ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES

Foundation for Cardiovascular Research and Education (FCRE)

Status: Enrolling

Conditions: Aortic Aneurysm, Abdominal

Treatments: Device: FEVAR treatment : Fenestrated endograft; Device: ESAR treatment: Endograft + Heli-FX Endoanchor

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04503395

FCRE-191125

Details and patient eligibility

About

The aim of this randomized study is to compare the safety and performance of EndoVascular Aneurysm Repair with ESAR using Endurant + Heli-FX™ EndoAnchor™ system and FEVAR using customizable grafts from Cook (Zenith Fenestrated Graft) and Terumo (Fenestrated Anaconda Graft) for the treatment of aortic aneurysms with short aortic neck (4 to 15mm).

Enrollment: 204 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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204 participants in 2 patient groups

ESAR

Experimental group

Description:

Endovascular Aneurysm Repair + Heli-FX EndoAnchors

Treatment:

Device: ESAR treatment: Endograft + Heli-FX Endoanchor

FEVAR

Active Comparator group

Description:

Fenestrated EndoVascular Aneurysm Repair

Treatment:

Device: FEVAR treatment : Fenestrated endograft