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A Prospective, Multicenter, Single-Arm Trial of Peripheral Vein Thrombectomy Stent System in Deep Venous Thrombosis
Sponsor: Shanghai TENDFO Medical Technology Co., Ltd.
Summary
To evaluate the safety and efficacy of peripheral vein thrombectomy stent system produced by Shanghai Tendfu Medical Technology Co., Ltd. in the treatment of acute or subacute deep venous thrombosis.
Official title: A Prospective, Multicenter, Single-Arm Trial to Evaluate the Safety and Efficacy of the Peripheral Vein Thrombectomy Stent System in the Treatment of Deep Venous Thrombosis
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
132
Start Date
2022-08-01
Completion Date
2023-08-30
Last Updated
2026-10-05
Healthy Volunteers
No
Conditions
Interventions
Peripheral Vein Thrombectomy Stent System
Tendfast™ Peripheral Vein Thrombectomy Stent System (Tendfast™) is a mechanical thrombectomy system consisting of a peripheral vein thrombectomy stent and a thrombus aspiration catheter. Guided by a guidewire, the stent is delivered to the thrombus, deployed against the vessel wall to engage, scrape, and collect the thrombus into its mesh for removal, after which manual negative-pressure aspiration through the catheter clears residual thrombus and restores blood flow.
Locations (6)
Xiamen Cardiovascular Hospital Xiamen University
Xiamen, Fujian, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangzhou, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Shanghai Pudong Hospital
Shanghai, China