Post Market Clinical Follow-up, retrospective and prospective, observational Study of the IP Medical Vein Stent: "blueflow Venous Stent"

Post Market Clinical Follow-up, retrospective and prospective, observational Study of the IP Medical Vein Stent: "blueflow Venous Stent" - blueflow PMCF

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00014827

Enrollment

Registered

2018-06-12

Start date

2018-06-12

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I80.20

Interventions

Group 1: Patency rates and clinical outcome after implantation of the CE-marked IP-Medical Vein Stent "blueflow Venous Stent" for iliofemoral residual thrombosis, obstruction or stenosis. Observation

after 3, 6, 12 months, and then yearly up to 5 years.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Primary patency rate and primary sustained clinical success after 3 month follow up time.	—

Secondary

Measure	Time frame
• Patency rates (primary assisted patency rate, secondary patency rate) • Revised Venous Clinical Severity Score and CEAP-Score • Target vessel revascularization • Adverse Events o Stent-related: Rethrombosis (early and late), In-Stent restenosis, stent compression/fracture o Clinical: Postthrombotic syndrome, Bleeding (major, minor), Death (VTE-related, bleeding-related, other), Recurrent VTE at any site	—

Measure

Time frame

• Patency rates (primary assisted patency rate, secondary patency rate) • Revised Venous Clinical Severity Score and CEAP-Score • Target vessel revascularization • Adverse Events o Stent-related: Rethrombosis (early and late), In-Stent restenosis, stent compression/fracture o Clinical: Postthrombotic syndrome, Bleeding (major, minor), Death (VTE-related, bleeding-related, other), Recurrent VTE at any site

—

Countries

Germany, Switzerland

Contacts

Public ContactGeorg Landsberg

IP Medical GmbH

GLandsberg@abmedica.org+49 (0)211 585 881-0

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Apr 4, 2026