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Prospective, non-randomized, multi-center clinical investigation of the NEXUSâ„¢ Aortic Arch Stent Graft System (NEXUSTM) for the treatment of thoracic aortic lesions involving the aortic arch with a proximal landing zone, native or previously implanted surgical graft, in the ascending aorta and with a brachiocephalic trunk native landing zone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chronic Dissection (arm closed to enrollment) | Experimental |
| |
| Penetrating Aortic Ulcer and/or Intramural Hematoma | Experimental |
| |
| Aneurysm (arm closed to enrollment) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NEXUS Aortic Stent Graft System | Device | Arch Stent Graft, whose cranial narrow end is intended to be deployed into the Brachiocephalic artery and whose distal end is intended to be deployed into the Descending Thoracic Aorta. Ascending Stent Graft intended to be deployed in the Ascending Aorta. OPTIONAL: Descending Extension can be used in case the aortic lesion elongates further distally and out of the covered length offered by the Arch Stent Graft. Multiple Descending Extensions can be used if needed to cover the entire length of the lesion. |
| Measure | Description | Time Frame |
|---|---|---|
| Device Technical Failure |
| 30 Days |
| Clinical Failure | Subjects experiencing early mortality or at least one of the following MAEs through 30-Day of Phase 1 Procedure and 30-Day of Index Procedure: Disabling stroke, permanent paralysis/paraplegia, renal failure, aortic rupture, development of new dissections in the thoracic aorta or brachiocephalic artery. | 30 Days |
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Inclusion Criteria:
Male and female age ≥ 18.
Proximal/ascending native or previously implanted surgical graft landing zone of appropriate length
Proximal/ascending native or previously implanted surgical graft landing zone of appropriate diameter
Distal/descending native landing zone of appropriate length
Distal/descending native landing zone of appropriate diameter
Brachiocephalic trunk native landing zone of appropriate length
Brachiocephalic trunk native landing zone of appropriate diameter
Appropriate take off angle between the Brachiocephalic Artery and the Aortic Arch perpendicular
Appropriate aortic arch perpendicular diameter
Chronic dissection with at least one of the following conditions:
Aneurysm with at least one of the following conditions:
Penetrating aortic ulcer with at least one of the following:
Intramural hematoma with at least one of the following:
In the event of a lesion in the ascending aortic, the proximal/ascending native or previously implanted surgical graft the landing zone must be appropriate
Femoral / iliac artery diameter as documented by CTA or MRA that allows endovascular access to the diseased site with a 20 Fr. delivery catheter.
Access vessels morphology suitable for endovascular repair in terms of tortuosity, calcification and angulation, documented by CTA/MRA.
Brachial/Axial Artery diameter that allows endovascular access suitable for 7 Fr.
Subject is considered an appropriate candidate for an elective surgery.
Subject is considered to be at high risk for open repair, as determined by the investigator.
Access vessels, iliac/femoral & brachial/axillary compatible with vascular access techniques (femoral cutdown or percutaneous), devices, and /or accessories.
Subject is willing and able to comply with procedures specified in the protocol and is able to return for follow-up visits as specified by the protocol.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jessica Kleine | Contact | +1 (612) 280-0208 | j.kleine@endospan.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama Birmingham | Recruiting | Birmingham | Alabama | 35294 | United States |
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| University of California San Diego Medical Center | Recruiting | La Jolla | California | 92037 | United States |
|
| UC Davis Health | Completed | Sacramento | California | 95817 | United States |
| Stanford University School of Medicine | Recruiting | Stanford | California | 94305 | United States |
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| University of Colorado | Recruiting | Aurora | Colorado | 80045 | United States |
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| Hartford Hospital | Recruiting | Hartford | Connecticut | 06102 | United States |
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| MedStar Washington Hospital | Recruiting | Washington D.C. | District of Columbia | 20010 | United States |
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| Advent Health Orlando | Completed | Orlando | Florida | 32804 | United States |
| Emory University | Recruiting | Atlanta | Georgia | 30322 | United States |
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| The University of Chicago | Recruiting | Chicago | Illinois | 60637 | United States |
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| Ascension St. Vincent | Completed | Carmel | Indiana | 46290 | United States |
| University of Maryland | Recruiting | Baltimore | Maryland | 21201 | United States |
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| Tufts Medical Center | Completed | Boston | Massachusetts | 02111 | United States |
| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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| Washington University School of Medicine | Recruiting | St Louis | Missouri | 63110 | United States |
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| The Mount Sinai Medical Center | Recruiting | New York | New York | 10029 | United States |
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| Northwell Health Lenox Hill Hospital | Recruiting | New York | New York | 10075 | United States |
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| University of North Carolina | Recruiting | Chapel Hill | North Carolina | 27599 | United States |
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| Atrium Health | Recruiting | Charlotte | North Carolina | 28203 | United States |
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| Duke University Medical Center | Completed | Durham | North Carolina | 27710 | United States |
| The Lindner Research Center | Recruiting | Cincinnati | Ohio | 45219 | United States |
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| University Hospitals of Cleveland | Recruiting | Cleveland | Ohio | 44106 | United States |
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| Oregon Health | Recruiting | Portland | Oregon | 97239 | United States |
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| University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| Lankenau Medical Center | Completed | Wynnewood | Pennsylvania | 19096 | United States |
| Medical University of South Carolina | Recruiting | Charleston | South Carolina | 29425 | United States |
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| Ballad Health | Completed | Kingsport | Tennessee | 37660 | United States |
| Vanderbilt University Medical Center | Recruiting | Nashville | Tennessee | 37232 | United States |
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| Baylor Scott and White | Recruiting | Plano | Texas | 75093 | United States |
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| Sentara Norfolk General Hospital | Recruiting | Norfolk | Virginia | 23507 | United States |
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| Carilion Clinic | Recruiting | Roanoke | Virginia | 24014 | United States |
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| Auckland City Hospital | Recruiting | Auckland | Grafton | 1023 | New Zealand |
|
| ID | Term |
|---|---|
| D000784 | Aortic Dissection |
| D001014 | Aortic Aneurysm |
| D000094667 | Penetrating Atherosclerotic Ulcer |
| ID | Term |
|---|---|
| D000094665 | Dissection, Blood Vessel |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000094683 | Acute Aortic Syndrome |
| D001018 | Aortic Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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