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

A randomized controlled trial comparing venous stenting with conservative treatment in patients with Deep Venous Obstruction - RCT in Treatment of Deep Venous Obstruction

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON50291

Enrollment

130

Registered

2016-06-29

Start date

2017-03-10

Completion date

Unknown

Last updated

2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

May-Thurner syndrome Post thrombotic syndrome

Interventions

After inclusion patients will be stratified for PTS/ MTS group. Patients in the intervention group will be scheduled and treated with PTA and stenting. For this treatment patients should be administ

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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,

Design outcomes

Primary

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

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)