Duke Customized Aortic Aneurysm Repair With Endovascular Stent-grafts - Duke CARES Trial

Conditions

• Aortic Disorders

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Physician Modified Endovascular Graft — DEVICE
  The participant's surgeon will modify a commercially available graft tailored to their anatomy for their surgery. All components used to create the final device (PMEG), made specifically for each participant and tailored to their individual anatomy, are FDA-approved, although the final graft itself (the PMEG) is considered investigational.

Study Details

The purpose of this study is to see if physician modified endovascular grafts (PMEG) can be used safely for the treatment of aortic disorders. The surgeon will modify a commercially available graft tailored to the participant's anatomy for surgery. The researchers will follow participants for 5 years, which will require regular visits to the clinic for follow-up imaging and follow-up blood tests.

Key Dates

Start date

Jan 13, 2026

Status verified

Jan 2026

Primary completion

Dec 11, 2030

Completion

Dec 11, 2031

Study Design

Enrollment

30 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Physician Modified Endovascular Graft
  The participant's surgeon will modify a commercially available graft tailored to their anatomy for their surgery.

Primary Outcome Measure

Incidence of major adverse events (MAE) [ Time Frame: 30 days, or during hospitalization if this exceeds 30 days ]

Central Contacts

• Ellen R Burkett, MSHS
  9196811878
  [email protected]

Locations (1)

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