Clinical trial NCT04503395: ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES
Official title: Physician Initiated Trial Investigating ESAR (EVAR Plus Heli-FX EndoAnchors) and FEVAR for the Treatment of Aortic Aneurysms With Short Infrarenal Aortic Neck
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aortic Aneurysm, Abdominal
Lead sponsor: FCRE (Foundation for Cardiovascular Research and Education)
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2020-08-07
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: comparision of two different procedure to repair abdominal aortic aneurysms with short necks
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Effectiveness Endpoint - Technical Success
timeFrame: through 12 months post-procedure
measure: Safety Endpoint - Freedom from Major Adverse Events
timeFrame: through 30 days post-procedure
Secondary outcomes:
measure: Total contrast volume (ml) at index procedure
timeFrame: at index procedure
measure: Total fluoroscopy time (minutes) at index procedure
timeFrame: at index procedure
measure: Duration (minutes) of index procedure
timeFrame: at index procedure
measure: Adequate penetration of EndoAnchor implants as assessed by the Core Lab
timeFrame: at index procedure
measure: Clinical success
timeFrame: through 30 days post-procedure
measure: Visceral artery patency or occlusion at 1, 12, 24 and 36 months follow-up
timeFrame: through 1,12,24 and 36-months post-op
measure: Freedom from type Ia and III endoleaks at 1, 12, 24 and 36 months follow-up
timeFrame: through 1,12,24 and 36-months post-op
measure: Freedom from aneurysm related secondary reinterventions at 1, 12, 24 and 36 months follow-up
timeFrame: through 1,12,24 and 36-months post-op
measure: Freedom from aneurysm related mortality at 1, 12, 24 and 36 months follow-up
timeFrame: through 1,12,24 and 36-months post-op
measure: Freedom from stent graft migration (>10mm change from 1-month follow-up imaging) at 12, 24 and 36 months follow-up
timeFrame: through 12,24 and 36-months post-op
measure: Sac dynamics (>5mm change from 1-month follow-up imaging): increase, stable, decrease at 12, 24, and 36 months follow-up
timeFrame: through 12,24 and 36-months post-op
measure: Freedom from conversion to open repair at 1, 12, 24 and 36 months follow-up
timeFrame: through 1,12,24 and 36-months post-op
measure: Freedom from AAA rupture at 1, 12, 24 and 36 months follow-up
timeFrame: through 1,12,24 and 36-months post-op
measure: Overall SCI rate, include transient events at 1 and 12 months follow-up
timeFrame: through 1 and 12 months post-op
measure: Freedom from aortic neck-related secondary interventions
timeFrame: at 1-, 12-, 24- and 36-months follow-up
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UCSD Medical Center Hillcrest
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Grand Rapids
country: United States
facility: Corewell Health (Spectrum)
state: Michigan
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Charlotte
country: United States
facility: Atrium Health Carolinas Medical Center
state: North Carolina
city: Tulsa
country: United States
facility: Oklahoma Heart
state: Oklahoma
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Vienna
country: Austria
facility: Hospital Ottakring, Institute for Vascular Surgery
city: Genk
country: Belgium
facility: CRC thoracic Vascular Surgery, ZOL Genk
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent, Thoracale en vasculaire heelkunde
city: Boulogne
country: France
facility: Amrois Paré Hospital (APHP)
city: Clermont Ferrand
country: France
facility: Service de Chirurgie Vasculaire et Endovasculaire CHU Gabriel-Montpied 58 rue Montalembert
city: Lyon
country: France
facility: Hospices Civils de lyon - Hôpital Edouard Herriot
city: Rennes
country: France
facility: Centre Hospitalier Universitaire de Rennes
city: Aachen
country: Germany
facility: University Hospital RWTH Aachen
city: Leipzig
country: Germany
facility: University Hospital Leipzig
city: Münster
country: Germany
facility: Martin Austermann
city: Bologna
country: Italy
facility: University of Bologna, IRCCS S. Orsola Hospital,
city: Genova
country: Italy
facility: Az. Ospedaliera San Martino, Genova
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele, Chirurgia Vascolare
city: Perugia
country: Italy
facility: Vascular Endovascular Surgery University of Perugia;
city: Turin
country: Italy
facility: Az.Osped.Univers.S.Giovanni, Turin
city: Amsterdam
country: Netherlands
facility: VUMC Amsterdam
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Warszawa
country: Poland
facility: National Institute of Cardiology Warzwa
city: Madrid
country: Spain
facility: Hospital Ramon Y Cajal
city: San Sebastián
country: Spain
facility: Hospital Universitario Donostia
city: Valladolid
country: Spain
facility: HOSPITAL CLINICO UNIVERSITARIO Valladolid
city: Bern
country: Switzerland
facility: Inselspital Bern, Universitätsklinik für Gefässchirurgie
Study officials:
affiliation: Vascupedia
name: Giovanni Torsello, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical Director, Vascular Surgery Providence Heart and Vascular Institute
name: Brant Ullery, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References: