RecruitingNCT04545502

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

Sponsor

Vascutek Ltd.

Enrollment

2,000 participants

Start Date

Feb 17, 2021

Study Type

OBSERVATIONAL

Conditions

Aneurysm Aortic Diseases Aortic Arch Aortic Root Aneurysm Dissection Aortic Root Dissection Carotid Artery Injuries Bypass Extremity Graft Occlusive Vascular Disease

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

The PANTHER study is a large real-world registry collecting long-term data on patients who receive Terumo Aortic vascular grafts and cardiovascular patches — medical devices made of synthetic material used to repair or replace diseased blood vessels, particularly the aorta (the body's main artery). These grafts and patches are used in surgeries to treat aneurysms (bulging arteries), arterial blockages, and other vascular conditions. The goal of the study is to build a comprehensive safety and efficacy database documenting how these devices perform in real-world clinical practice over many years. Both prospective (newly implanted) and retrospective (already implanted) patients are included. No experimental intervention is performed — all patients receive standard surgical treatment. You may be eligible if: - You are of the minimum age required by your local regulations - You require treatment with one of the Terumo Aortic vascular grafts or patches - You are willing to comply with standard follow-up visits - You or your representative has given informed consent You may NOT be eligible if: - You are unable or unwilling to comply with follow-up procedures - The device is contraindicated for your specific condition - You have medical, social, or psychological issues that the investigator determines preclude safe participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEGelsoft Plus Vascular Graft

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

DEVICEVascular 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.

DEVICECardiovascular Patch

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

DEVICEGelweave 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.

DEVICEGelweave 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.

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

UZ Gent

Ghent, Belgium

AZ Groeninge Kortrijk

Kortrijk, Belgium

UZ Leuven

Leuven, Belgium

Hamilton General

Hamilton, Ontario, Canada

CHU Bordeaux

Bordeaux, France

CHU Clermont Ferrand

Clermont-Ferrand, France

CHU de Dijon

Dijon, France

CHU de Lille

Lille, France

Hôpital Nord Marseille

Marseille, France

CHU de Rennes

Rennes, France

Hôpitaux Universitaires de Strasbourg - Hôpital Civil

Strasbourg, France

CHU de Toulouse - Hôpital Rangueil

Toulouse, France

Charité Berlin

Berlin, Germany

Uniklinik Bonn

Bonn, Germany

UNIVERSITÄTSKLINIKUM FREIBURG/Bad Krozingen

Freiburg im Breisgau, Germany

UKE Hamburg

Hamburg, Germany

Heart Center Leipzig

Leipzig, Germany

Universitätsmedizin Mainz (University Hospital Mainz)

Mainz, Germany

Ludwig-Maximilian Universität (LMU) Klinikum

Munich, Germany

Semmelweis University Heart and Vascular Center

Budapest, Budapest, Hungary

Amphia Hospital (Ziekenhuis) Breda

Breda, Netherlands

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NCT04545502

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