Aortic Aneurysm, Abdominal
Conditions
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).
Interventions
DEVICEESAR treatment: Endograft + Heli-FX Endoanchor
ESAR treatment: Endurant II or Endurant IIs endograft + Heli-FX Endoanchor
DEVICEFEVAR treatment : Fenestrated endograft
Cook Zenith Fenestrated Graft or the Terumo Fenestrated Anaconda Graft
Sponsors
FCRE (Foundation for Cardiovascular Research and Education)
Medtronic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
comparision of two different procedure to repair abdominal aortic aneurysms with short necks
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness Endpoint - Technical Success | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Total contrast volume (ml) at index procedure | at index procedure | Total contrast volume (mL) at index procedure |
| Total fluoroscopy time (minutes) at index procedure | at index procedure | Total fluoroscopy time (minutes) at index procedure |
| Duration (minutes) of index procedure | 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 EndoAnchor implants as assessed by the Core Lab | at index procedure | Adequate penetration of EndoAnchor implants as assessed by the Core Lab |
| Clinical success | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. |
Countries
Austria, Belgium, France, Germany, Italy, Netherlands, Poland, Spain, Switzerland, United States
Contacts
CONTACTKarlotta Knuth
PRINCIPAL_INVESTIGATORGiovanni Torsello, Prof. Dr.
Vascupedia
PRINCIPAL_INVESTIGATORBrant Ullery, MD, MBA
Medical Director, Vascular Surgery Providence Heart and Vascular Institute
Outcome results
None listed