A Post-Market Clinical Follow-up Study in Patients Treated With Vascular Grafts
FLOWGRAFT - A Post-Market Clinical Follow-up Study in Patients Treated With Vascular Grafts
JOTEC GmbH
500 participants
Dec 6, 2021
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria14
- Patient ≥ 18 years at time of written informed consent
- Patient was selected for treatment with a commercially available Vascular Graft of JOTEC
- Patient satisfies at least one of the following categories:
- Acute (14 days) / subacute (15 - 90 days) dissection with double lumina in the aorta or peripheral artery / arteries (lower limb)
- Chronic (>90 days) dissection with double lumina in the aorta or peripheral artery / arteries (lower limb)
- Aneurysm in the aorta or peripheral artery / arteries (lower limb)
- IMH in the aorta or peripheral artery / arteries (lower limb)
- PAU in the aorta or peripheral artery / arteries (lower limb)
- Contained rupture in the aorta or peripheral artery / arteries (lower limb)
- Stenosis in the aorta or peripheral artery / arteries (lower limb)
- Debranching of head vessels
- AV shunt
- Patient is willing and able to comply with all clinical study procedures and study visits.
- Patient has given written informed consent to participate in the study.
Exclusion Criteria2
- Patient has any other medical, social, or psychological problem that in the opinion of the investigator preclude them from receiving this treatment, procedures, and evaluations pre- and post-procedure.
- Patient is scheduled for reconstruction of the tibial artery
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Interventions
Open repair of the aorta and peripheral arteries
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05145517