Health TrialsbyHealthPanel

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

ConditionAAA - Abdominal Aortic Aneurysm
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedtronic Cardiovascular

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18 years or older;

Male or non-pregnant female patients; women of childbearing potential must undergo a pregnancy test prior to enrollment, and the result must be negative;

Willing and able to provide written informed consent;

Maximum diameter of the abdominal aortic aneurysm (AAA) ≥ 4.5 cm in females or ≥ 5 cm in males;

Disqualifiers

Myocardial infarction within the past 3 months;

Systemic infection;

Ruptured or leaking AAA;

Infected or inflammatory AAA;

Trial design

Design model

Single group

Treatments tested in this trial

  • Heli-FX EndoAnchor System

    Device

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

Treatment groups

142 Participants
are divided into 1 treatment group
Group A: Heli-FXExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Primary Effectiveness Endpoint

Composite treatment endpoint of Heli-FX within 12 months: * Technical success * No Type Ia endoleak * No endograft migration of proximal stent graft component * No aortic aneurysm rupture

Time frame
From procedure to 12 months after index procedure
2

Primary Safety Endpoint

Percentage of patients experiencing one or more major adverse events (MAE) within 30 days post-operation. MAEs are defined as any of the following: * All-cause mortality (ACM) * Heli-FX device-related serious adverse event (SAE) * Myocardial infarction (MI) * Stroke (excluding transient ischemic attacks) * Renal failure (excluding renal insufficiency) * Respiratory failure

Time frame
within 30 days post-operation

Secondary outcomes

1

Secondary Endpoints

* Technical success and clinical success at the time of index procedure * All-cause mortality and aneurysm-related mortality at the time of index procedure, 30 days, 6 months, one year, and annually through 3 years. * Type Ia endoleak at 30 days, 6 months, one year, and annually through 3 years * Endograft migration at 6 months, one year, and annually through 3 years * Aneurysm sac change by diameter at 6 months, one year and annually through 3 years compared to the CT(Computed Tomography) imaging at 30 days after index procedure * Loss of endograft fabric integrity as a result of the EndoAnchor implant, rupture of the treated aneurys, conversion to open surgical repair at the time of index procedure, 30 days, 6 months, one year, and annually through 3 years * Myocardial infarction, stroke (excluding transient ischemic attacks), renal failure and respiratory failure at 30 days, 6 months, one year, and annually through 3 years

Time frame
From index-procedure to 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medtronic Cardiovascular

Lead sponsor

Source ClinicalTrials.gov
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