Stent Versus Conservative Treatment in Patients With Deep Venous Obstruction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-09

Study Completion Date

2021-10-07

Brief Summary

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Patients will be randomised between deep venous stenting or conservative management

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Detailed Description

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Conditions

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Deep-Venous Thrombosis Deep Venous Stenting Randomized Clinical Trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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deep venous stent

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

Group Type ACTIVE_COMPARATOR

deep venous stenting

Intervention Type DEVICE

Deep venous stent

conservative managment

Conservative management of complaints

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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deep venous stenting

Deep venous stent

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No