Post Market Clinical Follow-up, retrospective and prospective, observational Study of the IP Medical Vein Stent: blueflow Venous Stent
- Conditions
- I80.20
- Registration Number
- DRKS00014827
- Lead Sponsor
- IP Medical GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 61
Inclusion Criteria
• All patients >18 years with:
• Residual thrombosis of iliofemoral veins and/or inferior vena cava after thrombus removal (by catheter-directed or pharmacomechanical thrombolysis)
• Post-thrombotic syndrome and chronic obstruction of iliofemoral veins and/or inferior vena cava
• Chronic venous insufficiency and presence of non-thrombotic venous stenosis of iliofemoral veins and/or inferior vena cava
Exclusion Criteria
• Age < 18 years
• No consent
• Inability to provide informed consent
• Allergy to Nitinol
• Pregnancy, breast-feeding or birth giving during the last 30 days
• Life expectancy <3 months
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary patency rate and primary sustained clinical success after 3 month follow up time.
- Secondary Outcome Measures
Name Time Method • Patency rates (primary assisted patency rate, secondary patency rate) <br>• Revised Venous Clinical Severity Score and CEAP-Score<br>• Target vessel revascularization<br>• Adverse Events<br>o Stent-related: Rethrombosis (early and late), In-Stent restenosis, stent compression/fracture<br>o Clinical: Postthrombotic syndrome, Bleeding (major, minor), Death (VTE-related, bleeding-related, other), Recurrent VTE at any site<br>