A Post-Market Clinical Follow-up Study in Patients Treated With Vascular Grafts
- Conditions
- Vascular Diseases
- Registration Number
- NCT05145517
- Lead Sponsor
- JOTEC GmbH
- 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 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.
- 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 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
-
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.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mortality 30-day Rate of in-hospital all-cause mortality
- Secondary Outcome Measures
Name Time Method Vascular Graft-related adverse event 30-day, 6-month,12-month, 24-month, 36-month, 60-month Rate of patients with Vascular Graft-related adverse event
Vascular Graft stenosis > 50% or occlusion 6-month,12-month, 24-month, 36-month, 60-month Rate of patients with Vascular Graft stenosis \> 50% or occlusion
Vascular Graft secondary patency (after reintervention) 6-month,12-month, 24-month, 36-month, 60-month Rate of patients with Vascular Graft secondary patency (after reintervention)
Freedom from Vascular Graft -related hemorrhage 6-month,12-month, 24-month, 36-month, 60-month Rate of patients with freedom from Vascular Graft -related hemorrhage
Vascular Graft primary patency 6-month,12-month, 24-month, 36-month, 60-month Rate of patients with Vascular Graft primary patency
New stroke 6-month,12-month, 24-month, 36-month, 60-month Rate of patients with new stroke
Vascular Graft infection 6-month,12-month, 24-month, 36-month, 60-month Rate of patients with vascular Graft infection
All-cause mortality 30-day, 6-month,12-month, 24-month, 36-month, 60-month Rate of all-cause mortality
Pseudoaneurysm at the sutures or in the Vascular Graft 6-month,12-month, 24-month, 36-month, 60-month Rate of patients with pseudoaneurysm at the sutures or in the Vascular Graft
New sepsis 6-month,12-month, 24-month, 36-month, 60-month Rate of patients with new sepsis
Trial Locations
- Locations (1)
Universitätsklinikum Münster
🇩🇪Münster, NRW, Germany