iHub Stent-Graft for Iliac Artery Aneurysms: Safety, Performance, and Effectiveness Study
Recruiting
N/A
Interventional Study
Iliac Aneurysm
Aortic Aneurysm, Abdominal
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 10 (estimated)
- Sponsor
- Archo Medical S.A · Other
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About This Trial
The goal of this clinical trial is to evaluate the safety, performance, and Preliminary effectiveness of the iHub endoprosthesis system in treating iliac artery aneurysms in adult patients requiring endovascular repair. The study population includes both male and female adults over 18 years of age who meet the inclusion criteria for endovascular treatment of iliac artery aneurysms.
The main quest…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: Sign the Informed Consent Form (ICF); Are ≥ 18 years of age;
Meet at least one of the following criteria for iliac artery aneurysm:
1. Common iliac artery aneurysm ≥ 25 mm in diameter;
2. Aneurysm growth of 5 mm or more within the last six months;
3. Maximum aneurysm diameter e…
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