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Comparing two methods for treating short neck abdominal aortic aneurysms

Physician Initiated Trial Investigating ESAR (EVAR Plus Heli-FX EndoAnchors) and FEVAR for the Treatment of Aortic Aneurysms With Short Infrarenal Aortic Neck

NA · FCRE (Foundation for Cardiovascular Research and Education) · NCT04503395

This study is testing two different ways to treat abdominal aortic aneurysms in patients with short necks to see which method works better and is safer for them.

Quick facts

PhaseNA
Study typeInterventional
Enrollment204 (estimated)
Ages18 Years and up
SexAll
SponsorFCRE (Foundation for Cardiovascular Research and Education) (other)
Locations32 sites (La Jolla, California and 31 other locations)
Trial IDNCT04503395 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with specific anatomical conditions that prevent them from undergoing standard EVAR procedures.

Not a fit: Patients who do not have short neck abdominal aortic aneurysms or those who are suitable candidates for standard EVAR may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safer and more effective treatment option for patients with short neck abdominal aortic aneurysms.

How similar studies have performed: Other studies have shown promise in using similar endovascular techniques for challenging aneurysm anatomies, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion 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, 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 this trial is running

La Jolla, California and 31 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Aortic Aneurysm, Abdominal

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.