Nectero EAST System Retreatment Study

NCT07505082 | Recruiting

• 1 other identifier: EAST-003
• Study Type: interventional
• Target: 10
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

AAA - Abdominal Aortic Aneurysm; Aorta Aneurysm; Dilation Aorta

Keywords

Abdominal Aorta; Aneurysm

Outcome Measures

Primary Outcomes (3)

• Efficacy: technical success

  Technical success as defined by successful insertion of the catheter and delivery of the Stabilizer Solution dose.

  Up to 30 days

• Safety: adverse events post-treatment

  Treatment-related adverse events up to 30 days after retreatment with the Nectero EAST System.

  Up to 30 days

• Efficacy: aneurysm growth over time

  Aneurysmal growth rate post-treatment over time as compared to the immediate pretreatment annual growth rate. The growth rate over time in aneurysm diameter will be based on CT core laboratory readings at 12- and 24-months post-treatment.

  At 12 and 24 months post-treatment

Study Arms (1)

Interventional

EXPERIMENTAL

Use of the EAST System for the stabilization treatment of AAA. The device is delivered endovascularly and placed in the AAA sac to deliver the Stabilizer Infusion Solution.

Combination Product: Nectero EAST System

Interventions

Nectero EAST System COMBINATION_PRODUCT

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.

Interventional

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Nectero Medical, Inc.: lead

Study Sites (2)

Prince of Wales Private Hospital- POW Vascular Institute

Randwick, New South Wales, 2031, Australia

RECRUITING

Auckland City Hospital

Auckland, 1023, New Zealand

RECRUITING

Related Publications (1)

• 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 BACKGROUND

Related Links

• J Vasc Surg. Pilot Study

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Aortic Aneurysm; Aneurysm

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Central Study Contacts

Charlene Knape

CONTACT

866-755-4744; cknape@necterotx.com

Tracy Roberts

CONTACT

303--396-4603; troberts@necterotx.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Population diagnosed with abdominal aortic aneurysm ≤5.3 cm in males and ≤4.8 cm in females that have had a previous treatment with the Nectero EAST System.

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: April 1, 2026
• Study Start: March 3, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: May 26, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); NZ (1)