Gelsoft Plus Vascular Graft
DeviceGelatin coated, knitted vascular prosthesis implanted to act as a conduit for channeling blood during repair of damaged or diseased vessels.
Other names: Gelsoft Plus
NCT Number: NCT04545502
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
UZ Gent, Ghent, Belgium
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
All Patients:
Retrospective Patients only:
Exclusion criteria
Gelatin coated, knitted vascular prosthesis implanted to act as a conduit for channeling blood during repair of damaged or diseased vessels.
Other names: Gelsoft Plus
Gelatin coated, knitted vascular prosthesis implanted to act as an extra-anatomical bypass for channeling blood during repair of damaged or diseased vessels.
Other names: Gelsoft Plus Extra Anatomical
Cardiovascular knitted polyester patches are frequently used to treat the carotid or femoral arteries to prevent stroke and repair damage to vessels.
Other names: Gelseal Patch, Gelsoft Patch, Thinwall Patch, Cardiovascular Fabrics
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.
Other names: Gelweave
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.
Other names: Gelweave Valsalva
Time frame: 1 Year
30 Day or In-Hospital Mortality
Time frame: 1 Year
Device Failure: The presence of leakage or excessive bleeding through graft/patch
Time frame: 1 Year
Device failures, requirement for reintervention or device related adverse events
Time frame: 1 Year
Rifampicin or heparin soaking, procedure related adverse events
Time frame: 1 Year
Occurrence of the following: Mortality, Ischemia, Occlusion, Thrombosis, Haemmorrhage, Rupture, Pseudoaneurysm, Stroke
Contact information is provided by the study sponsor or research team.
Clinical Study Manager
CONTACT
TA UK Clinical Research
CONTACT
Vascutek Ltd.
Industry
A Prospective and Retrospective, Multi-Centre, Post-Market, Non-Interventional Study of Terumo Aortic Knitted and Woven Grafts, and Cardiovascular Patches
Acronym: PANTHER
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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