A Prospective, Multicenter, Single-Arm Clinical Trial of Thrombectomy Systems

NCT07749820 | Recruiting

• 1 other identifier: BM-D21
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Deep Vein Thrombosis (DVT)

Outcome Measures

Primary Outcomes (1)

• Technical success rate

  ≥50% thrombus removal in the target venous segment as assessed by venography.

  Immediately after procedure, 0 day

Secondary Outcomes (6)

• Major adverse events (MAE) rate

  30 days

• Device success rate

  Immediately after procedure, 0 day

• VCSS score

  Baseline, 1 Month, 6 Months

• Vein Patency

  at 6 months

• Incidence of PTS

  at 6 Months

Study Arms (1)

Test group

EXPERIMENTAL

Thrombectomy system

Device: Peripheral thrombectomy system

Interventions

Peripheral thrombectomy system DEVICE

For the subjects who met the requirements of the study protocol, the BM peripheral thrombectomy system was used for treatment.

Test group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Infection at the puncture site or severe systemic infection;
• Inability to establish vascular access or difficulty in advancing the guidewire through the lesion;
• Hemodynamically unstable pulmonary embolism;
• The target lesion thrombosis is recurrent after prior interventional therapy;
• A venous stent has been implanted in the target lesion, or the presence of an inferior vena cava filter that interferes with device deployment;
• Bilateral lower extremity deep vein thrombosis requiring thrombectomy in the same procedure;
• Active bleeding within the past 30 days, including severe intracranial, gastrointestinal, or urinary tract bleeding;
• History of hemorrhagic or ischemic stroke within the past 30 days;
• Known severe coagulation disorder or bleeding tendency;
• Severe hepatic or renal impairment;
• Known allergy or significant hypersensitivity to iodine-based contrast media, thrombolytic agents, anticoagulants, or antiplatelet drugs;
• Known conditions such as severe hyperthyroidism, multiple myeloma, or severe heart failure that preclude tolerance to percutaneous transluminal angioplasty;
• Pregnant or lactating women, or women planning to become pregnant during the study period;
• Currently participating in any other clinical trial of a drug or medical device;
• Any other condition that, in the investigator's judgment, makes the subject ineligible for participation in this trial.

Sponsors & Collaborators

• BrosMed Medical Co., Ltd: lead

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, 200032, China

RECRUITING

MeSH Terms

Conditions

Venous Thrombosis

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Fu, PhD

CONTACT

021-31587871; fu.weiguo@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2026
• First Posted: August 6, 2026
• Study Start (Estimated): August 30, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: August 6, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)