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

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.

Conditions

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

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

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

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

Condition
Aneurysm
Intervention / Treatment

-

Contacts and Locations

Aurora

University of Colorado Anschutz, Aurora, Colorado, United States, 80045

Tampa

University of South Florida - Tampa General, Tampa, Florida, United States, 33620

Indianapolis

Indiana University Health, Indianapolis, Indiana, United States, 46202

Durham

Duke University, Durham, North Carolina, United States, 27705

Greenville

East Carolina University, Greenville, North Carolina, United States, 27858

Cleveland

University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States, 44106

Columbus

Ohio State University, Columbus, Ohio, United States, 43210

Allentown

Lehigh Valley Hospital, Allentown, Pennsylvania, United States, 18103

Philadelphia

University of Pennsylvania, Philadelphia, Pennsylvania, United States, 19105

Richmond

Virginia Commonwealth University, Richmond, Virginia, United States, 23298

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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Vascutek Ltd.,

Study Record Dates

2033-01