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.
Study Type
OBSERVATIONAL
Enrollment
2,000
Gelatin coated, knitted vascular prosthesis implanted to act as a conduit for channeling blood during repair of damaged or diseased vessels.
Gelatin coated, knitted vascular prosthesis implanted to act as an extra-anatomical bypass for channeling blood during repair of damaged or diseased vessels.
Cardiovascular knitted polyester patches are frequently used to treat the carotid or femoral arteries to prevent stroke and repair damage to vessels.
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.
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.
University of Colorado Anschutz
Aurora, Colorado, United States
RECRUITINGUniversity of South Florida - Tampa General
Tampa, Florida, United States
RECRUITINGIndiana University Health
Indianapolis, Indiana, United States
RECRUITINGDuke University
Durham, North Carolina, United States
Operative Death
30 Day or In-Hospital Mortality
Time frame: 1 Year
Graft Leakage
Device Failure: The presence of leakage or excessive bleeding through graft/patch
Time frame: 1 Year
Device Endpoints
Device failures, requirement for reintervention or device related adverse events
Time frame: 1 Year
Procedural Endpoints
Rifampicin or heparin soaking, procedure related adverse events
Time frame: 1 Year
Safety Endpoints
Occurrence of the following: Mortality, Ischemia, Occlusion, Thrombosis, Haemmorrhage, Rupture, Pseudoaneurysm, Stroke
Time frame: 1 Year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
East Carolina University
Greenville, North Carolina, United States
RECRUITINGUniversity Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
RECRUITINGOhio State University
Columbus, Ohio, United States
RECRUITINGLehigh Valley Hospital
Allentown, Pennsylvania, United States
RECRUITINGUniversity of Pennsylvania
Philadelphia, Pennsylvania, United States
RECRUITINGVirginia Commonwealth University
Richmond, Virginia, United States
RECRUITING...and 21 more locations