Clinical Trial: Bern Venous Stent Registry

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

Official Title: Bern Venous Stent Registry

Brief Summary: The purpose of this study is to examine patency rates of self-expanding nitinol stents for treatment of iliofemoral and inferior vena cava residual thrombosis, obstruction or stenosis. Moreover, clinical outcome data of patients treated with these venous stents will be collected.

Detailed Summary:

Background: Obstruction and stenosis of the ilio-femoro-caval veins are difficult to treat by conservative measures only. Despite anticoagulation and consequent use of compression stockings, lower extremity venous hypertension affects patients quality of life and health status by causing venous claudication, swelling, skin changes, and venous ulcers. In the last decades venous stenting has become an accepted treatment for ilio-femoro-caval obstruction. Recently, novel self-expanding nitinol stents have been specifically designed for the venous system to account for the anatomical structure of ilio-femoro-caval veins.

Gap of Knowledge: There are few data on short and long term outcomes of self-expanding Nitinol stent placement in ilio-femoro-caval veins.

Objective: To study patency rates and clinical outcome data of self-expanding Nitinol stents that were specifically designed for iliofemoral and inferior vena cava residual thrombosis, obstruction or stenosis.


Sponsor: University Hospital Inselspital, Berne

Current Primary Outcome: Primary patency rate [ Time Frame: after one year up to a follow-up of five years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Primary assisted patency rate [ Time Frame: after one year up to a follow-up of five years ]
  • Target vessel revascularization [ Time Frame: after one year up to a follow-up of five years ]
  • Secondary patency rate [ Time Frame: after one year up to a follow-up of five years ]
  • Revised Venous Clinical Severity Score [ Time Frame: after one year up to a follow-up of five years ]
  • CEAP-Score [ Time Frame: after one year up to a follow-up of five years ]
  • Adverse events: Stent-related: Rethrombosis (early and late), In-Stent restenosis, Stent compression/fracture Clinical: Postthrombotic syndrome, Bleeding (major, minor), Death (VTE-related, Bleeding-related, other), Recurrent VTE at any site [ Time Frame: after one year up to a follow-up of five years ]


Original Secondary Outcome: Same as current

Information By: University Hospital Inselspital, Berne

Dates:
Date Received: March 27, 2015
Date Started: January 2015
Date Completion: December 2020
Last Updated: May 2, 2017
Last Verified: May 2017