Study Stopped
it was not possible to recruit the required amount of participants within a reseanable timefram.
Stent Versus Conservative Treatment in Patients With Deep Venous Obstruction
STEVECO
A Randomized Controlled Trial Comparing Venous Stenting With Conservative Treatment in Patients With Deep Venous Obstruction
1 other identifier
interventional
65
1 country
1
Brief Summary
Patients will be randomised between deep venous stenting or conservative management
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2017
CompletedFirst Posted
Study publicly available on registry
January 20, 2017
CompletedStudy Start
First participant enrolled
March 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 7, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 7, 2021
CompletedApril 8, 2022
March 1, 2022
4.6 years
January 17, 2017
March 31, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Quality of Life score
Quality of Life score
12 months
Study Arms (2)
deep venous stent
ACTIVE COMPARATORPatients will receive deep venous stenting in the iliaco(femoral) region
conservative managment
NO INTERVENTIONConservative management of complaints
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maastricht university medical center
Maastricht, Limburg, Netherlands
Related Publications (3)
Flumignan RL, Nakano LC, Flumignan CD, Baptista-Silva JC. Angioplasty or stenting for deep venous thrombosis. Cochrane Database Syst Rev. 2025 Feb 19;2(2):CD011468. doi: 10.1002/14651858.CD011468.pub2.
PMID: 39968829DERIVEDShekarchian S, Van Laanen J, Esmaeil Barbati M, Vleugels MJ, Nelemans P, Razavi MK, Mees B, Jacobs MJ, Jalaie H. Editor's Choice - Quality of Life after Stenting for Iliofemoral Venous Obstruction: A Randomised Controlled Trial with One Year Follow Up. Eur J Vasc Endovasc Surg. 2023 Nov;66(5):678-685. doi: 10.1016/j.ejvs.2023.07.044. Epub 2023 Jul 28.
PMID: 37517579DERIVEDvan Vuuren TM, van Laanen JHH, de Geus M, Nelemans PJ, de Graaf R, Wittens CHA. A randomised controlled trial comparing venous stenting with conservative treatment in patients with deep venous obstruction: research protocol. BMJ Open. 2017 Sep 11;7(9):e017233. doi: 10.1136/bmjopen-2017-017233.
PMID: 28893753DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 17, 2017
First Posted
January 20, 2017
Study Start
March 9, 2017
Primary Completion
October 7, 2021
Study Completion
October 7, 2021
Last Updated
April 8, 2022
Record last verified: 2022-03