Deep-Venous ThrombosisSTEVECONCT03026049
Stent Versus Conservative Treatment in Patients With Deep Venous Obstruction
A study testing deep venous stenting in people with Deep-Venous Thrombosis and Deep Venous Stenting, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Patients will be randomised between deep venous stenting or conservative management Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep-Venous Thrombosis, Deep Venous Stenting, Randomized Clinical Trial
- What is being tested?
- deep venous stenting
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteNetherlands
- Study dates
- 9 Mar 2017to 7 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht university medical center
Maastricht, Limburg
About this study
Official title: 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
- Being tested
- deep venous stenting
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
deep venous stentingDevice
Deep venous stent
| Study group | Role | What they receive |
|---|---|---|
| deep venous stent | Active comparator | Patients will receive deep venous stenting in the iliaco(femoral) region Receives: Device: deep venous stenting |
| conservative managment | No intervention | Conservative management of complaints |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life score
Quality of Life score
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2017 (estimated)
- Study start9 Mar 2017
- Primary completion7 Oct 2021
- Study completion7 Oct 2021
Why it stopped: it was not possible to recruit the required amount of participants within a reseanable timefram.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Deep-Venous ThrombosisStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03026049
- Sponsor's protocol ID
- RCT DVO
- Acronym
- STEVECO
- Status last verified
- Mar 2022
- First submitted
- 17 Jan 2017
- Last updated
- 8 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39968829Shekarchian 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.
PubMed 37517579van 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.
PubMed 28893753
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Venous Stenting With Conservative Treatment in Patients With Deep Venous Obstruction
- ClinicalTrials.gov ID
- NCT03026049
- Acronym / sponsor ID
- STEVECO / RCT DVO
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: it was not possible to recruit the required amount of participants within a reseanable timefram.
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 9 Mar 2017 (actual)
- Primary completion
- 7 Oct 2021 (actual)
- Study completion
- 7 Oct 2021 (actual)
- First posted
- 20 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients will be randomised between deep venous stenting or conservative management
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| deep venous stent | Active comparator | Device: deep venous stentingPatients will receive deep venous stenting in the iliaco(femoral) region |
| conservative managment | No intervention | –Conservative management of complaints |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| deep venous stentingDeep venous stent | Device | deep venous stent |
Primary outcome
Quality of Life score
Time frame: 12 months
Quality of Life score
Results and safety
The study was stopped early (reason given: it was not possible to recruit the required amount of participants within a reseanable timefram.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
- Derived from this study: PubMed 39968829Flumignan 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.
- Derived from this study: PubMed 37517579Shekarchian 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.
- Derived from this study: PubMed 28893753van 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing deep venous stenting in people with Deep-Venous Thrombosis and Deep Venous Stenting, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: it was not possible to recruit the required amount of participants within a reseanable timefram.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life score (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03026049, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2022.