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StAAAble Trial

  • Status
    Accepting Candidates
  • Age
    21 Years - 85 Years
  • Sexes
  • Healthy Volunteers


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.


Full study title stAAAble Trial: Randomized Controlled Clinical Trial (RCT) of the Nectero EAST System for Small to Mid-Sized Abdominal Aortic Aneurysms (AAA) StaBiLization: Evaluation of Efficacy
Protocol number OCR44356 ID NCT06001918
Phase Phase 2/Phase 3


Inclusion Criteria:

  1. Males and females ≥21 * ≤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).

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 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.

  1. Subject has undergone other major surgery within the 30 days prior to enrollment.

  2. Subjects with any transient ischemic attack (TIA) or ischemic stroke within 3 months.

  3. Known allergy to contrast material, delivery system materials (i.e., nylon,

polyurethane) and/or Pentagalloyl Glucose (PGG).

  1. Subject is morbidly obese or has other clinical conditions that severely inhibit X-ray

visualization of the aorta.

  1. Subject has connective tissue/collagen disorder (e.g., Marfan syndrome, vascular

Ehlers-Danlos Syndrome, Loeys-Dietz Syndrome, Eaton Syndrome, Bessel-Hagen disease,


  1. Known contraindication to undergoing angiography or receiving systemic


  1. Subject has active systemic infection.

  2. Subject is participating in another research trial that could interfere with the

results of the trial (e.g., drug trial).

  1. 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.

  1. Subject has dialysis dependent renal failure or baseline serum creatinine level

>2.5mg/dL or eGFR < 45 mL/min/1.73m2.

  1. Subjects with liver dysfunction: alanine transaminase (ALT) or aspartate transaminase

(AST) which is 3 times higher than the normal upper limit; serum total bilirubin (STB)

that is 1.5 times higher than the normal upper limit or has clinical evidence of


  1. 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.

  1. Subjects that may not be able to tolerate transient occlusion of the aorta should not

be considered for this study.

  1. Subjects with saccular AAA.

  2. 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.

  1. Subjects who are not suitable for the Nectero EAST System treatment, as determined by

the investigator.

Lead researcher

Participate in a study

Here are some general steps to consider when participating in a research study:

  1. Step

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step


    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.