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

  • STATUS
    Recruiting
  • End date
    Mar 30, 2030
  • participants needed
    500
  • sponsor
    JOTEC GmbH
Updated on 4 June 2022
stenosis
aneurysm

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.

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.

Details
Condition Vascular Diseases
Treatment open repair
Clinical Study IdentifierNCT05145517
SponsorJOTEC GmbH
Last Modified on4 June 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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