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A Post-Market Clinical Follow-up Study in Patients Treated With Vascular Grafts

Recruitingn/aAges 18 Years - anyAllJOTEC GmbH
NCT05145517 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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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What it tests

  • Open repair
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Where

1 site
Universitätsklinikum Münster
Münster, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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