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

Overview

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).

Interventions

• Device ESAR treatment: Endograft + Heli-FX Endoanchor
  ESAR treatment: Endurant II or Endurant IIs endograft + Heli-FX Endoanchor
• Device FEVAR treatment : Fenestrated endograft
  Cook Zenith Fenestrated Graft or the Terumo Fenestrated Anaconda Graft

Primary outcome measures

• Effectiveness Endpoint - Technical Success [Time frame: through 12 months post-procedure]
• Safety Endpoint - Freedom from Major Adverse Events [Time frame: through 30 days post-procedure]

Secondary outcome measures (12)

• Total contrast volume (ml) at index procedure [Time frame: at index procedure]
• Total fluoroscopy time (minutes) at index procedure [Time frame: at index procedure]
• Duration (minutes) of index procedure [Time frame: at index procedure]
• Adequate penetration of EndoAnchor implants as assessed by the Core Lab [Time frame: at index procedure]
• Clinical success [Time frame: through 30 days post-procedure]
• Visceral artery patency or occlusion at 1, 12, 24 and 36 months follow-up [Time frame: 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 [Time frame: through 1,12,24 and 36-months post-op]
• Freedom from aneurysm related secondary reinterventions at 1, 12, 24 and 36 months follow-up [Time frame: through 1,12,24 and 36-months post-op]
• Freedom from aneurysm related mortality at 1, 12, 24 and 36 months follow-up [Time frame: 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 [Time frame: 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 [Time frame: through 12,24 and 36-months post-op]
• Freedom from conversion to open repair at 1, 12, 24 and 36 months follow-up [Time frame: through 1,12,24 and 36-months post-op]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 9 centers

• UCSD Medical Center Hillcrest — La Jolla
• Stanford University — Stanford
• University of Florida — Gainesville
• Corewell Health (Spectrum) — Grand Rapids
• Mount Sinai Hospital — New York
• Oklahoma Heart — Tulsa
• Providence Portland Medical Center — Portland
• Allegheny General Hospital — Pittsburgh
• … and 1 more center

Italy · 6 centers

• University of Bologna, IRCCS S. Orsola Hospital, — Bologna
• Az. Ospedaliera San Martino, Genova — Genova
• IRCCS Ospedale San Raffaele, Chirurgia Vascolare — Milan
• Vascular Endovascular Surgery University of Perugia; — Perugia
• Az.Osped.Univers.S.Giovanni, Turin — Turin
• Azienda Ospedaliera Universitaria Integrata di Verona — Verona

France · 4 centers

• Amrois Paré Hospital (APHP) — Boulogne
• Service de Chirurgie Vasculaire et Endovasculaire CHU Gabriel-Montpied 58 rue Montalembert — Clermont-Ferrand
• Hospices Civils de lyon - Hôpital Edouard Herriot — Lyon
• Centre Hospitalier Universitaire de Rennes — Rennes

Germany · 4 centers

• University Hospital RWTH Aachen — Aachen
• University Hospital Leipzig — Leipzig
• Klinikum der Technischen Universität München — München
• Martin Austermann — Münster

Belgium · 3 centers

• CRC thoracic Vascular Surgery, ZOL Genk — Genk
• Universitair Ziekenhuis Gent, Thoracale en vasculaire heelkunde — Ghent
• Jessa Ziekenhuis — Hasselt

Netherlands · 2 centers

• VUMC Amsterdam — Amsterdam
• Catharina Ziekenhuis — Eindhoven

Spain · 2 centers

• Hospital Ramon Y Cajal — Madrid
• HOSPITAL CLINICO UNIVERSITARIO Valladolid — Valladolid

Austria · 1 center

• Hospital Ottakring, Institute for Vascular Surgery — Vienna

Poland · 1 center

• National Institute of Cardiology Warzwa — Warsaw

Switzerland · 1 center

• Inselspital Bern, Universitätsklinik für Gefässchirurgie — Bern

Identifiers

NCT: NCT04503395 · FCRE-191125

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