ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATESPhysician-Initiated Trial Investigating ESAR (EVAR plus Heli-FX EndoAnchors) and FEVAR for the treatment of aortic aneurysms with short infrarenal aortic neck

Phase 4

Recruiting

Conditions: I71.4
Abdominal aortic aneurysm, without mention of rupture

Registration Number: DRKS00024025

Lead Sponsor: Foundation for Cardiovascular Research and Education (FCRE)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 204

Inclusion Criteria

1. Patient is >18 years old
2. Patient 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
3. The subject is not a candidate for safe, effective and durable standard EVAR due to challenging anatomical criteria as confirmed by the Core lab screening.
4. The subject is able and willing to comply with the protocol and to adhere to the follow-up requirements.
5. The Subject has provided written informed consent

CT- Angiographic inclusion criteria
6. 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 (IFUs)
7. Proximal neck length of the aorta within 4-15mm and a minimum circumferential sealing zone of 8mm
8. Aortic neck diameter from 19 to 31mm
9. Infrarenal neck angulation =45°

Exclusion Criteria

1. The subject is participating in a concurrent study which may confound study results
2. Subject has a life expectancy <2 year
3. The subject is a female of childbearing potential in whom pregnancy cannot be excluded
4. Subject with eGFR <30 mL/min/m2 (KDOQI classification – exclude class IV and above) and or on dialysis
5. Subject with an MI or CVA within 3 months before index procedure
6. Subject with known Connective Tissue Disease
7. The subject has a known hypersensitivity or contraindication to anticoagulants, antiplatelets, or contrast media, which is not amenable to post-treatment
8. Subject who has undergone prior endovascular or open surgical treatment for abdominal aortic aneurysm
9. Subject requires emergent aneurysm treatment, for example, trauma or rupture
10. Subject has a known hypersensitivity or allergies to study device implant material
11. Subject has an aneurysm that is:
- Suprarenal, pararenal, or thoracoabdominal
- Mycotic
- Inflammatory
- Pseudoaneurysm
12. Subject is presenting with thrombus or calcification of the proximal aneurysm neck: circumferential >50%
13. Pre-op stenosis of the renal arteries > 50%
14. The subject has an active infection or history of COVID-19. History of COVID-19 is defined as the availability of positive COVID-19 tests with sequela or hospitalization for treatment of COVID-19.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Effectiveness endpoint:<br>Composite of technical success at index procedure, and freedom from type IA or type III endoleak, freedom from aneurysm related mortality (ARM), and freedom from secondary reinterventions through 12 months post index procedure.<br>2. Safety endpoint: Freedom from MAE through 30 days post index procedure. MAE defined as: All-Cause-Mortality, Bowel Ischemia, Myocardial Infraction, Procedural Blood Loss > 1000cc, Access related complications, permanent paraplegia and paraparesis at 30 days, disabling stroke, respiratory failure, or renal complications

Secondary Outcome Measures