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

NCT04545502 · tracked via the Priya Life Science USA tracker

Sponsor

Vascutek Ltd.

Phase

Observational

Started

2021-02-17

Last updated

2026-08-20

Condition(s) studied

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

Investigational drug(s) / intervention(s)

Gelsoft Plus Vascular GraftVascular Bypass GraftCardiovascular PatchGelweave Vascular GraftGelweave Valsalva Vascular Graft

Gelsoft Plus Vascular Graft: Gelatin coated, knitted vascular prosthesis implanted to act as a conduit for channeling blood during repair of damaged or diseased vessels.

Vascular Bypass Graft: Gelatin coated, knitted vascular prosthesis implanted to act as an extra-anatomical bypass for channeling blood during repair of damaged or diseased vessels.

Cardiovascular Patch: Cardiovascular knitted polyester patches are frequently used to treat the carotid or femoral arteries to prevent stroke and repair damage to vessels.

Gelweave Vascular Graft: The Gelweave woven polyester vascular graft allows replacement of large sections of arteries and, following anastomosis to the native blood vessel, provides a stable conduit for blood flow.

Gelweave Valsalva Vascular Graft: This woven polyester graft is designed to match the aortic root anatomy and is implanted to repair or replace a portion of the aorta in case of an aneurysm, dissection or coarctation at the level of the thoracic aorta.

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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Operative Death — 1 Year
30 Day or In-Hospital Mortality
Graft Leakage — 1 Year
Device Failure: The presence of leakage or excessive bleeding through graft/patch

Trial sites (30)

Facility	City	Region	Status
University of Colorado Anschutz	Aurora	Colorado	Recruiting
University of South Florida - Tampa General	Tampa	Florida	Recruiting
Indiana University Health	Indianapolis	Indiana	Recruiting
Duke University	Durham	North Carolina	Recruiting
East Carolina University	Greenville	North Carolina	Recruiting
University Hospitals Cleveland Medical Center	Cleveland	Ohio	Recruiting
Ohio State University	Columbus	Ohio	Recruiting
Lehigh Valley Hospital	Allentown	Pennsylvania	Recruiting
University of Pennsylvania	Philadelphia	Pennsylvania	Recruiting
Virginia Commonwealth University	Richmond	Virginia	Recruiting
UZ Gent	Ghent	Belgium	Recruiting
AZ Groeninge Kortrijk	Kortrijk	Belgium	Recruiting
UZ Leuven	Leuven	Belgium	Recruiting
CHU Bordeaux	Bordeaux	France	Withdrawn
CHU Clermont Ferrand	Clermont-Ferrand	France	Recruiting
CHU de Dijon	Dijon	France	Recruiting
CHU de Lille	Lille	France	Recruiting
Hôpital Nord Marseille	Marseille	France	Recruiting
CHU de Rennes	Rennes	France	Withdrawn
Hôpitaux Universitaires de Strasbourg - Hôpital Civil	Strasbourg	France	Recruiting
CHU de Toulouse - Hôpital Rangueil	Toulouse	France	Recruiting
Charité Berlin	Berlin	Germany	Recruiting
Uniklinik Bonn	Bonn	Germany	Recruiting
UNIVERSITÄTSKLINIKUM FREIBURG/Bad Krozingen	Freiburg im Breisgau	Germany	Recruiting
UKE Hamburg	Hamburg	Germany	Recruiting
Heart Center Leipzig	Leipzig	Germany	Recruiting
Universitätsmedizin Mainz (University Hospital Mainz)	Mainz	Germany	Recruiting
Ludwig-Maximilian Universität (LMU) Klinikum	Munich	Germany	Recruiting
Semmelweis University Heart and Vascular Center	Budapest	Budapest	Completed
Amphia Hospital (Ziekenhuis) Breda	Breda	Netherlands	Active Not Recruiting

More Vascutek Ltd. trials in the USA

Terumo Aortic Global Endovascular Registry Recruiting

A Study to Evaluate the Safety and Effectiveness of the Rapidlink Device When Used in Patients Undergoing an Open Surgical Procedure to Repair the Aorta Recruiting

Thoraflex Hybrid and Relay Extension Post-Approval Study Active, not recruiting

Other trials for the same condition

Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR Recruiting

An Observational Study On TheAccuracy Of Whole-Body Magnetic Resonance Imaging (Wb-Mri) ScreeningTo Predict Clinically Significant Diagnoses In General Population Subjects Interested In Proactive And Advanced General Preventive Healthcare. Recruiting

Safety and Efficacy of Endovascular Treatment of Intracranial Aneurysms With Surpass Elite With GUARDian Flow Diverter (GUARD) Recruiting

Long-term Characterization of GORE® TAG® Conformable Thoracic Stent Graft With ACTIVE CONTROL System Performance Recruiting

Intervascular Post-Market Clinical Follow-Up (PMCF) Registry Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04545502 on ClinicalTrials.gov ↗ ← All trials in the USA