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

Recruiting now

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

In brief

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.

Key facts

Study ID

NCT04545502

Run by

Vascutek Ltd.

People needed

2000

Starts

2021-02-17

Expected to finish

2037-01-01

Last updated by the study team

2025-06-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Amphia Hospital (Ziekenhuis) Breda — Breda, Netherlands (enrolling)
• University of South Florida - Tampa General — Tampa, Florida, United States (enrolling)
• Indiana University Health — Indianapolis, Indiana, United States (enrolling)
• Duke University — Durham, North Carolina, United States (enrolling)
• East Carolina University — Greenville, North Carolina, United States (enrolling)
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (enrolling)
• Ohio State University — Columbus, Ohio, United States (enrolling)
• Lehigh Valley Hospital — Allentown, Pennsylvania, United States (enrolling)
• University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
• Virginia Commonwealth University — Richmond, Virginia, United States (enrolling)
• UZ Gent — Ghent, Belgium (enrolling)
• AZ Groeninge Kortrijk — Kortrijk, Belgium (enrolling)
• UZ Leuven — Leuven, Belgium (enrolling)
• Heart Center Leipzig — Leipzig, Germany (enrolling)
• Universitätsmedizin Mainz (University Hospital Mainz) — Mainz, Germany (enrolling)
• Ludwig-Maximilian Universität (LMU) Klinikum — Munich, Germany (enrolling)
• University of Colorado Anschutz — Aurora, Colorado, United States (enrolling)
• CHU Clermont Ferrand — Clermont-Ferrand, France (enrolling)
• CHU de Dijon — Dijon, France (enrolling)
• CHU de Lille — Lille, France (enrolling)
• Hôpital Nord Marseille — Marseille, France (enrolling)
• Hôpitaux Universitaires de Strasbourg - Hôpital Civil — Strasbourg, France (enrolling)
• CHU de Toulouse - Hôpital Rangueil — Toulouse, France (enrolling)
• Charité Berlin — Berlin, Germany (enrolling)
• Uniklinik Bonn — Bonn, Germany (enrolling)

Full record on ClinicalTrials.gov

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