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

NCT ID: NCT05133492

Last Updated: 2025-12-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-24
• Study Completion Date: 2026-12-31

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.

Detailed Description

This is a Phase I multi-center, open-label study to evaluate use of the Nectero EAST system for stabilization of abdominal aortic aneurysms. Up to fifty (50) subjects will be treated at up to 10 worldwide sites with the device and followed for up to 36-months.

Primary Study Endpoints:

• Safety: absence of major events within the 1-month follow-up visit
• Success: defined as successful insertion of the delivery catheter and delivery of the Stabilizer

Secondary Study Endpoints:

• Freedom from aneurysmal sac enlargement. Enlargement is defined as diameter increase of >5mm per year, or aneurysm sac volume increase of >10% per year, as assessed by CT scans at the 1, 3, (HK only), 6, 12, 24 and 36-month follow-up visits.
• Aneurysm sac shrinkage, defined as diameter decrease of >5mm, or decrease in aneurysm sac volume of >10% as assessed by CT scans at the 1, 3 (HK only), 6, 12, 24 and 36-month follow-up visits.
• Assessment of Clinical Utility

Study duration is anticipated to be 6 years.

Conditions

Abdominal Aortic Aneurysm; AAA; Dilation Aorta

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Interventional

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.

Group Type: EXPERIMENTAL

Endovascular Aneurysm Stabilization Treatment (EAST)

Intervention Type: 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.

Interventions

Endovascular Aneurysm Stabilization Treatment (EAST)

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• Subject has active systemic infection.
• Subject is participating in another research study.
• Subject has other medical, social, or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment and the procedures and evaluations pre- and post-treatment.
• Women of childbearing potential who are pregnant, lactating, or planning to become pregnant during the course of the trial.
• Subject has dialysis dependent renal failure or baseline serum creatinine level >2.0mg/dl.
• Subjects with liver dysfunction: alanine transaminase (ALT) or aspartate transaminase (AST) is five times higher than the normal upper limit; serum total bilirubin (STB) is two times higher than the normal upper limit.
• Subjects who are not suitable for endovascular treatment, as judged by the investigator.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nectero Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen Cheng, MD

Role: PRINCIPAL_INVESTIGATOR

Queen Mary Hospital, Hong Kong

Locations

Prince of Wales Private Hospital

Randwick, New South Wales, Australia

Queen Mary Hospital

Hong Kong, Southern District, China

Pablo Tabon Uribe Hospital

Medellín, Antioquia, Colombia

Pauls Stradins Clinical University Hospital

Riga, , Latvia

Auckland City Hospital

Auckland, , New Zealand

Countries

Australia; China; Colombia; Latvia; New Zealand

References

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.

Reference Type: BACKGROUND

PMID: 37330148 (View on PubMed)

Related Links

https://pubmed.ncbi.nlm.nih.gov/37330148/

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

Other Identifiers

CTP001

Identifier Type: -

Identifier Source: org_study_id