Status:

RECRUITING

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

Lead Sponsor:

JOTEC GmbH

Conditions:

Vascular Diseases

Eligibility:

All Genders

18+ years

Brief 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 a...

Detailed Description

In this study, patients who receive a Vascular Graft for the treatment of arterial diseases (aneurysm, PAU, IMH, dissection, stenosis) of the aorta or peripheral arteries (lower limbs) or as an AV shu...

Eligibility Criteria

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

Key Trial Info

Start Date :

December 6 2021

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

March 30 2030

Estimated Enrollment :

500 Patients enrolled

Trial Details

Trial ID

NCT05145517

Start Date

December 6 2021

End Date

March 30 2030

Last Update

May 19 2022

Active Locations (1)

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1

Universitätsklinikum Münster

Münster, North Rhine-Westphalia, Germany, 48149

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