Frailty and Physician Modified Fenestrated Endograft for Thoracoabdominal Aortic Pathologies

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of Southern California
Study ID
NCT04524247
Status
Recruiting
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Conditions

  • Frailty Syndrome
  • Pararenal Aneurysm
  • Thoracoabdominal Aortic Aneurysm
  • Thoracoabdominal; Aortic, Aneurysm, Dissecting

Eligibility Criteria

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

Interventions

  • Physician Modified Endografts — DEVICE
    Modification procedure Description of modified device is detailed in Section 3.5 of IDE. In summary, the steps involved in modification of the Zenith Alpha thoracic stent grafts are; 1. Unsheathing of the stent graft 2. Retrieval of a trigger wire from the inner cannula of the delivery system 3. Rerouting of the trigger wire along the stent graft 4. Removal of proximal barbs. 5. Creation of fenestrations and/or branch cuffs 6. Placement of radiopaque markers around the fenestrations/ branch cuffs 7. Placement of temporary and/or permanent diameter constraining ties 8. (Optional) Placement of preloaded wires through the fenestrations/branch cuffs

Study Details

The primary objective of this single arm, prospective feasibility study, Impact of Frailty on Clinical Outcomes of Patients Treated for Thoracoabdominal and Complex Abdominal Aortic Aneurysms with Physician-Modified Fenestrated and Branched Stent Grafts, is to assess the use of the physician-modified fenestrated/branched endografts to repair thoracoabdominal and complex aortic aneurysms in subjects having appropriate anatomy, at high risks for open repairs. The primary intent of the study is to assess safety and preliminary effectiveness of the device acutely (i.e., treatment success and technical success), at 30 days (i.e., the rate of major adverse events (MAE)) and at 3 months, 6 months, 12 months, and annually to 5 years (i.e., the proportion of treatment group subjects that achieve and maintain treatment success). Additionally, this study will assess the degree of patient frailty before and after the aneurysm repair, as well as the association between the preoperative baseline frailty and clinical outcomes detailed above. This will help improve subject selection in identification of high risk patients who would not only suffer poor clinical outcomes, but also experience decline in their functional status.

Key Dates

Start date
Feb 23, 2021
Status verified
Jun 2024
Primary completion
Jul 2, 2028
Completion
Jul 2, 2032

Study Design

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

Arms

  • Experimental: PMEG FEVAR
    The only arm of this study will be enrolled subjects who undergo physician modified endografting as a treatment of their thoracoabdominal aortic aneurysms or complex abdominal aortic aneurysms.

Primary Outcome Measure

Rate of Major Adverse Events [ Time Frame: Immediately after the surgery up to 30 days. If the hospital stay exceeds 30 days, major adverse events that occur prior to discharge from hospital will be included. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Keck Hospital of University of Southern CaliforniaLos AngelesCalifornia90033
Marie Grimes
[email protected]
323-442-8500
Jacquelyn Paige, MSN, RN
[email protected]
323-865-1545

Find similar trials in Los Angeles, CA

By research site
Keck Hospital of University of Southern California· Los Angeles, CA

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