Vascular Diseases
Conditions
Keywords
aortic, aneurysm, dissection, stenosis, PAU, IMH
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.
Interventions
DEVICEOpen repair
Open repair of the aorta and peripheral arteries
Sponsors
JOTEC GmbH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 30-day | Rate of in-hospital all-cause mortality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 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 primary patency | 6-month,12-month, 24-month, 36-month, 60-month | Rate of patients with Vascular Graft primary patency |
| 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 |
| Vascular Graft infection | 6-month,12-month, 24-month, 36-month, 60-month | Rate of patients with vascular Graft infection |
| New sepsis | 6-month,12-month, 24-month, 36-month, 60-month | Rate of patients with new sepsis |
| New stroke | 6-month,12-month, 24-month, 36-month, 60-month | Rate of patients with new stroke |
| 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) |
Countries
Germany
Contacts
Primary ContactHeike Fischer, Dr.
Backup ContactAlexander Oberhuber, Prof. Dr.
Outcome results
None listed