A Prospective and Retrospective, Multi-Centre, Post-Market, Non-Interventional Study of Terumo Aortic Knitted and Woven Grafts, and Cardiovascular Patches
Status: Recruiting
Location: See all (31) locations...
Intervention Type: Device
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Colorado
University of Colorado Anschutz
RECRUITING
Aurora
Florida
University of South Florida - Tampa General
RECRUITING
Tampa
Indiana
Indiana University Health
RECRUITING
Indianapolis
North Carolina
Duke University
RECRUITING
Durham
East Carolina University
RECRUITING
Greenville
Ohio
University Hospitals Cleveland Medical Center
RECRUITING
Cleveland
Ohio State University
RECRUITING
Columbus
Pennsylvania
Lehigh Valley Hospital
RECRUITING
Allentown
University of Pennsylvania
RECRUITING
Philadelphia
Virginia
Virginia Commonwealth University
RECRUITING
Richmond
Other Locations
Belgium
UZ Gent
RECRUITING
Ghent
AZ Groeninge Kortrijk
RECRUITING
Kortrijk
UZ Leuven
RECRUITING
Leuven
Canada
Hamilton General
NOT_YET_RECRUITING
Hamilton
France
CHU Bordeaux
WITHDRAWN
Bordeaux
CHU Clermont Ferrand
RECRUITING
Clermont-ferrand
CHU de Dijon
RECRUITING
Dijon
CHU de Lille
RECRUITING
Lille
Hôpital Nord Marseille
RECRUITING
Marseille
CHU de Rennes
WITHDRAWN
Rennes
Hôpitaux Universitaires de Strasbourg - Hôpital Civil
Patients with aneurysmal or occlusive disease, including those with connective tissue disorders who have received/will receive a Gelsoft Plus Straight or Bifurcate, implanted in the abdomen or peripheral arteries in the last 5 years and from study launch onwards.
Gelsoft Plus - Extra-Anatomical
Any patients who have received/will receive a Gelsoft Plus Extra-Anatomical supported or unsupported graft, implanted for: axillary-femoral bypass, femoral-femoral bypass or femoral-popliteal bypass in the last 5 years and from study launch onwards.
Patients who have been implanted with/require a cardiovascular patch for: thoracic vessel repair with a Gelseal Cardiovascular Patch; abdominal or peripheral vessel repair with a Gelsoft Cardiovascular Patch; or carotid endarterectomy with a Thin Wall Carotid Patch in the last 5 years and from study launch onwards.
Gelweave - Abdominal, Thoracic, Thoracoabdominal
Patients who, due to either aneurysmal or occlusive disease, have had/require vascular repair of one of the following, implanted in the last 5 years and from study launch onwards:~* Abdominal aorta, arteries arising from the abdominal aorta or peripheral arteries including femoral, iliac and popliteal arteries.~* Thoracic aorta or arteries arising from the thoracic aorta.~* Abdominal and thoracic aorta requiring a thoracoabdominal repair
Gelweave - Valsalva
Patients who have had/require aortic root repair using valve sparing or valve replacing procedures, with or without replacement of the aortic arch, implanted in the last 5 years and from study launch onwards.