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โ† Trials
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PANTHER Study of Terumo Aortic Knitted and Woven Grafts, and Cardiovascular Patches

Recruitingn/aAges 18 Years - anyAllVascutek Ltd.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Gelsoft Plus Vascular Graft
  • Vascular Bypass Graft
  • Cardiovascular Patch
  • Gelweave Vascular Graft
  • Gelweave Valsalva Vascular Graft
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Where

30 sites
University of Colorado Anschutz
Aurora, United States
University of South Florida - Tampa General
Tampa, United States
Indiana University Health
Indianapolis, United States
Duke University
Durham, United States
East Carolina University
Greenville, United States
University Hospitals Cleveland Medical Center
Cleveland, United States
Ohio State University
Columbus, United States
Lehigh Valley Hospital
Allentown, United States

โ€ฆand 22 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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