ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES (SOCRATES)
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| ClinicalTrials.gov Identifier: NCT04503395 |
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Recruitment Status :
Recruiting
First Posted : August 7, 2020
Last Update Posted : March 17, 2023
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Sponsor:
FCRE (Foundation for Cardiovascular Research and Education)
Collaborator:
Medtronic
Information provided by (Responsible Party):
Dr. Sabrina Overhagen, FCRE (Foundation for Cardiovascular Research and Education)
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Brief Summary:
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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Aortic Aneurysm, Abdominal | Device: ESAR treatment: Endograft + Heli-FX Endoanchor Device: FEVAR treatment : Fenestrated endograft | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 204 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | comparision of two different procedure to repair abdominal aortic aneurysms with short necks |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Physician Initiated Trial Investigating ESAR (EVAR Plus Heli-FX EndoAnchors) and FEVAR for the Treatment of Aortic Aneurysms With Short Infrarenal Aortic Neck |
| Actual Study Start Date : | May 21, 2021 |
| Estimated Primary Completion Date : | June 1, 2026 |
| Estimated Study Completion Date : | June 1, 2028 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: ESAR
Endovascular Aneurysm Repair + Heli-FX EndoAnchors
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Device: ESAR treatment: Endograft + Heli-FX Endoanchor
ESAR treatment: Endurant II or Endurant IIs endograft + Heli-FX Endoanchor |
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Active Comparator: FEVAR
Fenestrated EndoVascular Aneurysm Repair
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Device: FEVAR treatment : Fenestrated endograft
Cook Zenith Fenestrated Graft or the Terumo Fenestrated Anaconda Graft |
Primary Outcome Measures :
- Effectiveness Endpoint - Technical Success [ Time Frame: through 12 months post-procedure ]Composite of technical success at index procedure, and freedom from type IA or type III endoleak, freedom from aneurysm related mortality (ARM), and freedom from secondary reinterventions through 12 months post index procedure.
- Safety Endpoint - Freedom from Major Adverse Events [ Time Frame: through 30 days post-procedure ]Freedom from MAE through 30 days post index procedure. MAE defined as: All-Cause-Mortality, Bowel Ischemia, Myocardial Infraction, Procedural Blood Loss > 1000cc, Access related complications, permanent paraplegia and paraparesis at 30 days, disabling stroke, respiratory failure, or renal complications
Secondary Outcome Measures :
- Total contrast volume (ml) at index procedure [ Time Frame: at index procedure ]Total contrast volume (mL) at index procedure
- Total fluoroscopy time (minutes) at index procedure [ Time Frame: at index procedure ]Total fluoroscopy time (minutes) at index procedure
- Duration (minutes) of index procedure [ Time Frame: at index procedure ]3. Duration (minutes) of index procedure (time between initial skin access to final closure of the last artery access site)
- Adequate penetration of endo anchors as accessed by the Core Lab [ Time Frame: at index procedure ]Adequate penetration of endo anchors as accessed by the Core Lab
- Clinical success [ Time Frame: through 30 days post-procedure ]7. Clinical success defined as technical success + freedom from intra-operative death and freedom from type IA/III endoleak in the first post-op image within 30 days.
- Visceral artery patency or occlusion at 1, 12, 24 and 36 months follow-up [ Time Frame: through 1,12,24 and 36-months post-op ]Visceral artery patency or occlusion at 1, 12, 24 and 36 months follow-up
- Freedom from type Ia and III endoleaks at 1, 12, 24 and 36 months follow-up [ Time Frame: through 1,12,24 and 36-months post-op ]Freedom from type Ia and III endoleaks at 1, 12, 24 and 36 months follow-up
- Freedom from aneurysm related secondary reinterventions at 1, 12, 24 and 36 months follow-up [ Time Frame: through 1,12,24 and 36-months post-op ]Freedom from aneurysm related secondary reinterventions at 1, 12, 24 and 36 months follow-up
- Freedom from aneurysm related mortality at 1, 12, 24 and 36 months follow-up [ Time Frame: through 1,12,24 and 36-months post-op ]Freedom from aneurysm related mortality at 1, 12, 24 and 36 months follow-up
- Freedom from stent graft migration (>10mm change from 1-month follow-up imaging) at 12, 24 and 36 months follow-up [ Time Frame: through 12,24 and 36-months post-op ]Freedom from stent graft migration (>10mm change from 1-month follow-up imaging) at 12, 24 and 36 months follow-up
- Sac dynamics (>5mm change from 1-month follow-up imaging): increase, stable, decrease at 12, 24, and 36 months follow-up [ Time Frame: through 12,24 and 36-months post-op ]Sac dynamics (>5mm change from 1-month follow-up imaging): increase, stable, decrease at 12, 24, and 36 months follow-up
- Freedom from conversion to open repair at 1, 12, 24 and 36 months follow-up [ Time Frame: through 1,12,24 and 36-months post-op ]Freedom from conversion to open repair at 1, 12, 24 and 36 months follow-up
- Freedom from AAA rupture at 1, 12, 24 and 36 months follow-up [ Time Frame: through 1,12,24 and 36-months post-op ]Freedom from AAA rupture at 1, 12, 24 and 36 months follow-up
- Overall SCI rate, include transient events at 1 and 12 months follow-up [ Time Frame: through 1 and 12 months post-op ]Overall SCI rate, include transient events at 1 and 12 months follow-up
- Freedom from aortic neck-related secondary interventions [ Time Frame: at 1-, 12-, 24- and 36-months follow-up ]reinterventions for Type IAa endoleak, migration of the proximal stent graft, and progression of disease in the infrarenal aortic neck; progression of disease is defined as enlargement of the infrarenal aortic neck compared to the first postprocedural CT scan, as measured by either diameter, surface and/or volume.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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 and effective standard EVAR
- Subject is able and willing to comply with the protocol and to adhere to the follow-up requirements.
- Subject has provided written informed consent
- 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
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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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04503395
Contacts
| Contact: Annelena Held-Wehmöller, PhD | +49 15785128140 | info@fcre.eu | |
| Contact: Sarah Litterscheid | +49 15785319015 | sarah.litterscheid@fcre.eu |
Locations
Show 20 study locations
Sponsors and Collaborators
FCRE (Foundation for Cardiovascular Research and Education)
Medtronic
Investigators
| Principal Investigator: | Giovanni Torsello, Prof. Dr. | Vascupedia | |
| Principal Investigator: | Brant Ullery, MD, MBA | Medical Director, Vascular Surgery Providence Heart and Vascular Institute |
| Responsible Party: | Dr. Sabrina Overhagen, Principal Investigator, FCRE (Foundation for Cardiovascular Research and Education) |
| ClinicalTrials.gov Identifier: | NCT04503395 |
| Other Study ID Numbers: |
FCRE-191125 |
| First Posted: | August 7, 2020 Key Record Dates |
| Last Update Posted: | March 17, 2023 |
| Last Verified: | March 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal |
Vascular Diseases Cardiovascular Diseases Aortic Diseases |