RECRUITING

Endovascular AAA Intervention Using the GORE® EXCLUDER® Conformable AAA Endoprosthesis or Iliac Branch Endoprosthesis

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Conditions

AAA - Abdominal Aortic AneurysmAneurysmAneurysm RepairEndovascularEVAREndoprosthesisAorticAortic Repair

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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

A prospective, observational post-market registry collecting outcomes through a 10-year post procedure follow-up for patients treated with the GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC Device) or the GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE Device) as a part of routine clinical practice.

Official Title

Assessment of Long Term, Endovascular AAA Intervention Using the GORE® EXCLUDER® Conformable AAA Endoprosthesis or Iliac Branch Endoprosthesis

Quick Facts

Study Start:2024-05-07
Study Completion:2042-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06218875

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. 1. Patient or legally authorized representative (LAR) provides written authorization and/or consent per institution and geographical requirements
  2. 2. Patient has been or is intended to be treated with an eligible registry device
  3. 3. Patient is age ≥ 18 years at time of informed consent signature.
  1. 1. Patient who is, at the time of consent, unlikely to be available for standard of care (SOC) follow-up visits as defined by the site's guidelines and procedures.
  2. 2. Patient with exclusion criteria required by local law.
  3. 3. Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study within 12 months of Together Registry enrollment. Subjects cannot be enrolled in another Together Registry module protocol.

Contacts and Locations

Study Contact

K Martin
CONTACT
928-864-2223
kgmartin@wlgore.com
E Ramirez
CONTACT
928-864-4646

Principal Investigator

S. Han
PRINCIPAL_INVESTIGATOR
University of Southern California

Study Locations (Sites)

St. Vincent Medical Group, Inc.
Indianapolis, Indiana, 46260
United States
McLaren Heatlh Care Corporation
Bay City, Michigan, 48708
United States
Mission Hospital
Asheville, North Carolina, 28801
United States
Columbia Medical Center of Plano
Plano, Texas, 75075
United States

Collaborators and Investigators

Sponsor: W.L.Gore & Associates

  • S. Han, 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 Date2024-05-07
Study Completion Date2042-09-30

Study Record Updates

Study Start Date2024-05-07
Study Completion Date2042-09-30

Terms related to this study

Keywords Provided by Researchers

  • Aneurysm
  • Aneurysm Repair
  • Endovascular
  • EVAR
  • Endoprosthesis
  • Aortic
  • Aortic Repair

Additional Relevant MeSH Terms

  • AAA - Abdominal Aortic Aneurysm