Frailty and Physician Modified Fenestrated Endograft for Thoracoabdominal Aortic Pathologies

Description

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

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Study Overview

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Study Details

Study overview

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.

Impact of Frailty on Clinical Outcomes of Patients Treated for Thoracoabdominal and Complex Abdominal Aortic Aneurysms With Physician-Modified Fenestrated and Branched Stent Grafts

Frailty and Physician Modified Fenestrated Endograft for Thoracoabdominal Aortic Pathologies

Condition
Thoracoabdominal Aortic Aneurysm
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Keck Hospital of University of Southern California, Los Angeles, California, United States, 90033

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Southern California,

Sukgu M Han, MD, MS, PRINCIPAL_INVESTIGATOR, University of Southern California

Study Record Dates

2032-07-02