohio、美国、43210
        • 招聘中
        • The Ohio State University Wexner Medical Center
        • 接触：
        • 首席研究员：
          • Kristine Orion, MD
      • Columbus、Ohio、美国、43214
        • 招聘中
        • Ohio Health Riverside
        • 首席研究员：
          • Joseph Campbell, MD
        • 接触：
    • Oklahoma
      • Tulsa、Oklahoma、美国、74104
    • Oregon
      • Portland、Oregon、美国、97239
        • 招聘中
        • Portland VA Medical Center
        • 首席研究员：
          • Matthew Koopmann, MD
        • 接触：
    • Pennsylvania
      • Bethlehem、Pennsylvania、美国、18015
        • 招聘中
        • St. Luke's University Health Network
        • 首席研究员：
          • Sharvil Sheth, MD
        • 接触：
      • Philadelphia、Pennsylvania、美国、19104
      • Philadelphia、Pennsylvania、美国、19107
        • 招聘中
        • Jefferson Clinical Research Institute
        • 接触：
        • 首席研究员：
          • Michael Nooromid, MD
      • Pittsburgh、Pennsylvania、美国、15219
        • 招聘中
        • University of Pittsburgh Medical Center
        • 接触：
        • 首席研究员：
          • Raymond Eid, MD
    • South Carolina
    • South Dakota
      • Sioux Falls、South Dakota、美国、57108
        • 招聘中
        • North Central Heart - A Division of Avera Heart Hospital
        • 首席研究员：
          • Michael Bacharach, MD
        • 接触：
    • Tennessee
      • Nashville、Tennessee、美国、37232
      • Nashville、Tennessee、美国、37212
        • 尚未招聘
        • VA Tennessee Valley Healthcare System
        • 首席研究员：
          • John Curci, MD
        • 接触：
    • Texas
      • Houston、Texas、美国、77004
      • Plano、Texas、美国、75093
        • 招聘中
        • Baylor Scott & White Medical Center
        • 首席研究员：
          • William Shutze, MD
        • 接触：
    • Utah
      • Salt Lake City、Utah、美国、84132
        • 招聘中
        • University of Utah Hospital
        • 接触：
        • 首席研究员：
          • Cali Johnson, MD
    • Virginia
      • Fairfax、Virginia、美国、22031
        • 招聘中
        • Inova Fairfax Medical Campus Inova Health Systems
        • 接触：
        • 首席研究员：
          • Kendal Endicott, MD
      • Norfolk、Virginia、美国、23507
        • 招聘中
        • Sentara Health
        • 首席研究员：
          • David Dexter, MD
        • 接触：
    • Washington
      • Seattle、Washington、美国、98104
        • 招聘中
        • University of Washington at Harborview Medical Center
        • 接触：
        • 首席研究员：
          • Benjamin Starnes, MD
    • Wisconsin

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

21年 至 85年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Males and females ≥21 to ≤85 years of age. Females must be of non-childbearing potential (menopause or sterilization).
  2. 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.
  3. Infrarenal atherosclerotic fusiform abdominal aortic aneurysm from 3.5 cm to 5.0 cm (male) and 3.5 cm to 4.5 cm (female).
  4. Infrarenal aortic neck ≥ 15 mm in length and ≤ 29 mm in diameter.
  5. Overall AAA treatment length (distal renal to distal inferior margin of the aneurysm) not to exceed 130 mm.
  6. Iliac and femoral artery access, vessel size and morphology allow endovascular access of 14F (or larger) introducer sheaths and catheters.
  7. Subject meets American Society of Anesthesiology (ASA) grade 1 through 3 criteria, inclusive.
  8. Subject has > three-year life expectancy.
  9. Subject is able and willing to comply with all required follow-up clinic visits including CT scans (pre-randomization, 6, 12, 18, 24 months and annually up to 5 years) and blood draws.

