RECRUITING

Frailty and Physician Modified Fenestrated Endograft for Thoracoabdominal Aortic Pathologies

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2021-02-23
Study Completion:2032-07-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04524247

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. 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.
  3. 2. Aneurysm with a history of growth ≥ 0.5cm per year.
  4. 3. Saccular aneurysms deemed at significant risk for rupture based on physician interpretation.
  5. 4. Symptomatic aneurysm without hemodynamic instability
  6. 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.
  1. * Patients must be excluded from the study if any of the following conditions is true:
  2. 1. Less than 18 years of age.
  3. 2. Unwilling to comply with the follow-up schedule.
  4. 3. Inability or refusal to give informed consent by the patient or a legally authorized representative.
  5. 4. Pregnant or breastfeeding.
  6. 5. Life-expectancy less than 2 years.
  7. 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.
  8. 7. Eligible for treatment with FDA-approved marketed device.
  9. 8. Eligible and willing to travel to a center with IDE protocol wherein the device is made by a manufacturer.

Contacts and Locations

Study Contact

Katie O'Donnell, MPH
CONTACT
323-442-6835
Kathleen.O'Donnell@med.usc.edu
Jacquelyn Paige, MSN, RN
CONTACT
323-865-1545
Jacquelyn.Paige@med.usc.edu

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of Southern California

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-02-23
Study Completion Date2032-07-02

Study Record Updates

Study Start Date2021-02-23
Study Completion Date2032-07-02

Terms related to this study

Additional Relevant MeSH Terms

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