About this trial
To evaluate the efficacy and safety of combination of anticoagulant and antiplatelet therapy on the patency of iliac vein at 12-month post stenting in patients with acute proximal DVT and ipsilateral iliac vein stenosis who received percutaneous mechanic thrombectomy and iliac vein stenting.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Single group
Treatments tested in this trial
Rivaroxaban
DrugFor anticoagulant, it is rivaroxaban 20mg once a day for 6 months.
Aspirin
DrugFor antiplatelet therapy, it is aspirin 100mg once a day indefinitely.
Treatment groups
Trial outcomes
Primary outcomes
Primary Effectiveness Endpoints
The primary patency at 12-month follow-up evaluated by DUS
Primary Safety Endpoints
The rate of major bleeding events (BARC type 5 or type 3) based on BARC definitions at 12-month follow-up.
Secondary outcomes
Patency
The primary patency at 3-month and 6-month follow-up
The rate of bleeding events
The rate of bleeding events based on BARC definitions at 3-month, 6-month and 12-month follow-up
The rate and severity of post-thrombotic syndrome
The rate and severity of post-thrombotic syndrome (Villalta score) at 3-month, 6-month and 12-month follow-up
The recurrence rate of deep venous thrombosis
The recurrence rate of deep venous thrombosis evaluated by DUS at 3-month, 6-month and 12-month follow-up
Sponsors and contacts
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First Affiliated Hospital of Zhejiang University
Lead sponsor
Zhejiang University
Collaborator
Ningbo No.2 Hospital
Collaborator
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
Collaborator
The Central Hospital of Lishui City
Collaborator
Taizhou Enze Medical Center Group
Collaborator
Taizhou First People's Hospital
Collaborator
Boston Scientific Corporation
Collaborator