Actively Recruiting
FLOWGRAFT Post-Market Clinical Follow-up Study in Patients Treated With Vascular Grafts for Arterial Diseases
Led by JOTEC GmbH · Updated on 2022-05-19
500
Participants Needed
1
Research Sites
286 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research investigates the safety and performance of various Vascular Grafts, including FlowWeave Bioseal, FlowNit Bioseal, FlowLine Bipore, and FlowLine Bipore Heparin, in treating arterial diseases such as dissection, aneurysm, intramural hematoma, penetrating aortic ulcer, contained rupture, and stenosis affecting the aorta or peripheral arteries in the lower limbs. It also covers the use of these grafts for debranching head vessels and as arterio-venous shunts. The study is observational and focuses on patients who have already received these grafts. Patients included in this study have received one of these Vascular Grafts as part of their treatment for arterial conditions. The study collects data from routine care, including interventions like open repair of the aorta and peripheral arteries. The data collection period lasts approximately 60 months plus an additional 6 months beyond the last follow-up visit, depending on each patient's timeline. Participants' medical records and observations gathered during standard care visits will be used for data collection. Researchers will monitor outcomes such as 30-day mortality, longer-term mortality at intervals up to 60 months, graft-related adverse events, hemorrhage, stenosis or occlusion, graft patency, pseudoaneurysm formation, infections, sepsis, and stroke occurrences. Patients will be observed throughout this period while continuing their usual care, providing a comprehensive view of graft performance and safety over time.
CONDITIONS
Brief Title
A Post-Market Clinical Follow-up Study in Patients Treated With Vascular Grafts
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is 18 years of age or older at the time of written informed consent
- Patient was selected for treatment with a commercially available Vascular Graft of JOTEC
- Patient has one or more of the following: acute or subacute dissection with double lumina in the aorta or peripheral arteries, chronic dissection, aneurysm, intramural hematoma, penetrating aortic ulcer, contained rupture, stenosis in aorta or peripheral arteries, debranching of head vessels, or arterio-venous 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
You will not qualify if you...
- Patient has any other medical, social, or psychological problem that, in the opinion of the investigator, prevents them from receiving the treatment and participating in study procedures
- Patient is scheduled for reconstruction of the tibial artery
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 60 months from the date of intervention
Participants who receive a vascular graft as part of routine care are observed.
Follow-up visits up to 60 months depending on the date of last follow-up
Duration - Up to an additional 6 months after the main observation period
Participants are monitored for vascular graft-related outcomes and adverse events through routine clinical follow-up.
Visits occur as part of routine care follow-up
Trial Site Locations
Total: 1 location
1
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, Germany, 48149
Actively Recruiting
Research Team
H
Heike Fischer, Dr.
A
Alexander Oberhuber, Prof. Dr.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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