ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES (SOCRATES)

• ClinicalTrials.gov Identifier: NCT04503395
• Recruitment Status: Recruiting
• First Posted: August 7, 2020
• Last Update Posted: March 17, 2023
• Sponsor: FCRE (Foundation for Cardiovascular Research and Education)
• Collaborator: Medtronic
• Information provided by (Responsible Party): Dr. Sabrina Overhagen, FCRE (Foundation for Cardiovascular Research and Education)

Tracking Information

• First Submitted Date: July 22, 2020
• First Posted Date: August 7, 2020
• Last Update Posted Date: March 17, 2023
• Actual Study Start Date: May 21, 2021
• Estimated Primary Completion Date: June 1, 2026 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 4, 2020)

• 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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 15, 2023)

• Total contrast volume (ml) at index procedure [ Time Frame: at index procedure ]
  Total contrast volume (mL) at index procedure
• Total fluoroscopy time (minutes) at index procedure [ Time Frame: at index procedure ]
  Total fluoroscopy time (minutes) at index procedure
• Duration (minutes) of index procedure [ Time Frame: at index procedure ]
  3. Duration (minutes) of index procedure (time between initial skin access to final closure of the last artery access site)
• Adequate penetration of endo anchors as accessed by the Core Lab [ Time Frame: at index procedure ]
  Adequate penetration of endo anchors as accessed by the Core Lab
• Clinical success [ Time Frame: through 30 days post-procedure ]
  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.
• 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 ]
  Visceral artery patency or occlusion 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 [ 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
• 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 secondary reinterventions at 1, 12, 24 and 36 months follow-up
• 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 aneurysm related mortality at 1, 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 [ Time Frame: through 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
• 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 ]
  Sac dynamics (>5mm change from 1-month follow-up imaging): increase, stable, decrease at 12, 24, and 36 months follow-up
• 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 ]
  Freedom from conversion to open repair at 1, 12, 24 and 36 months follow-up
• Freedom from AAA rupture at 1, 12, 24 and 36 months follow-up [ Time Frame: through 1,12,24 and 36-months post-op ]
  Freedom from AAA rupture at 1, 12, 24 and 36 months follow-up
• Overall SCI rate, include transient events at 1 and 12 months follow-up [ Time Frame: through 1 and 12 months post-op ]
  Overall SCI rate, include transient events at 1 and 12 months follow-up
• Freedom from aortic neck-related secondary interventions [ Time Frame: at 1-, 12-, 24- and 36-months follow-up ]
  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.

Original Secondary Outcome Measures (submitted: August 4, 2020)

• Total contrast volume (ml) at index procedure [ Time Frame: at index procedure ]
  Total contrast volume (mL) at index procedure
• Total fluoroscopy time (minutes) at index procedure [ Time Frame: at index procedure ]
  Total fluoroscopy time (minutes) at index procedure
• Duration (minutes) of index procedure [ Time Frame: at index procedure ]
  3. Duration (minutes) of index procedure (time between initial skin access to final closure of the last artery access site)
• Adequate penetration of endo anchors as accessed by the Core Lab [ Time Frame: at index procedure ]
  Adequate penetration of endo anchors as accessed by the Core Lab
• Clinical success [ Time Frame: through 30 days post-procedure ]
  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.
• 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 ]
  Visceral artery patency or occlusion 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 [ 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
• 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 secondary reinterventions at 1, 12, 24 and 36 months follow-up
• 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 aneurysm related mortality at 1, 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 [ Time Frame: through 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
• 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 ]
  Sac dynamics (>5mm change from 1-month follow-up imaging): increase, stable, decrease at 12, 24, and 36 months follow-up
• 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 ]
  Freedom from conversion to open repair at 1, 12, 24 and 36 months follow-up
• Freedom from AAA rupture at 1, 12, 24 and 36 months follow-up [ Time Frame: through 1,12,24 and 36-months post-op ]
  Freedom from AAA rupture at 1, 12, 24 and 36 months follow-up
• Overall SCI rate, include transient events at 1 and 12 months follow-up [ Time Frame: through 1 and 12 months post-op ]
  Overall SCI rate, include transient events at 1 and 12 months follow-up

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

comparision of two different procedure to repair abdominal aortic aneurysms with short necks

Masking: None (Open Label)
Primary Purpose: Treatment

• Condition: Aortic Aneurysm, Abdominal

Intervention

• 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

Study Arms

• Experimental: ESAR
  Endovascular Aneurysm Repair + Heli-FX EndoAnchors
  Intervention: Device: ESAR treatment: Endograft + Heli-FX Endoanchor
• Active Comparator: FEVAR
  Fenestrated EndoVascular Aneurysm Repair
  Intervention: Device: FEVAR treatment : Fenestrated endograft

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 4, 2020): 204
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 1, 2028
• Estimated Primary Completion Date: June 1, 2026 (Final data collection date for primary outcome measure)

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 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Annelena Held-Wehmöller, PhD; +49 15785128140; info@fcre.eu

Contact: Sarah Litterscheid; +49 15785319015; sarah.litterscheid@fcre.eu

• Listed Location Countries: Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Switzerland

Administrative Information

• NCT Number: NCT04503395
• Other Study ID Numbers: FCRE-191125
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Dr. Sabrina Overhagen, FCRE (Foundation for Cardiovascular Research and Education)
• Original Responsible Party: Prof. Giovanni Torsello, FCRE (Foundation for Cardiovascular Research and Education), Principal Investigator
• Current Study Sponsor: FCRE (Foundation for Cardiovascular Research and Education)
• Original Study Sponsor: Prof. Giovanni Torsello
• Collaborators: Medtronic

Investigators

• Principal Investigator: Giovanni Torsello, Prof. Dr.; Vascupedia
• Principal Investigator: Brant Ullery, MD, MBA; Medical Director, Vascular Surgery Providence Heart and Vascular Institute

• PRS Account: FCRE (Foundation for Cardiovascular Research and Education)
• Verification Date: March 2023