Randomized controlled clinical trial on the application of Heli-FX EndoAnchors in conjunction with the Endurant II/IIs endograft in infrarenal aortic aneurysms with a wide infrarenal neck
- Conditions
- bulge in the aortaenlarged abdominal blood vessel1000318410002363
- Registration Number
- NL-OMON53733
- Lead Sponsor
- Rijnstate Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 28
• Age 18 years or older
• Provided written informed consent
• Clinical necessity for treatment of the AAA, according to the current
guidelines in the geographies participating
• Elective repair
• Eligible anatomy for treatment with the Endurant II/IIs endograft and Heli-FX
EndoAnchors according to the IFU of both devices
• Infrarenal neck diameter >= 28 mm and <=32 mm
• Proximal neck length >=10mm
• Anatomy outside the IFU of the Endurant II/IIs endograft and/or Heli-FX
EndoAnchors
• Planned use of AUI main body device
• Patient is participating in another clinical study, potentially conflicting
with the outcomes of the current study.
• Patient with eGFR < 30 ml/min/1.73m2 before the intervention
• Patient*s life expectancy <2 years as judged by the investigator
• Patient has a psychiatric or other condition that may interfere with the study
• Patient has a known allergy to any device component
• Patients with a systemic infection who may be at increased risk of
endovascular graft infection.
• Patient has a coagulopathy or uncontrolled bleeding disorder
• Patient has a ruptured, leaking, or mycotic aneurysm
• Patient is not eligible for standard EVAR
• Patient had a Cerebro Vascular Accident (CVA) or a myocardial infarction (MI)
within the prior three months
• Patient is pregnant (Female patients of childbearing potential only)
• Patient has active COVID-19 infection or has been diagnosed with long
COVID-19 requiring hospitalization within the 6 months prior to procedure.
• Patient has previously been treated with stent grafts in the aorto-iliac
arteries
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is a composite based on core lab reported data from<br /><br>computed tomography (CT) with contrast imaging of freedom from:<br /><br>(1) type IA endoleak AND<br /><br>(2) Migration of the proximal portion of the stent graft >=5 mm (compared to<br /><br>1-month imaging) AND<br /><br>(3) Aneurysm sac growth >=5 mm (compared to 1-month imaging).</p><br>
- Secondary Outcome Measures
Name Time Method <p>The following secondary endpoints will be evaluated using core lab reported<br /><br>data :<br /><br>• Freedom from type IA endoleak<br /><br>• Freedom from migration of the proximal portion of the stent graft >= 5 mm<br /><br>(compared to 1-month imaging)<br /><br>• Freedom from aneurysm growth >= 5 mm (compared to 1-month imaging)<br /><br>• Freedom from neck dilatation >=3 mm</p><br>