Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:57 PM
Ignite Modification Date:
2025-12-24 @ 1:57 PM
NCT ID:
NCT04503395
Eligibility Criteria:
Inclusion Criteria:
* Subject is \>18 years old
* Subject is scheduled for primary treatment of the abdominal aortic aneurysm with a non-aneurysmal infrarenal aortic sealing zone proximal to the aneurysm that is sufficiently healthy for a proximal neck length that is at least 4mm and not more than15 mm and has a circumferential minimum sealing zone length of 8 mm
* Subject is not a candidate for safe, effective and durable standard EVAR due to challenging anatomical criteria as confirmed by the Core Lab screening
* Subject is able and willing to comply with the protocol and to adhere to the follow-up requirements.
* Subject has provided written informed consent
CT Angiographic Inclusion Criteria
* Subject meets the other anatomical requirements according to the locally applicable Endurant II/IIs stent graft system, Heli-FX EndoAnchor system, Terumo Fenestrated Anaconda (available in EU only) and/or Cook Zenith Fenestrated Graft Instructions for Use
* Proximal neck length of the aorta within 4-15mm and a minimum circumferential sealing zone of 8mm
* Aortic neck diameter from 19 to 31mm
* Infrarenal neck angulation ≤45°
Exclusion Criteria:
* Subject is participating in a concurrent study which may confound study results
* Subject has a life expectancy \<2 year
* Subject is female of childbearing potential in whom pregnancy cannot be excluded
* Subject with eGFR \<30 mL/min/m2 (KDOQI classification - exclude class IV and above) and or on dialysis
* Subject with a MI or CVA within 3 months prior to index procedure
* Subject with known Connective Tissue Disease
* Subject has a known hypersensitivity or contraindication to anticoagulants, antiplatelets, or contrast media, which is not amenable to post-treatment
* Subject who has undergone prior endovascular or open surgical treatment for abdominal aortic aneurysm
* Subject requires emergent aneurysm treatment, for example, trauma or rupture
* Subject has a known hypersensitivity or allergies to study device implant material
* Subject has an aneurysm that is:
* Suprarenal, pararenal, or thoracoabdominal
* Mycotic
* Inflammatory
* Pseudoaneurysm
* Subject is presenting with thrombus or calcification of the proximal aneurysm neck: circumferential \>50%
* Pre-op stenosis of the renal arteries \> 50%
* Subject has active infection or history of COVID-19. History of COVID-19 is defined as availability of positive COVID-19 test with sequelae or hospitalization for treatment of COVID-19.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04503395
Study Brief:
Protocol Section:
NCT04503395