A Post-Market Clinical Follow-up Study in Patients Treated With Vascular Grafts

Study Overview
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Brief Summary
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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
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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.

Official Title
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FLOWGRAFT - A Post-Market Clinical Follow-up Study in Patients Treated With Vascular Grafts

Conditions
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Vascular Diseases

Intervention / Treatment
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* Device: Open repair


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Open repair|Open repair of the aorta and peripheral arteries|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Rate of in-hospital all-cause mortality | 30-day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | Rate of all-cause mortality | 30-day, 6-month,12-month, 24-month, 36-month, 60-month | 
| Vascular Graft-related adverse event | Rate of patients with Vascular Graft-related adverse event | 30-day, 6-month,12-month, 24-month, 36-month, 60-month | 
| Freedom from Vascular Graft -related hemorrhage | Rate of patients with freedom from Vascular Graft -related hemorrhage | 6-month,12-month, 24-month, 36-month, 60-month | 
| Vascular Graft stenosis > 50% or occlusion | Rate of patients with Vascular Graft stenosis > 50% or occlusion | 6-month,12-month, 24-month, 36-month, 60-month | 
| Vascular Graft primary patency | Rate of patients with Vascular Graft primary patency | 6-month,12-month, 24-month, 36-month, 60-month | 
| Vascular Graft secondary patency (after reintervention) | Rate of patients with Vascular Graft secondary patency (after reintervention) | 6-month,12-month, 24-month, 36-month, 60-month | 
| Pseudoaneurysm at the sutures or in the Vascular Graft | Rate of patients with pseudoaneurysm at the sutures or in the Vascular Graft | 6-month,12-month, 24-month, 36-month, 60-month | 
| Vascular Graft infection | Rate of patients with vascular Graft infection | 6-month,12-month, 24-month, 36-month, 60-month | 
| New sepsis | Rate of patients with new sepsis | 6-month,12-month, 24-month, 36-month, 60-month | 
| New stroke | Rate of patients with new stroke | 6-month,12-month, 24-month, 36-month, 60-month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aortic, aneurysm, dissection, stenosis, PAU, IMH