Stent Versus Conservative Treatment in Patients With Deep Venous Obstruction

Randomized Clinical Trial Clinical Trial

— STEVECO  

Official title:

A Randomized Controlled Trial Comparing Venous Stenting With Conservative Treatment in Patients With Deep Venous Obstruction

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03026049
• Other study ID #: RCT DVO
• Status: Terminated
• Phase: N/A
• Start date: March 9, 2017
• Est. completion date: October 7, 2021

Study information

• Verified date: March 2022
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients will be randomised between deep venous stenting or conservative management

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 65
• Est. completion date: October 7, 2021
• Est. primary completion date: October 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age >18 years

• Meet criteria for PTS or

• Patients with May Thurner syndrome on additional imaging

• Life expectancy of more than one year

• Deep venous thrombosis > 1 year

• Signed informed consent

Exclusion Criteria:

• Previous intervention of central veins (inferior vena cava, iliac veins, common femoral vein) on the affected limb

• Known pregnancy

• Inability to answer Dutch QoL questionnaires or limited communication in Dutch (written and spoken)

• Contra-indication for prolonged anticoagulant treatment

• Recent, <1 year, deep venous thrombosis or pulmonary Embolism

• Known contrast allergy

• Known dialysis or renal insufficiency needing additional preparation for injection of contrast

Related Conditions & MeSH terms

• Deep Venous Stenting
• Deep-Venous Thrombosis
• Randomized Clinical Trial
• Thrombosis
• Venous Thrombosis

Intervention

Device:
• deep venous stenting
Deep venous stent

Locations

Country	Name	City	State
Netherlands	Maastricht university medical center	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life score	Quality of Life score	12 months