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

NCT05133492 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2025-12-16

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Nectero Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Stephen Cheng, MD · Queen Mary Hospital, Hong Kong

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-24
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Australia
  • China
  • Colombia
  • Latvia
  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05133492 on ClinicalTrials.gov