MedTrace Logo

Aneurysm Treatment Using the Heli-FX™ EndoAnchor™ System China Study(ATHENA)

NCT07754318 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2026-08-10

No results posted yet for this study

Summary

To evaluate the safety and effectiveness of the Heli-FX EndoAnchor system in AAA subjects who without augmented radial fixation and/or sealing due to an endoleak or migration are at high risk for aneurysm-related complications or who are at high risk of migration or endoleak complications post-procedure, and to support product registration of Heli-FX EndoAnchor system with the National Medical Product Administration (NMPA) in China.

Conditions

  • AAA - Abdominal Aortic Aneurysm

Interventions

DEVICE

Heli-FX EndoAnchor System

Subjects will be implanted with Heli-FX EndoAnchor System for AAA treatment

Sponsors & Collaborators

  • Medtronic Cardiovascular

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-31
Primary Completion
2028-08-31
Completion
2030-08-31
FDA Device
Yes

More Related Trials

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 NCT07754318 on ClinicalTrials.gov