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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ESAR | Experimental | Endovascular Aneurysm Repair + Heli-FX EndoAnchors |
|
| FEVAR | Active Comparator | Fenestrated EndoVascular Aneurysm Repair |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ESAR treatment: Endograft + Heli-FX Endoanchor | Device | ESAR treatment: Endurant II or Endurant IIs endograft + Heli-FX Endoanchor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness Endpoint - Technical Success | 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. | through 12 months post-procedure |
| Safety Endpoint - Freedom from Major Adverse Events | 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 | through 30 days post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Total contrast volume (ml) at index procedure | Total contrast volume (mL) at index procedure | at index procedure |
| Total fluoroscopy time (minutes) at index procedure | Total fluoroscopy time (minutes) at index procedure |
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Inclusion Criteria:
CT Angiographic Inclusion Criteria
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:
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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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karlotta Knuth | Contact | +4915785318893 | info@fcre.eu |
| Name | Affiliation | Role |
|---|---|---|
| Giovanni Torsello, Prof. Dr. | Vascupedia | Principal Investigator |
| Brant Ullery, MD, MBA | Medical Director, Vascular Surgery Providence Heart and Vascular Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSD Medical Center Hillcrest | Recruiting | La Jolla | California | 92037 | United States | |
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comparision of two different procedure to repair abdominal aortic aneurysms with short necks
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| FEVAR treatment : Fenestrated endograft | Device | Cook Zenith Fenestrated Graft or the Terumo Fenestrated Anaconda Graft |
|
| at index procedure |
| Duration (minutes) of index procedure | 3. Duration (minutes) of index procedure (time between initial skin access to final closure of the last artery access site) | at index procedure |
| Adequate penetration of EndoAnchor implants as assessed by the Core Lab | Adequate penetration of EndoAnchor implants as assessed by the Core Lab | at index procedure |
| Clinical success | 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. | through 30 days post-procedure |
| Visceral artery patency or occlusion at 1, 12, 24 and 36 months follow-up | Visceral artery patency or occlusion 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 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 aneurysm related secondary reinterventions 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 mortality 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 stent graft migration (>10mm change from 1-month follow-up imaging) at 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 |
| Sac dynamics (>5mm change from 1-month follow-up imaging): increase, stable, decrease 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 |
| Freedom from conversion to open repair at 1, 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 AAA rupture 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 |
| Overall SCI rate, include transient events at 1 and 12 months follow-up | Overall SCI rate, include transient events at 1 and 12 months follow-up | through 1 and 12 months post-op |
| Freedom from aortic neck-related secondary interventions | 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. | at 1-, 12-, 24- and 36-months follow-up |
| Stanford University |
| Recruiting |
| Stanford |
| California |
| 94305 |
| United States |
|
| University of Florida | Recruiting | Gainesville | Florida | 32608 | United States |
| Corewell Health (Spectrum) | Recruiting | Grand Rapids | Michigan | 49503 | United States |
| Mount Sinai Hospital | Recruiting | New York | New York | 10029 | United States |
|
| Oklahoma Heart | Recruiting | Tulsa | Oklahoma | 74104 | United States |
|
| Providence Portland Medical Center | Recruiting | Portland | Oregon | 97213 | United States |
| Allegheny General Hospital | Recruiting | Pittsburgh | Pennsylvania | 14212 | United States |
| Sentara Norfolk General Hospital | Recruiting | Norfolk | Virginia | 23507 | United States |
|
| Hospital Ottakring, Institute for Vascular Surgery | Recruiting | Vienna | 1160 | Austria |
|
| CRC thoracic Vascular Surgery, ZOL Genk | Recruiting | Genk | 3600 | Belgium |
|
| Universitair Ziekenhuis Gent, Thoracale en vasculaire heelkunde | Recruiting | Ghent | 9000 | Belgium |
|
| Jessa Ziekenhuis | Recruiting | Hasselt | 3500 | Belgium |
|
| Amrois Paré Hospital (APHP) | Recruiting | Boulogne | France |
|
| Service de Chirurgie Vasculaire et Endovasculaire CHU Gabriel-Montpied 58 rue Montalembert | Recruiting | Clermont-Ferrand | 63003 | France |
|
| Hospices Civils de lyon - Hôpital Edouard Herriot | Recruiting | Lyon | France |
|
| Centre Hospitalier Universitaire de Rennes | Recruiting | Rennes | France |
|
| University Hospital RWTH Aachen | Recruiting | Aachen | 52074 | Germany |
|
| University Hospital Leipzig | Recruiting | Leipzig | 04109 | Germany |
|
| Klinikum der Technischen Universität München | Recruiting | München | 81675 | Germany |
|
| Martin Austermann | Completed | Münster | 48145 | Germany |
| University of Bologna, IRCCS S. Orsola Hospital, | Recruiting | Bologna | 40138 | Italy |
|
| Az. Ospedaliera San Martino, Genova | Recruiting | Genova | 16132 | Italy |
|
| IRCCS Ospedale San Raffaele, Chirurgia Vascolare | Recruiting | Milan | 20132 | Italy |
|
| Vascular Endovascular Surgery University of Perugia; | Not yet recruiting | Perugia | 06100 | Italy |
|
| Az.Osped.Univers.S.Giovanni, Turin | Recruiting | Turin | 10154 | Italy |
|
| Azienda Ospedaliera Universitaria Integrata di Verona | Recruiting | Verona | Italy |
|
| VUMC Amsterdam | Not yet recruiting | Amsterdam | Netherlands |
|
| Catharina Ziekenhuis | Not yet recruiting | Eindhoven | Netherlands |
|
| National Institute of Cardiology Warzwa | Recruiting | Warsaw | 04-628 | Poland |
|
| Hospital Ramon Y Cajal | Recruiting | Madrid | Spain |
|
| HOSPITAL CLINICO UNIVERSITARIO Valladolid | Recruiting | Valladolid | 47003 | Spain |
|
| Inselspital Bern, Universitätsklinik für Gefässchirurgie | Not yet recruiting | Bern | 3010 | Switzerland |
|
| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
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