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Clinical Trials in Germany / NCT05145517
Recruiting Observational

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

NCT05145517 · tracked via the Priya Life Science Germany tracker
Sponsor
Phase
Observational
Started
2021-12-06
Last updated
2022-05-19

Condition(s) studied

Vascular Diseases

Investigational drug(s) / intervention(s)

Open repair

Open repair: Open repair of the aorta and peripheral arteries

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Universitätsklinikum Münster Münster North Rhine-Westphalia Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05145517 on ClinicalTrials.gov ↗ ← All trials in Germany