A randomized controlled trial comparing venous stenting with conservative treatment in patients with Deep Venous Obstructio

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 130

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
-- Age >18 years
- Meet criteria for PTS
- Patients with May Thurner syndrome on additional imaging
- All patients with unilateral iliofemoral obstruction on radiological work up
expected to be treated solely percutaneous (without AV-fistula) based on post
thrombotic changes till above the femoral/ profundal confluents
- 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
- Bilateral disease
- Known pregnancy
- Inability to answer Dutch QoL questionnaires
- Contra-indication for prolonged anticoagulant treatment
- Recent, <1 year, deep venous thrombosis or pulmonary Embolism
- Known contrast allergy
- Known dialysis
- Uncontrolled or active coagulopathy or known uncorrectable bleeding diathesis
- Hypersensitivity to nitinol or nickel
- Known to be, or suspected of being unable to comply with the study protocol
(e.g. no permanent address, known to be non-compliant or presenting an unstable
psychiatric history)
- Legal incapacity and/or other circumstances rendering the subject unable to
understand the nature, scope and possible impact of the study
- Subjects in custody by juridical order
- Subjects who do not agree to the transmission of their pseudonymous data
within the liability of documentation and notification
- Close affiliation with the investigational site: e.g. a close relative of the
investigator or a possibly dependent person (e.g. employee or student of the
investigational site)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- The primary outcome is the change in QoL in patients with DVO at one year<br /><br>after PTA and stenting compared to conventional therapy (short class II elastic<br /><br>compressions stockings, exercise, lymph drainage therapy and the use of (pain)<br /><br>medication). based on VEINES-QOL/Sym </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters/endpoints<br /><br>Secondary outcomes are:<br /><br>- Change in QoL at 6 weeks-3months based on EuroQOL-5D, VEINES-QOL/Sym and pain<br /><br>disability index<br /><br>- Clinical assessment of complaints at 9-12 months, using the VCSS, the venous<br /><br>claudication and the Villalta score.<br /><br><br /><br>ii. Other study parameters<br /><br>- Complication rate in intervention group<br /><br>- Patency of stents in intervention group<br /><br>- Ulcer healing and recurrence<br /><br>- Recurrence of DVT or pulmonary embolism especially in MTS population </p><br>