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NCT05145517 | Recruiting | Vascular Diseases

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

JOTEC GmbH

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 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.

Condition or disease

Vascular Diseases

Intervention/treatment

Open repair

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 shunt will be observed. This includes patients in whom the Vascular Grafts are used for debranching or reconstruction of the head vessels. Participating physicians will be asked to provide the observations, that were collected during routine care. Written informed consent, specifically allowing the use of clinical records for this observational study, will be obtained from every patient prior to data collection. The period of data collection will be approximately 60 + 6 months (depending on the date of the last follow-up visit) from the date of intervention for each patient.}}

Study Type : Observational
Estimated Enrollment : 500 participants
Official Title : FLOWGRAFT - A Post-Market Clinical Follow-up Study in Patients Treated With Vascular Grafts
Actual Study Start Date : December 6, 2021
Estimated Primary Completion Date : October 1, 2024
Estimated Study Completion Date : March 30, 2030

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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
A Post-Market Clinical Follow-up Study in Patients Treated With Vascular Grafts

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

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Locations

Recruiting

Germany, NRW

University Hospital Münster

Münster, NRW, Germany, 48149