Exclusion Criteria:

  1. Subject has an acutely ruptured, leaking, dissecting or emergent aneurysm.
  2. Subject has a symptomatic infrarenal abdominal aortic aneurysm.
  3. Subject has a mycotic or infected aneurysm.
  4. Subject has current vascular injury due to trauma.
  5. Subject's aneurysm is thoracic, suprarenal or juxtarenal.
  6. Previous surgical or endovascular aneurysm repair for abdominal aortic aneurysm.
  7. 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.
  8. 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.
  9. 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.
  10. 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.
  11. Subject has undergone other major surgery within the 30 days prior to enrollment.
  12. Subjects with any transient ischemic attack (TIA) or ischemic stroke within 3 months.
  13. Known allergy to contrast material that cannot be adequately premedicated, delivery system materials (i.e., nylon, polyurethane) and/or pentagalloylglucose (PGG).
  14. Subject is morbidly obese or has other clinical conditions that severely inhibit X-ray visualization of the aorta.
  15. Subject has connective tissue/collagen disorder (e.g., Marfan syndrome, vascular Ehlers-Danlos Syndrome, Loeys-Dietz Syndrome, Eaton Syndrome, Bessel-Hagen disease, etc.).
  16. Known contraindication to undergoing angiography or receiving systemic anticoagulation during the procedure.
  17. Subject has active systemic infection.
  18. Subject is participating in another research trial that could interfere with the results of the trial (e.g., drug trial).
  19. 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.
  20. Subject has dialysis dependent renal failure or baseline serum creatinine level >2.5mg/dL or eGFR < 45 mL/min/1.73m2.
  21. Subjects with aminotransferase (ALT and/or AST) which is ≥1.5x upper limit of normal (ULN) or TB that is our of normal range for the evaluating laboratory.
  22. 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.
  23. Subjects that may not be able to tolerate transient occlusion of the aorta should not be considered for this study.
  24. Subjects with saccular AAA.
  25. 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.
  26. Subjects who are not suitable for the Nectero EAST System treatment, as determined by the investigator.
  27. 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.
  28. 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.
  29. 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).
  30. 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.
  31. Subjects with known right-sided heart failure or pathologically dilated inferior vena cava or hepatic veins indicative of congestive hepatopathy.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：Treatment Arm

Participants assigned to the treatment arm 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. Following treatment, surveillance of their AAA will be conducted using CT scans at 6 months, 12 months, 18 months, 24 months, and annually for 5 years.

Intervention: Drug: Stabilizer
药品：Nectero EAST System

Treated subjects will undergo an endovascular procedure with the Nectero EAST system and receive the Stabilizer Infusion Solution (drug) within 30 days of the study eligibility by CT scan as a one-time local delivery of the drug.
无干预：Control Arm

Participants assigned to the control arm will undergo surveillance of their AAA using CT scans at 6 months, 12 months, 18 months, 24 months, and annually for 5 years.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Primary Endpoint
大体时间：24 months

The primary endpoint is the composite of all AAA-related death, rupture and repair (open-surgical, EVAR, or clinically indicated for repair as adjudicated by a committee of clinical experts blinded to the assigned arm).
24 months

次要结果测量

结果测量
措施说明
大体时间
Growth
大体时间：24 months

The growth over time in aneurysm diameter based on CT core laboratory readings.
24 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Nectero Medical, Inc.

调查人员

  • 首席研究员：Daniel Clair, MD、Vanderbilt University Medical Center
  • 首席研究员：Grace Wang, MD、University of Pennsylvania

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2023年10月25日

初级完成 (估计的)

2028年6月30日

研究完成 (估计的)

2032年12月31日

研究注册日期

首次提交

2023年8月7日

首先提交符合 QC 标准的

2023年8月14日

首次发布 (实际的)

2023年8月21日

研究记录更新

最后更新发布 (实际的)

2026年9月28日

上次提交的符合 QC 标准的更新

2026年9月23日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • EAST002

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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