Stent Versus Conservative Treatment in Patients With Deep Venous Obstruction (STEVECO)

March 31, 2022 updated by: Maastricht University Medical Center

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

Patients will be randomised between deep venous stenting or conservative management

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands
        • Maastricht University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: deep venous stent
Patients will receive deep venous stenting in the iliaco(femoral) region
Device: deep venous stenting
Deep venous stent
No Intervention: conservative managment
Conservative management of complaints

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life score
Time Frame: 12 months
Quality of Life score
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2017

Primary Completion (Actual)

October 7, 2021

Study Completion (Actual)

October 7, 2021

Study Registration Dates

First Submitted

January 17, 2017

First Submitted That Met QC Criteria

January 17, 2017

First Posted (Estimate)

January 20, 2017

Study Record Updates

Last Update Posted (Actual)

April 8, 2022

Last Update Submitted That Met QC Criteria

March 31, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCT DVO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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