A Prospective, Multicenter, Single-Arm Clinical Trial Evaluating the Safety and Efficacy of Thrombectomy Systems for the Treatment of Lower Extremity Deep Vein Thrombosis
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This study plans to enroll 167 subjects. Subject enrollment and treatment details will be documented, and follow-up assessments will be conducted at screening, on the procedure day, before discharge, and at 1, 3, and 6 months after the procedure, to assess the safety and efficacy of the peripheral thrombectomy system for the treatment of lower extremity deep vein thrombosis.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age ≥18 years；
• Confirmed lower extremity deep vein thrombosis (DVT) by imaging, meeting at least one of the following: (1) acute iliofemoral or femoropopliteal DVT; or (2) subacute iliofemoral DVT;
• Investigator-assessed life expectancy ≥1 year;
• Willing to participate in this study and provide written informed consent.
Locations
Other Locations
China
Zhongshan Hospital, Fudan University
RECRUITING
Shanghai
Contact Information
Primary
Fu, PhD
fu.weiguo@zs-hospital.sh.cn
021-31587871
Time Frame
Start Date: 2026-08-30
Estimated Completion Date: 2027-12-30
Participants
Target number of participants: 167
Treatments
Experimental: Test group
Thrombectomy system
Related Therapeutic Areas
Sponsors
Leads: BrosMed Medical Co., Ltd