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RECRUITING
NCT05145517

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

Sponsor: JOTEC GmbH

View on ClinicalTrials.gov

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.

Official title: FLOWGRAFT - A Post-Market Clinical Follow-up Study in Patients Treated With Vascular Grafts

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

500

Start Date

2021-12-06

Completion Date

2030-03-30

Last Updated

2022-05-19

Healthy Volunteers

No

Interventions

DEVICE

Open repair

Open repair of the aorta and peripheral arteries

Locations (1)

Universitätsklinikum Münster

Münster, North Rhine-Westphalia, Germany