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COMPLETED
NCT07857850
NA

A Prospective, Multicenter, Single-Arm Trial of Peripheral Vein Thrombectomy Stent System in Deep Venous Thrombosis

Sponsor: Shanghai TENDFO Medical Technology Co., Ltd.

View on ClinicalTrials.gov

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

Interventions

DEVICE

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