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New treatment option for Aortic Aneurysm, Abdominal
Official title ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES
ClinicalTrials.gov ID: NCT04503395
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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 Subject meets the other anatomical requirements according to the locally applicable...
You likely can't join if
- 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
See the full eligibility 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...
- 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 Subject meets the other anatomical requirements according to the locally applicable Endurant II/IIs stent graft system, Heli-FX EndoAnchor system, Terumo...
- 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°
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- La Jolla, California, United States
- Stanford, California, United States
- Gainesville, Florida, United States
- Grand Rapids, Michigan, United States
- New York, New York, United States
- Tulsa, Oklahoma, United States
- Portland, Oregon, United States
- Pittsburgh, Pennsylvania, United States
- Norfolk, Virginia, United States
- Vienna, Austria
- Genk, Belgium
- Ghent, Belgium
- Hasselt, Belgium
- Boulogne, France
- Clermont-Ferrand, France
- Lyon, France
- Rennes, France
- Aachen, Germany
- Leipzig, Germany
- München, Germany
+ 13 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include La Jolla, California, United States; Stanford, California, United States; Gainesville, Florida, United States; Grand Rapids, Michigan, United States; New York, New York, United States; Tulsa, Oklahoma, United States and 27 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.