Comparing two methods for treating short neck abdominal aortic aneurysms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized study aims to evaluate the safety and effectiveness of two different endovascular techniques for treating abdominal aortic aneurysms with short aortic necks, specifically EndoVascular Aneurysm Repair (ESAR) using the Endurant + Heli-FX EndoAnchor system and Fenestrated Endovascular Aneurysm Repair (FEVAR) using customizable grafts. Participants will be selected based on specific anatomical criteria that make them unsuitable for standard EVAR procedures. The study will involve a comparison of outcomes between the two treatment methods to determine which is more effective for this challenging patient population.

Why it matters

Who can join: the full rules

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.

Where it's running

• UCSD Medical Center Hillcrest
  La Jolla, California, United States Recruiting
• Stanford University
  Stanford, California, United States Recruiting
• University of Florida
  Gainesville, Florida, United States Recruiting
• Corewell Health (Spectrum)
  Grand Rapids, Michigan, United States Recruiting
• Mount Sinai Hospital
  New York, New York, United States Recruiting
• Oklahoma Heart
  Tulsa, Oklahoma, United States Recruiting

Study contacts

• Principal investigator: Giovanni Torsello, Prof. Dr. — Vascupedia
• Study coordinator: Karlotta Knuth
• Email: info@fcre.eu
• Phone: +4915785318893

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.