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

Primary Purpose

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

Status
Terminated
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
deep venous stenting
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Deep-Venous Thrombosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Maastricht university medical center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

deep venous stent

conservative managment

Arm Description

Patients will receive deep venous stenting in the iliaco(femoral) region

Conservative management of complaints

Outcomes

Primary Outcome Measures

Quality of Life score
Quality of Life score

Secondary Outcome Measures

Full Information

First Posted
January 17, 2017
Last Updated
March 31, 2022
Sponsor
Maastricht University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03026049
Brief Title
Stent Versus Conservative Treatment in Patients With Deep Venous Obstruction
Acronym
STEVECO
Official Title
A Randomized Controlled Trial Comparing Venous Stenting With Conservative Treatment in Patients With Deep Venous Obstruction
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
it was not possible to recruit the required amount of participants within a reseanable timefram.
Study Start Date
March 9, 2017 (Actual)
Primary Completion Date
October 7, 2021 (Actual)
Study Completion Date
October 7, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Patients will be randomised between deep venous stenting or conservative management

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep-Venous Thrombosis, Deep Venous Stenting, Randomized Clinical Trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
deep venous stent
Arm Type
Active Comparator
Arm Description
Patients will receive deep venous stenting in the iliaco(femoral) region
Arm Title
conservative managment
Arm Type
No Intervention
Arm Description
Conservative management of complaints
Intervention Type
Device
Intervention Name(s)
deep venous stenting
Intervention Description
Deep venous stent
Primary Outcome Measure Information:
Title
Quality of Life score
Description
Quality of Life score
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Maastricht university medical center
City
Maastricht
State/Province
Limburg
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
28893753
Citation
van 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.
Results Reference
derived

Learn more about this trial

Stent Versus Conservative Treatment in Patients With Deep Venous Obstruction

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