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Clinical Trials/NL-OMON50291
NL-OMON50291
Recruiting
Phase 4

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

Medisch Universitair Ziekenhuis Maastricht0 sites130 target enrollmentTBD
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ConditionsMay-Thurner syndromePost thrombotic syndrome100075101000318410047066

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
May-Thurner syndrome
Sponsor
Medisch Universitair Ziekenhuis Maastricht
Enrollment
130
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
Medisch Universitair Ziekenhuis Maastricht

Eligibility 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

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

Outcomes

Primary Outcomes

Not specified

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