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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date April 2024
Source Vascutek Ltd.
Contact Clinical Study Manager
Phone +44 141 343 0194
Email r.smith1@terumoaortic.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Intervention

Device:
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.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Vascutek Ltd.

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  France,  Germany,  Hungary,  Netherlands, 

Outcome

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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