Physician Initiated Trial Investigating ESAR (EVAR Plus Heli-FX EndoAnchors) and FEVAR for the Treatment of Aortic Aneurysms With Short Infrarenal Aortic Neck

FCRE (Foundation for Cardiovascular Research and Education)32 sites in 10 countries204 target enrollmentMay 21, 2021

ConditionsAortic Aneurysm, Abdominal

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Aortic Aneurysm, Abdominal
Sponsor: FCRE (Foundation for Cardiovascular Research and Education)
Enrollment: 204
Locations: 32
Primary Endpoint: Effectiveness Endpoint - Technical Success
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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).

Registry

clinicaltrials.gov

Start Date

May 21, 2021

End Date

June 1, 2028

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

FCRE (Foundation for Cardiovascular Research and Education)

Responsible Party

Principal Investigator

Marc Bosiers, MD

Principal Investigator

FCRE (Foundation for Cardiovascular Research and Education)

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

Outcomes

Primary Outcomes

Effectiveness Endpoint - Technical Success

Time Frame: through 12 months post-procedure

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.

Safety Endpoint - Freedom from Major Adverse Events

Time Frame: through 30 days post-procedure

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 Outcomes

Total contrast volume (ml) at index procedure(at index procedure)
Total fluoroscopy time (minutes) at index procedure(at index procedure)
Duration (minutes) of index procedure(at index procedure)
Adequate penetration of EndoAnchor implants as assessed by the Core Lab(at index procedure)
Clinical success(through 30 days post-procedure)
Visceral artery patency or occlusion at 1, 12, 24 and 36 months follow-up(through 1,12,24 and 36-months post-op)
Freedom from type Ia and III endoleaks at 1, 12, 24 and 36 months follow-up(through 1,12,24 and 36-months post-op)
Freedom from aneurysm related secondary reinterventions at 1, 12, 24 and 36 months follow-up(through 1,12,24 and 36-months post-op)
Freedom from aneurysm related mortality at 1, 12, 24 and 36 months follow-up(through 1,12,24 and 36-months post-op)
Freedom from stent graft migration (>10mm change from 1-month follow-up imaging) at 12, 24 and 36 months follow-up(through 12,24 and 36-months post-op)
Sac dynamics (>5mm change from 1-month follow-up imaging): increase, stable, decrease at 12, 24, and 36 months follow-up(through 12,24 and 36-months post-op)
Freedom from conversion to open repair at 1, 12, 24 and 36 months follow-up(through 1,12,24 and 36-months post-op)
Freedom from AAA rupture at 1, 12, 24 and 36 months follow-up(through 1,12,24 and 36-months post-op)
Overall SCI rate, include transient events at 1 and 12 months follow-up(through 1 and 12 months post-op)
Freedom from aortic neck-related secondary interventions(at 1-, 12-, 24- and 36-months follow-up)