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A Post-Market Clinical Follow-up Study in Patients Treated With Vascular Grafts
Sponsor: JOTEC GmbH
Summary
The FLOWGRAFT post-market clinical follow-up study is undertaken to show the safety and performance of FlowWeave Bioseal, FlowNit Bioseal, FlowLine Bipore and FlowLine Bipore Heparin (combined named as Vascular Grafts) in the treatment of arterial diseases, such as dissection, aneurysm, intramural hematoma (IMH), penetrating aortic ulcer (PAU), contained rupture, stenosis in the aorta or peripheral arteries (lower limbs). This includes the use of FlowWeave Bioseal or FlowNit Bioseal for debranching of the head vessels in an alone standing procedure. Furthermore, it includes the use of the FlowLine Bipore and FlowLine Bipore Heparin Grafts as arterious-venous (AV) shunt.
Official title: FLOWGRAFT - A Post-Market Clinical Follow-up Study in Patients Treated With Vascular Grafts
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
500
Start Date
2021-12-06
Completion Date
2030-03-30
Last Updated
2022-05-19
Healthy Volunteers
No
Conditions
Interventions
Open repair
Open repair of the aorta and peripheral arteries
Locations (1)
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, Germany