ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES

Aortic Aneurysm, Abdominal Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04503395
• Other study ID #: FCRE-191125
• Status: Recruiting
• Phase: N/A
• Start date: May 21, 2021
• Est. completion date: June 1, 2028

Study information

• Verified date: March 2023
• Source: FCRE (Foundation for Cardiovascular Research and Education)
• Contact: Annelena Held-Wehmöller, PhD
• Phone: +49 15785128140
• Email: info[@]fcre.eu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 204
• Est. completion date: June 1, 2028
• Est. primary completion date: June 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 and effective standard EVAR

• Subject is able and willing to comply with the protocol and to adhere to the follow-up requirements.

• Subject has provided written informed consent

• 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.

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

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

Locations

Country	Name	City	State
Austria	Hospital Ottakring, Institute for Vascular Surgery	Vienna
Belgium	CRC thoracic Vascular Surgery, ZOL Genk	Genk
Belgium	Universitair Ziekenhuis Gent, Thoracale en vasculaire heelkunde	Gent
France	Amrois Paré Hospital (APHP)	Boulogne
France	Service de Chirurgie Vasculaire et Endovasculaire CHU Gabriel-Montpied 58 rue Montalembert	Clermont Ferrand
France	Hospices Civils de lyon - Hôpital Edouard Herriot	Lyon
France	Centre Hospitalier Universitaire de Rennes	Rennes
Germany	University Hospital RWTH Aachen	Aachen
Germany	University Hospital Leipzig	Leipzig
Germany	University Hospital LMU Munich	Munich
Germany	Martin Austermann	Münster
Germany	University Hospital Regensburg	Regensburg
Italy	University of Bologna, IRCCS S. Orsola Hospital,	Bologna
Italy	IRCCS Ospedale San Raffaele, Chirurgia Vascolare	Milano
Italy	Vascular Endovascular Surgery University of Perugia;	Perugia
Netherlands	VUMC Amsterdam	Amsterdam
Netherlands	Catharina Ziekenhuis	Eindhoven
Spain	Hospital Ramon Y Cajal	Madrid
Spain	Hospital Universitario Donostia	San Sebastián
Switzerland	Inselspital Bern, Universitätsklinik für Gefässchirurgie	Bern

Sponsors (2)

Lead Sponsor	Collaborator
FCRE (Foundation for Cardiovascular Research and Education)	Medtronic

Countries where clinical trial is conducted

Austria,  Belgium,  France,  Germany,  Italy,  Netherlands,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness Endpoint - Technical Success	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.	through 12 months post-procedure
Primary	Safety Endpoint - Freedom from Major Adverse Events	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	through 30 days post-procedure
Secondary	Total contrast volume (ml) at index procedure	Total contrast volume (mL) at index procedure	at index procedure
Secondary	Total fluoroscopy time (minutes) at index procedure	Total fluoroscopy time (minutes) at index procedure	at index procedure
Secondary	Duration (minutes) of index procedure	3. Duration (minutes) of index procedure (time between initial skin access to final closure of the last artery access site)	at index procedure
Secondary	Adequate penetration of endo anchors as accessed by the Core Lab	Adequate penetration of endo anchors as accessed by the Core Lab	at index procedure
Secondary	Clinical success	7. Clinical success defined as technical success + freedom from intra-operative death and freedom from type IA/III endoleak in the first post-op image within 30 days.	through 30 days post-procedure
Secondary	Visceral artery patency or occlusion at 1, 12, 24 and 36 months follow-up	Visceral artery patency or occlusion at 1, 12, 24 and 36 months follow-up	through 1,12,24 and 36-months post-op
Secondary	Freedom from type Ia and III endoleaks at 1, 12, 24 and 36 months follow-up	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
Secondary	Freedom from aneurysm related secondary reinterventions at 1, 12, 24 and 36 months follow-up	Freedom from aneurysm related secondary reinterventions at 1, 12, 24 and 36 months follow-up	through 1,12,24 and 36-months post-op
Secondary	Freedom from aneurysm related mortality at 1, 12, 24 and 36 months follow-up	Freedom from aneurysm related mortality at 1, 12, 24 and 36 months follow-up	through 1,12,24 and 36-months post-op
Secondary	Freedom from stent graft migration (>10mm change from 1-month follow-up imaging) at 12, 24 and 36 months follow-up	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
Secondary	Sac dynamics (>5mm change from 1-month follow-up imaging): increase, stable, decrease at 12, 24, and 36 months follow-up	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
Secondary	Freedom from conversion to open repair at 1, 12, 24 and 36 months follow-up	Freedom from conversion to open repair at 1, 12, 24 and 36 months follow-up	through 1,12,24 and 36-months post-op
Secondary	Freedom from AAA rupture at 1, 12, 24 and 36 months follow-up	Freedom from AAA rupture at 1, 12, 24 and 36 months follow-up	through 1,12,24 and 36-months post-op
Secondary	Overall SCI rate, include transient events at 1 and 12 months follow-up	Overall SCI rate, include transient events at 1 and 12 months follow-up	through 1 and 12 months post-op
Secondary	Freedom from aortic neck-related secondary interventions	reinterventions for Type IAa endoleak, migration of the proximal stent graft, and progression of disease in the infrarenal aortic neck; progression of disease is defined as enlargement of the infrarenal aortic neck compared to the first postprocedural CT scan, as measured by either diameter, surface and/or volume.	at 1-, 12-, 24- and 36-months follow-up