NEXUS Aortic Arch Clinical Study to Evaluate Safety and Effectiveness

Conditions

• Aortic Aneurysm
• Aortic Dissection
• Intramural Hematoma
• Penetrating Aortic Ulcer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

Prospective, non-randomized, multi-center clinical investigation of the NEXUS™ 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.

Key Dates

Start date

Oct 20, 2020

Status verified

Oct 2025

Primary completion

Oct 31, 2025

Completion

Oct 31, 2029

Study Design

Enrollment

110 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Chronic Dissection (arm closed to enrollment)
• Experimental: Penetrating Aortic Ulcer and/or Intramural Hematoma
• Experimental: Aneurysm (arm closed to enrollment)

Primary Outcome Measure

Device Technical Failure [ Time Frame: 30 Days ]

Central Contacts

• Jessica Kleine
  +1 (612) 280-0208
  [email protected]

Locations (31)

Find similar trials in Birmingham, AL

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