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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Operative Death [Срок оценки: 1 Year]
• Graft Leakage [Срок оценки: 1 Year]

Вторичные конечные точки (3)

• Device Endpoints [Срок оценки: 1 Year]
• Procedural Endpoints [Срок оценки: 1 Year]
• Safety Endpoints [Срок оценки: 1 Year]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 10 центров

• University of Colorado Anschutz — Aurora
• University of South Florida - Tampa General — Tampa
• Indiana University Health — Indianapolis
• Duke University — Durham
• East Carolina University — Greenville
• University Hospitals Cleveland Medical Center — Cleveland
• Ohio State University — Columbus
• Lehigh Valley Hospital — Allentown
• … и ещё 2 центра

Франция · 8 центров

• CHU Bordeaux — Bordeaux
• CHU Clermont Ferrand — Clermont-Ferrand
• CHU de Dijon — Dijon
• CHU de Lille — Lille
• Hôpital Nord Marseille — Marseille
• CHU de Rennes — Rennes
• Hôpitaux Universitaires de Strasbourg - Hôpital Civil — Strasbourg
• CHU de Toulouse - Hôpital Rangueil — Toulouse

Германия · 7 центров

• Charité Berlin — Berlin
• Uniklinik Bonn — Bonn
• UNIVERSITÄTSKLINIKUM FREIBURG/Bad Krozingen — Freiburg im Breisgau
• UKE Hamburg — Hamburg
• Heart Center Leipzig — Leipzig
• Universitätsmedizin Mainz (University Hospital Mainz) — Mainz
• Ludwig-Maximilian Universität (LMU) Klinikum — Munich

Бельгия · 3 центра

• UZ Gent — Ghent
• AZ Groeninge Kortrijk — Kortrijk
• UZ Leuven — Leuven

Канада · 1 центр

• Hamilton General — Hamilton

Венгрия · 1 центр

• Semmelweis University Heart and Vascular Center — Budapest

Нидерланды · 1 центр

• Amphia Hospital (Ziekenhuis) Breda — Breda

Идентификаторы

NCT: NCT04545502 · PANTHER-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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