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NCT04545502Recruiting

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

Vascutek Ltd.

Start Date

2/17/2021

Completion Date

1/1/2037

Summary

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DEVICE

Gelsoft Plus Vascular Graft

DEVICE

Vascular Bypass Graft

DEVICE

Cardiovascular Patch

DEVICE

Gelweave Vascular Graft

DEVICE

Gelweave Valsalva Vascular Graft

Interested in This Trial?

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Conditions

AneurysmDissectionAortic Root AneurysmAortic Root DissectionCarotid Artery InjuriesAortic ArchBypass Extremity GraftOcclusive Vascular DiseaseAortic Diseases

Locations

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

UZ Gent

Ghent, 9000

Belgium

AZ Groeninge Kortrijk

Kortrijk, 8500

Belgium

UZ Leuven

Leuven, 3000

Belgium

Hamilton General

Hamilton, Ontario L8L 2X2

Canada

CHU Bordeaux

Bordeaux,

France

CHU Clermont Ferrand

Clermont-Ferrand,

France

CHU de Dijon

Dijon,

France

CHU de Lille

Lille, 59000

France

Hôpital Nord Marseille

Marseille, 13015

France

CHU de Rennes

Rennes, 35033

France

Hôpitaux Universitaires de Strasbourg - Hôpital Civil

Strasbourg, 67091

France

CHU de Toulouse - Hôpital Rangueil

Toulouse, 31059

France

Charité Berlin

Berlin, 12200

Germany

Uniklinik Bonn

Bonn, 53127

Germany

UNIVERSITÄTSKLINIKUM FREIBURG/Bad Krozingen

Freiburg im Breisgau,

Germany

UKE Hamburg

Hamburg, 20251

Germany

Heart Center Leipzig

Leipzig,

Germany

Universitätsmedizin Mainz (University Hospital Mainz)

Mainz, 55131

Germany

Ludwig-Maximilian Universität (LMU) Klinikum

Munich, 81377

Germany

Semmelweis University Heart and Vascular Center

Budapest, Budapest 1122

Hungary

Amphia Hospital (Ziekenhuis) Breda

Breda, 4818

Netherlands