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

Last updated: September 24, 2024
Sponsor: Vascutek Ltd.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Aneurysm

Vascular Diseases

Treatment

Cardiovascular Patch

Gelweave Vascular Graft

Gelweave Valsalva Vascular Graft

Clinical Study ID

NCT04545502
PANTHER-001
  • Ages > 18
  • All Genders

Study 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

Inclusion

Inclusion Criteria:

  • Patients must meet all of the following inclusion criteria in order to be eligiblefor 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 informedconsent 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 ECregulations relating to consent process should be followed.

Retrospective Patients only:

  • Patient has a minimum of 1 year post-operative follow-up data available, or completedata to death.

  • Patient implant date is no more than 5 years prior to study start date.

Exclusion

Exclusion Criteria:

  • Any patient who meets any of the following exclusion criteria will be excluded fromparticipation in the study:

  • Patient is unable or unwilling to comply with the SOC procedures or follow-upregime

  • Patient is contraindicated per the device IFU

  • Patient has any other medical, social or psychological problems that in theopinion of the investigator preclude them from receiving this treatment and theprocedures and evaluations pre- and post-procedure

Study Design

Total Participants: 2000
Treatment Group(s): 5
Primary Treatment: Cardiovascular Patch
Phase:
Study Start date:
February 17, 2021
Estimated Completion Date:
January 31, 2033

Connect with a study center

  • UZ Gent

    Gent, 9000
    Belgium

    Active - Recruiting

  • AZ Groeninge Kortrijk

    Kortrijk, 8500
    Belgium

    Active - Recruiting

  • UZ Leuven

    Leuven, 3000
    Belgium

    Active - Recruiting

  • Hamilton General

    Hamilton, Ontario L8L 2X2
    Canada

    Site Not Available

  • CHU Bordeaux

    Bordeaux,
    France

    Site Not Available

  • CHU Clermont Ferrand

    Clermont-Ferrand,
    France

    Active - Recruiting

  • CHU de Dijon

    Dijon,
    France

    Active - Recruiting

  • CHU de Lille

    Lille, 59000
    France

    Active - Recruiting

  • Hôpital Nord Marseille

    Marseille, 13015
    France

    Active - Recruiting

  • CHU de Rennes

    Rennes, 35033
    France

    Site Not Available

  • Hôpitaux Universitaires de Strasbourg - Hôpital Civil

    Strasbourg, 67091
    France

    Active - Recruiting

  • CHU de Toulouse - Hôpital Rangueil

    Toulouse, 31059
    France

    Active - Recruiting

  • Charité Berlin

    Berlin, 12200
    Germany

    Active - Recruiting

  • Uniklinik Bonn

    Bonn, 53127
    Germany

    Active - Recruiting

  • UNIVERSITÄTSKLINIKUM FREIBURG/Bad Krozingen

    Freiburg,
    Germany

    Active - Recruiting

  • UKE Hamburg

    Hamburg, 20251
    Germany

    Active - Recruiting

  • Heart Center Leipzig

    Leipzig,
    Germany

    Active - Recruiting

  • Universitätsmedizin Mainz (University Hospital Mainz)

    Mainz, 55131
    Germany

    Active - Recruiting

  • Ludwig-Maximilian Universität (LMU) Klinikum

    Munich, 81377
    Germany

    Active - Recruiting

  • Semmelweis University Heart and Vascular Center

    Budapest, 1122
    Hungary

    Active - Recruiting

  • Amphia Hospital (Ziekenhuis) Breda

    Breda, 4818
    Netherlands

    Active - Recruiting

  • University of Colorado Anschutz

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • University of South Florida - Tampa General

    Tampa, Florida 33620
    United States

    Active - Recruiting

  • Indiana University Health

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • Duke University

    Durham, North Carolina 27705
    United States

    Active - Recruiting

  • East Carolina University

    Greenville, North Carolina 27858
    United States

    Active - Recruiting

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

  • Ohio State University

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • Lehigh Valley Hospital

    Allentown, Pennsylvania 18103
    United States

    Active - Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19105
    United States

    Active - Recruiting

  • Virginia Commonwealth University

    Richmond, Virginia 23298
    United States

    Active - Recruiting

  • University of Washington

    Seattle, Washington 98195
    United States

    Site Not Available

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