Informations générales (source: ClinicalTrials.gov)
Physician Initiated Trial Investigating ESAR (EVAR Plus Heli-FX EndoAnchors) and FEVAR for the Treatment of Aortic Aneurysms With Short Infrarenal Aortic Neck (SOCRATES)
Interventional
N/A
FCRE (Foundation for Cardiovascular Research and Education) (Voir sur ClinicalTrials)
mai 2021
juin 2028
01 mai 2025
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).
Etablissements
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Amrois Paré Hospital (APHP) - Boulogne - France | Raphael Coscas | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Universitaire de Rennes - Rennes - France | Adrien Kaladji | Contact (sur clinicalTrials) | |||
| Hospices Civils de lyon - Hôpital Edouard Herriot - Lyon - France | Antoine Millon | Contact (sur clinicalTrials) | |||
| Service de Chirurgie Vasculaire et Endovasculaire CHU Gabriel-Montpied 58 rue Montalembert - 63003 - Clermont Ferrand - France | Fabien Thaveau | Contact (sur clinicalTrials) | |||
Critères
Tous
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°
- 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°
- 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.