Endovascular Repair for Abdominal Aortic Aneurysm

ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES

Recruiting N/A Interventional 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.

Check Your Eligibility
About This Trial

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…
Contacts

Karlotta Knuth

+4915785318893

info@fcre.eu

CONTACT