Recruiting

Fenestrated Stent Grafts

Sponsor:

University of Southern California

Code:

NCT04524247

Conditions

Thoracoabdominal Aortic Aneurysm

Thoracoabdominal; Aortic, Aneurysm, Dissecting

Pararenal Aneurysm

Frailty Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Physician Modified Endografts

Study Details

Brief summary:

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.

Conditions

Thoracoabdominal Aortic Aneurysm

Thoracoabdominal; Aortic, Aneurysm, Dissecting

Pararenal Aneurysm

Frailty Syndrome

Study ID

NCT04524247

Start date

Feb 23, 2021

Status verified date

Jun, 2024

Completion date

Jul 2, 2032

Anticipated

Primary completion date

Jul 2, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients may be included in the study if the patient has at least one of the following indications and are anatomically appropriate for treatment with fenestrated/branched stent grafts.

1. Pararenal, paravisceral, and type I to IV thoracoabdominal aortic aneurysms or chronic post-dissection aneurysms with a diameter 5cm or 2 times the normal aortic diameter.
2. Aneurysm with a history of growth ≥ 0.5cm per year.
3. Saccular aneurysms deemed at significant risk for rupture based on physician interpretation.
4. Symptomatic aneurysm without hemodynamic instability
5. Aneurysms meeting any of the above criteria 1\~4, above or below the previous endovascular and/or open aortic repairs. Previously placed aortic stent graft or open aortic grafts may serve as seal zones.

Exclusion Criteria:

  • Patients must be excluded from the study if any of the following conditions is true:

1. Less than 18 years of age.
2. Unwilling to comply with the follow-up schedule.
3. Inability or refusal to give informed consent by the patient or a legally authorized representative.
4. Pregnant or breastfeeding.
5. Life-expectancy less than 2 years.
6. Participation in another investigational clinical or device trial, with the exception of participation in another investigational endovascular stent-graft protocol and performed remotely from the fenestrated procedure (>30 days). Examples include remote (>30days) participation in a thoracic, or abdominal branch device trial.
7. Eligible for treatment with FDA-approved marketed device.
8. Eligible and willing to travel to a center with IDE protocol wherein the device is made by a manufacturer.

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Physician Modified Endografts

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

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 and Locations

Central contacts

Katie O'Donnell, MPH

323-442-6835Kathleen.O'Donnell@med.usc.edu

Jacquelyn Paige, MSN, RN

323-865-1545Jacquelyn.Paige@med.usc.edu

Locations

Keck Hospital of University of Southern California

Recruiting

Los Angeles, California, United States, 90033

Contacts

Marie Grimes

323-442-8500Marie.grimes@med.usc.edu

Jacquelyn Paige, MSN, RN

323-865-1545jacquelyn.paige@med.usc.edu

More Information

Sponsor

University of Southern California

Last update posted

Jul 1, 2024

Last verified

Jun, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Southern California on 2024-07-01.