- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03026049
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
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
-
-
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
|
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.
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.
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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