First In Human Study for Small to Medium-sized Abdominal Aortic Aneurysm (AAA)

NCT05133492 | Active Not Recruiting

• 1 other identifier: CTP001
• Study Type: interventional
• Target: 46
• Locations: 5 countries
• Sites: 5

Brief Summary

This is a first in human study to evaluate the safety and clinical utility of an investigational medical device called the Nectero EAST System to treat Abdominal Aortic Aneurysms or AAA.

Conditions

Abdominal Aortic Aneurysm; AAA; Dilation Aorta

Keywords

Abdominal Aorta; Aneurysm

Outcome Measures

Primary Outcomes (2)

• Safety: Procedure and Device-Related Adverse Events

  Absence of major events (procedure and device-related) within the 1-month follow-up visit

  Up to 30 days

• Efficacy: Successful delivery of the EAST System into the AAA sac

  Successful insertion of the delivery catheter and delivery of the Stabilizer Compound

  Up to 30 days

Secondary Outcomes (2)

• Efficacy: Evaluation of the AAA sac diameter over the 36 month follow up period.

  Through study completion, an average of 3 years

• Efficacy: Evaluation of the AAA sac shrinkage over the 36 month follow up period.

  Through study completion, an average of 3 years

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.

Device: Endovascular Aneurysm Stabilization Treatment (EAST)

Interventions

Endovascular Aneurysm Stabilization Treatment (EAST) DEVICE

Endovascular procedure: an ipsilateral ilio-femoral aortogram to confirm suitability for placement of a 14F sheath will be performed. A baseline contrast aortogram will be performed to assess vessel patency and target location of the EAST delivery catheter. Occluding and Stabilizer balloons are inflated in preparation for Stabilizer Compound delivery within the AAA sac. A post-Stabilizer angiogram will re-assess vessel patency and aorta stability. Delivery catheter is removed and discarded. The entire procedure is approximately one hour.

Interventional

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or Female aged 18 years or older
• Subject can understand the purpose of the trial, voluntarily participate in the trial and sign the informed consent and is willing to complete the follow-up according to the requirements of the protocol.
• Infrarenal non-aneurysmal neck ≥15mm in length
• Aortic neck diameters ≤ 29mm
• Infrarenal neck angulation ≤ 60°
• Abdominal aneurysm from 3.5 cm to 5.0 cm.
• Overall AAA treatment length (distal renal to distal inferior margin of the aneurysm) not to exceed 10 cm
• Patient iliac or femoral arteries access vessels' size and morphology allow endovascular access of 14F introducer sheaths and catheters.
• Subject has \> one-year life expectancy.
• Subject is American Society of Anesthesiology (ASA) grade 1 through 3, inclusive.
• Subject is able and willing to comply with 1, 3, 6, 12, 24 and 36-month follow-up.

You may not qualify if:

• Subject has an acutely ruptured or leaking or emergent aneurysm.
• Subject has a dissecting aneurysm.
• Subject has a mycotic or infected aneurysm.
• Subject has current vascular injury due to trauma.
• Subject's aneurysm is thoracic or suprarenal.
• Previous surgical or endovascular aneurysm repair for abdominal aortic aneurysm.
• Subject has thrombus, calcification, and/or plaque that may compromise delivery.
• Subject has had a myocardial infarction within six (6) months prior to enrollment.
• Subject has current angina or other active cardiac condition such as congestive heart failure, untreated or worsening atrial arrhythmia, ventricular arrhythmia, or valvular disease.
• 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 polyester or contrast material that cannot be pretreated.
• Subject is morbidly obese or has other clinical conditions that severely inhibit X-ray visualization of the aorta.
• Subject has connective tissue disease (e.g., Marfan syndrome, Eaton syndrome, or Bessel's disease).
• Known contraindication to undergoing angiography or anticoagulation.

Sponsors & Collaborators

• Nectero Medical, Inc.: lead

Study Sites (5)

Prince of Wales Private Hospital

Randwick, New South Wales, 2031, Australia

Location

Queen Mary Hospital

Hong Kong, Southern District, China

Location

Pablo Tabon Uribe Hospital

Medellín, Antioquia, Colombia

Location

Pauls Stradins Clinical University Hospital

Riga, Latvia

Location

Auckland City Hospital

Auckland, New Zealand

Location

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. 2023 Jun 15:S0741-5214(23)01313-7

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Aneurysm

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Stephen Cheng, MD

  Queen Mary Hospital, Hong Kong

  PRINCIPAL INVESTIGATOR

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 small to medium-sized (3.5-5.0cm) abdominal aortic aneurym.

Study Record Dates

• First Submitted: November 3, 2021
• First Posted: November 24, 2021
• Study Start: June 24, 2019
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1); AU (1); CO (1); CN (1); LA (1)