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