RECRUITING

PANTHER Study of Terumo Aortic Knitted and Woven Grafts, and Cardiovascular Patches

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 purpose of this registry is to collect safety and performance data on all commercially available Terumo Aortic knitted and woven grafts, and cardiovascular patches in standard clinical practice. Data will be collected both retrospectively and prospectively.

Official Title

A Prospective and Retrospective, Multi-Centre, Post-Market, Non-Interventional Study of Terumo Aortic Knitted and Woven Grafts, and Cardiovascular Patches

Quick Facts

Study Start:2021-02-17
Study Completion:2033-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04545502

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 must meet all of the following inclusion criteria in order to be eligible for inclusion in the study:
  2. * Patient meets the minimum age as per local regulations at time of consent
  3. * Patient requires treatment with study device(s) according to the IFU(s)
  4. * Patient is willing and able to comply with all SOC procedures and study visits
  5. * Patient or their legally authorised representative (LAR) has given written informed consent to participate in study, including consent to collect data retrospectively
  6. * For prospective emergency patients, retrospective consent is permissible
  7. * For retrospective patients who are deceased at time of enrollment, local EC regulations relating to consent process should be followed.
  8. * Patient has a minimum of 1 year post-operative follow-up data available, or complete data to death.
  9. * Patient implant date is no more than 5 years prior to study start date.
  1. * Any patient who meets any of the following exclusion criteria will be excluded from participation in the study:
  2. * Patient is unable or unwilling to comply with the SOC procedures or follow-up regime
  3. * Patient is contraindicated per the device IFU
  4. * Patient has any other medical, social or psychological problems that in the opinion of the investigator preclude them from receiving this treatment and the procedures and evaluations pre- and post-procedure

Contacts and Locations

Study Contact

Clinical Study Manager
CONTACT
+44 141 343 0194
r.smith1@terumoaortic.com
TA UK Clinical Research
CONTACT
+44 141 812 5555
clinicalresearchuk@terumoaortic.com

Study Locations (Sites)

University of Colorado Anschutz
Aurora, Colorado, 80045
United States
University of South Florida - Tampa General
Tampa, Florida, 33620
United States
Indiana University Health
Indianapolis, Indiana, 46202
United States
Duke University
Durham, North Carolina, 27705
United States
East Carolina University
Greenville, North Carolina, 27858
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
United States
Ohio State University
Columbus, Ohio, 43210
United States
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19105
United States
Virginia Commonwealth University
Richmond, Virginia, 23298
United States

Collaborators and Investigators

Sponsor: Vascutek Ltd.

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 Date2021-02-17
Study Completion Date2033-01

Study Record Updates

Study Start Date2021-02-17
Study Completion Date2033-01

Terms related to this study

Keywords Provided by Researchers

  • Vascular Surgery

Additional Relevant MeSH Terms

  • Aneurysm
  • Dissection
  • Aortic Root Aneurysm
  • Aortic Root Dissection
  • Carotid Artery Injuries
  • Aortic Arch
  • Bypass Extremity Graft
  • Occlusive Vascular Disease
  • Aortic Diseases