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

RecruitingObservational study

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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion Criteria:

* Patients must meet all of the following inclusion criteria in order to be eligible for inclusion in the study:

All Patients:

* 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.

Retrospective Patients only:

* 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.

Exclusion Criteria:

* 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

About the study

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.

What is being tested

Sponsor: Vascutek Ltd. · Participants: 2,000 · Started: Feb 17, 2021

Contact the study team

Official record on ClinicalTrials.gov — NCT04545502

Locations in the U.S.

ColoradoUniversity of Colorado Anschutz, Aurora
FloridaUniversity of South Florida - Tampa General, Tampa
IndianaIndiana University Health, Indianapolis
North CarolinaDuke University, Durham
East Carolina University, Greenville
OhioUniversity Hospitals Cleveland Medical Center, Cleveland
Ohio State University, Columbus
PennsylvaniaLehigh Valley Hospital, Allentown
University of Pennsylvania, Philadelphia
VirginiaVirginia Commonwealth University, Richmond

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.