A Post-Market Clinical Follow-up Study in Patients Treated With Vascular Grafts
ConditionVascular Diseases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJOTEC GmbH
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient ≥ 18 years at time of written informed consent
Patient was selected for treatment with a commercially available Vascular Graft of JOTEC
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)
Disqualifiers
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
Trial population
Male and female patients with arterial disease who are scheduled to be treated with a Vascular Graft according to the instructions for use and their physician's discretion in accordance with the inclusion and exclusion criteria.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Open repair
DeviceOpen repair of the aorta and peripheral arteries
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Mortality
Rate of in-hospital all-cause mortality
Time frame
30-daySecondary outcomes
1
All-cause mortality
Rate of all-cause mortality
Time frame
30-day, 6-month,12-month, 24-month, 36-month, 60-month2
Vascular Graft-related adverse event
Rate of patients with Vascular Graft-related adverse event
Time frame
30-day, 6-month,12-month, 24-month, 36-month, 60-month3
Freedom from Vascular Graft -related hemorrhage
Rate of patients with freedom from Vascular Graft -related hemorrhage
Time frame
6-month,12-month, 24-month, 36-month, 60-month4
Vascular Graft stenosis > 50% or occlusion
Rate of patients with Vascular Graft stenosis \> 50% or occlusion
Time frame
6-month,12-month, 24-month, 36-month, 60-month Source ClinicalTrials.gov