Actively Recruiting
A Post-Market Clinical Follow-up Study in Patients Treated With Vascular Grafts
Led by JOTEC GmbH · Updated on 2022-05-19
500
Participants Needed
1
Research Sites
433 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Post-Market Clinical Follow-up Study in Patients Treated With Vascular Grafts
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is 18 years or older at time of written informed consent
- Patient was selected for treatment with a commercially available JOTEC Vascular Graft
- Patient has at least one of the following: acute (up to 14 days) or subacute (15-90 days) dissection with double lumina in the aorta or peripheral arteries (lower limb), chronic (>90 days) dissection with double lumina in the aorta or peripheral arteries (lower limb), aneurysm in the aorta or peripheral arteries (lower limb), intramural hematoma in the aorta or peripheral arteries (lower limb), penetrating aortic ulcer in the aorta or peripheral arteries (lower limb), contained rupture in the aorta or peripheral arteries (lower limb), stenosis in the aorta or peripheral arteries (lower limb), debranching of head vessels, arterious-venous shunt
- Patient is willing and able to comply with all clinical study procedures and visits
- Patient has given written informed consent to participate in the study
You will not qualify if you...
- Patient has any medical, social, or psychological problem that prevents them from receiving treatment or completing study evaluations, as judged by the investigator
- Patient is scheduled for reconstruction of the tibial artery
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, Germany, 48149
Actively Recruiting
Research Team
H
Heike Fischer, Dr.
CONTACT
A
Alexander Oberhuber, Prof. Dr.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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