PMEG for Repair of Pararenal and Thoracoabdominal Aortic Aneurysm

Part of paid clinical trials in Tampa, Florida.

Sponsor
Konstantinos Dean Arnaoutakis, MD
Study ID
NCT05195905
Status
Recruiting
Apply to this trial

Conditions

  • Pararenal Aortic Aneurysm
  • Thoracoabdominal Aortic Aneurysm

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PMEG — DEVICE
    All devices that will be modified in this study protocol are commercially available in the United States. The commercially available endografts will be used to construct a fenestrated/branched device for this intervention.

Study Details

The primary objective is to evaluate the safety and effectiveness of surgeon modified endografts for the treatment of pararenal and thoracoabdominal aortic pathology in patients who are not candidate for traditional open repair due to comorbid issues and their anatomy is not amenable to commercially available endografts.

Key Dates

Start date
Jun 6, 2023
Status verified
Apr 2025
Primary completion
Feb 28, 2029
Completion
Aug 31, 2029

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Physician-modified endografts
    For this clinical protocol, endografts which are commercially available will be modified in a sterile fashion on a back-table in the operating room.

Primary Outcome Measure

Number of subjects with 30-day major adverse events from primary procedure [ Time Frame: Day 30 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Tampa General HospitalTampaFlorida33606
Beth Montera
[email protected]
813-844-7948
Cara Grzybowski
[email protected]
813-844-7948
Konstantinos Arnaoutakis, MD (PRINCIPAL_INVESTIGATOR)
University of South Florida - South Tampa CampusTampaFlorida33606
Beth Montera
[email protected]
813-844-7948
Cara Grzybowski, BS
[email protected]
8138447873
Konstantinos Arnaoutakis, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Tampa, FL

By research site
Tampa General Hospital· Tampa, FLUniversity of South Florida - South Tampa Campus· Tampa, FL

Related Studies