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

A Clinical Pilot Study to Evaluate the Safety and Clinical Utility of The Nectero EAST System for Stabilization of Abdominal Aortic Aneurysms

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Abdominal Aortic Aneurysm; AAA; Dilation Aorta
• Intervention / Treatment: Device: Endovascular Aneurysm Stabilization Treatment (EAST)

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.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Charlene Knape; Phone Number: (866) 755-4744; Email: cknape@necteromedical.com
• Study Contact Backup: Name: Kelvin Ning; Phone Number: (866) 755-4744; Email: kning@necteromedical.com

Study Locations

• Australia
  • New South Wales
    • Randwick, New South Wales, Australia, 2031
      • Prince of Wales Private Hospital
• China
  • Southern District
    • Hong Kong, Southern District, China
      • Queen Mary Hospital
• Colombia
  • Antioquia
    • Medellín, Antioquia, Colombia
      • Pablo Tabon Uribe Hospital
• New Zealand
  • Auckland, New Zealand
    • Auckland City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy: Evaluation of the AAA sac diameter over the 36 month follow up period.	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.	Through study completion, an average of 3 years
Efficacy: Evaluation of the AAA sac shrinkage over the 36 month follow up period.	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.	Through study completion, an average of 3 years

Collaborators and Investigators

• Sponsor: Nectero Medical, Inc.
• Investigators: Principal Investigator: Stephen Cheng, MD, Queen Mary Hospital, Hong Kong

Publications and helpful links

General Publications

• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2019
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: November 3, 2021
• First Submitted That Met QC Criteria: November 12, 2021
• First Posted (Actual): November 24, 2021

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 2, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Aneurysm; Abdominal Aorta
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: CTP001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No