Universitätsklinikum Münster
Münster, North Rhine-Westphalia, 48149, Germany
Location status: Recruiting
NCT Number: NCT05145517
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Münster, North Rhine-Westphalia, 48149, Germany
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Open repair of the aorta and peripheral arteries
Other names: Open repair of the aorta and peripheral arteries
Time frame: 30-day
Rate of in-hospital all-cause mortality
Time frame: 30-day, 6-month,12-month, 24-month, 36-month, 60-month
Rate of all-cause mortality
Time frame: 30-day, 6-month,12-month, 24-month, 36-month, 60-month
Rate of patients with Vascular Graft-related adverse event
Time frame: 6-month,12-month, 24-month, 36-month, 60-month
Rate of patients with freedom from Vascular Graft -related hemorrhage
Time frame: 6-month,12-month, 24-month, 36-month, 60-month
Rate of patients with Vascular Graft stenosis > 50% or occlusion
Time frame: 6-month,12-month, 24-month, 36-month, 60-month
Rate of patients with Vascular Graft primary patency
Time frame: 6-month,12-month, 24-month, 36-month, 60-month
Rate of patients with Vascular Graft secondary patency (after reintervention)
Time frame: 6-month,12-month, 24-month, 36-month, 60-month
Rate of patients with pseudoaneurysm at the sutures or in the Vascular Graft
Time frame: 6-month,12-month, 24-month, 36-month, 60-month
Rate of patients with vascular Graft infection
Time frame: 6-month,12-month, 24-month, 36-month, 60-month
Rate of patients with new sepsis
Time frame: 6-month,12-month, 24-month, 36-month, 60-month
Rate of patients with new stroke
Contact information is provided by the study sponsor or research team.
Alexander Oberhuber, Prof. Dr.
CONTACT
Heike Fischer, Dr.
CONTACT
JOTEC GmbH
Industry
FLOWGRAFT - A Post-Market Clinical Follow-up Study in Patients Treated With Vascular Grafts
Acronym: FLOWGRAFT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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