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

NCT05145517 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2022-05-19

No results posted yet for this 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.

Conditions

  • Vascular Diseases

Interventions

DEVICE

Open repair

Open repair of the aorta and peripheral arteries

Sponsors & Collaborators

  • JOTEC GmbH

    lead INDUSTRY

Principal Investigators

  • Alexander Oberhuber, Prof. Dr. · University hospital Münster

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-06
Primary Completion
2024-10-01
Completion
2030-03-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05145517 on ClinicalTrials.gov