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SOCRATES

  • Status
    Accepting Candidates
  • Age
    18 Years - N/A
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

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).

Details

Full study title Physician Initiated Trial Investigating ESAR (EVAR plus Heli-FX EndoAnchors) and FEVAR for the Treatment of Aortic Aneurysms with Short Infrarenal Aortic Neck.
Protocol number OCR44303
ClinicalTrials.gov ID NCT04503395
Phase N/A

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 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.

Lead researcher

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  1. Step
    1

    Contact the research team

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    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

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  3. Step
    3

    Provide your consent to participate

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  4. Step
    4

    Participate

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