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RECRUITING

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

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

NCT04545502•Vascutek Ltd.

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

•* 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

Locations (31)

University of Colorado Anschutz

Aurora, Colorado, United States

University of South Florida - Tampa General

Tampa, Florida, United States

Indiana University Health

Indianapolis, Indiana, United States

Duke University

Durham, North Carolina, United States

East Carolina University

Greenville, North Carolina, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Ohio State University

Columbus, Ohio, United States

Lehigh Valley Hospital

Allentown, Pennsylvania, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Key Dates

Start Date

February 17, 2021

Primary Completion Date

December 1, 2026

Completion Date

January 1, 2037

Last Updated

June 3, 2025

Enrollment

2,000

ESTIMATED participants

Conditions

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

Interventions

Gelsoft Plus Vascular Graft

DEVICE

Vascular Bypass Graft

DEVICE

Cardiovascular Patch

DEVICE

Gelweave Vascular Graft

DEVICE

Gelweave Valsalva Vascular Graft

DEVICE

Contacts

Clinical Study Manager

CONTACT

+44 141 343 0194 r.smith1@terumoaortic.com

TA UK Clinical Research

CONTACT

+44 141 812 5555 clinicalresearchuk@terumoaortic.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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