ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES
Recruiting
N/AInterventional Study
Aortic Aneurysm, Abdominal
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
204 (estimated)
Sponsor
FCRE (Foundation for Cardiovascular Research and Education) · Other
Who this trial is looking for
This trial is looking for adults who need treatment for a specific type of abdominal aortic aneurysm. Participants will receive different medical device treatments and will be monitored for safety and effectiveness.
Are You a Good Fit for This Trial?
You may be able to join if
I am over 18 years old.
I have been diagnosed with an abdominal aortic aneurysm.
My aorta has a healthy area above the aneurysm that is 4 to 15 mm long.
I am not eligible for standard endovascular repair due to my anatomy.
I am able to follow the trial requirements.
I have given my written consent.
You may not be able to join if
I am currently participating in another study.
I expect to live less than 2 more years.
I am a female who could become pregnant.
I have severe kidney problems or require dialysis.
I have had a heart attack or stroke in the last 3 months.
I have a known connective tissue disease.
I have had previous surgery for an abdominal aortic aneurysm.
I have a history of active infection or COVID-19.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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).
Trial Locations
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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 than1…
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.
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