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Nectero EAST System treatment for small-to-mid abdominal aortic aneurysms

Randomized Controlled Clinical Trial (RCT) of the Nectero EAST System for Small to Mid-Sized Abdominal Aortic Aneurysms (AAA) StaBiLization: Evaluation of Efficacy.

Phase2; Phase3 Interventional Nectero Medical, Inc. · NCT06001918

This will test a single, locally delivered endovascular treatment (Nectero EAST System) to try to stabilize small-to-mid abdominal aortic aneurysms in adults instead of routine surveillance.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Enrollment400 (estimated)
Ages21 Years to 85 Years
SexAll
SponsorNectero Medical, Inc. Industry-sponsored
Locations39 sites (Scottsdale, Arizona and 38 other locations)
Trial IDNCT06001918 on ClinicalTrials.gov

What this trial studies

This randomized Phase 2/3 study will enroll adults with infrarenal fusiform abdominal aortic aneurysms of specified small-to-mid sizes and compare a one-time, locally delivered endovascular therapy to standard surveillance. Eligible participants must have suitable aortic and access vessel anatomy for a 14F introducer and meet basic surgical risk and life-expectancy criteria. Subjects randomized to either arm will be followed closely with visits at 30 and 60 days, 6, 12, 18 and 24 months, and then annually for up to five years to monitor aneurysm size, safety, and clinical outcomes. The primary goal is to determine whether the Nectero EAST System can stabilize aneurysm size compared with routine monitoring.

Who should consider this trial

Good fit: Ideal candidates are adults 21–85 years old (non-childbearing females), with infrarenal fusiform AAAs 3.5–5.0 cm in men or 3.5–4.5 cm in women, suitable aortic neck and access vessel anatomy for endovascular delivery, ASA class 1–3, and a life expectancy over three years.

Not a fit: Patients with larger aneurysms that already meet criteria for repair, unsuitable vascular anatomy for endovascular access, limited life expectancy, or who cannot commit to long-term follow-up are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, the treatment could slow or stop aneurysm growth and reduce the chance of needing later surgical repair or emergency intervention.

How similar studies have performed: Local single-dose endovascular biologic/device therapies for small AAAs are a relatively novel approach with limited early-phase data showing feasibility but no definitive evidence yet of long-term stabilization.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Scottsdale, Arizona and 38 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Abdominal Aortic Aneurysm
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.