Aneurysm Clinical Trial
— PANTHEROfficial title:
A Prospective and Retrospective, Multi-Centre, Post-Market, Non-Interventional Study of Terumo Aortic Knitted and Woven Grafts, and Cardiovascular Patches
NCT number | NCT04545502 |
Other study ID # | PANTHER-001 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | February 17, 2021 |
Est. completion date | January 2033 |
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.
Status | Recruiting |
Enrollment | 2000 |
Est. completion date | January 2033 |
Est. primary completion date | January 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | UZ Gent | Gent | |
Belgium | AZ Groeninge Kortrijk | Kortrijk | |
Belgium | UZ Leuven | Leuven | |
Canada | Hamilton General | Hamilton | Ontario |
France | 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 | |
Germany | Charité Berlin | Berlin | |
Germany | Uniklinik Bonn | Bonn | |
Germany | UNIVERSITÄTSKLINIKUM FREIBURG/Bad Krozingen | Freiburg | |
Germany | UKE Hamburg | Hamburg | |
Germany | Heart Center Leipzig | Leipzig | |
Germany | Universitätsmedizin Mainz (University Hospital Mainz) | Mainz | |
Germany | Ludwig-Maximilian Universität (LMU) Klinikum | Munich | |
Hungary | Semmelweis University Heart and Vascular Center | Budapest | |
Netherlands | Amphia Hospital (Ziekenhuis) Breda | Breda | |
United States | Lehigh Valley Hospital | Allentown | Pennsylvania |
United States | University of Colorado Anschutz | Aurora | Colorado |
United States | University Hospitals Cleveland Medical Center | Cleveland | Ohio |
United States | Ohio State University | Columbus | Ohio |
United States | Duke University | Durham | North Carolina |
United States | East Carolina University | Greenville | North Carolina |
United States | Indiana University Health | Indianapolis | Indiana |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
United States | Virginia Commonwealth University | Richmond | Virginia |
United States | University of South Florida - Tampa General | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
Vascutek Ltd. |
United States, Belgium, Canada, France, Germany, Hungary, Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Operative Death | 30 Day or In-Hospital Mortality | 1 Year | |
Primary | Graft Leakage | Device Failure: The presence of leakage or excessive bleeding through graft/patch | 1 Year | |
Secondary | Device Endpoints | Device failures, requirement for reintervention or device related adverse events | 1 Year | |
Secondary | Procedural Endpoints | Rifampicin or heparin soaking, procedure related adverse events | 1 Year | |
Secondary | Safety Endpoints | Occurrence of the following: Mortality, Ischemia, Occlusion, Thrombosis, Haemmorrhage, Rupture, Pseudoaneurysm, Stroke | 1 Year |
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