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.
This study is a single-arm, prospective, open-label, multicenter study conducted in the Zhejiang Province, China. Randomized controlled trial is not an optimum option at this stage given the lack of high-quality data in terms of this hypothesis. Eligible subjects will include men and women with age of 18 years or older, who have a confirmed diagnosis of acute proximal DVT with ipsilateral iliac vein stenosis. A total of 172 subjects will be enrolled. The inclusion criteria and exclusion criteria are pre-defined. Subjects meeting all inclusion and no exclusion criteria will be eligible for enrollment. All subjects will receive the combination of anticoagulant and antiplatelet therapy after implanted with iliac vein stent. For anticoagulant, it is rivaroxaban 20mg once a day for 6 months. For antiplatelet therapy, it is aspirin 100mg once a day indefinitely.The duration of study participation for each subject is 12 months. Each subject will be followed at 3 months, 6 months and 12 months post-procedure. Efficacy endpoints and safety endpoints will be documented during the follow-up. After completing the follow-up, data will be analyzed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
172
For anticoagulant, it is rivaroxaban 20mg once a day for 6 months.
For antiplatelet therapy, it is aspirin 100mg once a day indefinitely.
The First Affliated Hospital, Zhejiang University, School of Medicine
Hangzhou, Zhejiang, China
RECRUITINGPrimary Effectiveness Endpoints
The primary patency at 12-month follow-up evaluated by DUS
Time frame: 12-month follow-up
Primary Safety Endpoints
The rate of major bleeding events (BARC type 5 or type 3) based on BARC definitions at 12-month follow-up.
Time frame: 12-month follow-up
Patency
The primary patency at 3-month and 6-month follow-up
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 3-month, 6-month and 12-month follow-up
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