Anticoagulant Plus Antiplatelet Therapy Following Iliac Vein Stenting
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Deep Vein Thrombosis
- Iliac Vein Compression Syndrome
- Iliac Vein Obstruction
- Iliac Vein Stenosis
- Iliac Vein Thrombosis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
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 ...
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.
Tracking Information
- NCT #
- NCT04694248
- Collaborators
- Zhejiang University
- Ningbo No.2 Hospital
- Taizhou Hospital of Zhejiang Province
- The Central Hospital of Lishui City
- Taizhou Enze Hospital
- Taizhou First People's Hospital
- Boston Scientific Corporation
- Investigators
- Principal Investigator: Hongkun Zhang, M.D. First Affiliated Hospital of Zhejiang University