Deep Vein Thrombosis (DVT)NCT07749820
Clinical Trial of Thrombectomy Systems
A study testing Peripheral thrombectomy system in people with Deep Vein Thrombosis (DVT), run by BrosMed Medical Co., Ltd at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Vein Thrombosis (DVT)
- What is being tested?
- Peripheral thrombectomy system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 1 siteChina
- Study dates
- 30 Aug 2026to 30 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai, 200032
Fu, PhD, 021-31587871, fu.weiguo@zs-hospital.sh.cn
About this study
Official title: A Prospective, Multicenter, Single-Arm Clinical Trial Evaluating the Safety and Efficacy of Thrombectomy Systems for the Treatment of Lower Extremity Deep Vein Thrombosis
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)
- Being tested
- Peripheral thrombectomy system
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral thrombectomy systemDevice
For the subjects who met the requirements of the study protocol, the BM peripheral thrombectomy system was used for treatment.
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Thrombectomy system Receives: Device: Peripheral thrombectomy system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success rate
≥50% thrombus removal in the target venous segment as assessed by venography.
Measured: Immediately after procedure, 0 day
Secondary outcomes (6)
Major adverse events (MAE) rate
MAE is defined as all-cause death, major bleeding, symptomatic pulmonary embolism, or re-thrombosis of the target venous segment.
Measured: 30 days
Device success rate
Device success is defined as successful delivery of the thrombectomy catheter to the target lesion, smooth deployment during the procedure, and removal.
Measured: Immediately after procedure, 0 day
VCSS score
The number of patients that have improvement in Venous Clinical Severity Score (VCSS) which is a clinical assessment by the physician to score patient reported symptoms from a score of 0 to 3 based on severity. A score of 0 indicates absence of symptoms and a score of 3 indicates severe symptoms. The total score is the sum of all individual scores.
Measured: Baseline, 1 Month, 6 Months
Vein Patency
The number of patients who have vein patency as measured by duplex ultrasound, CTV, or DSA.
Measured: at 6 months
Incidence of PTS
Assessed by the Villalta score, patients with a score of ≥5 points are diagnosed with post-thrombotic syndrome (PTS).
Measured: at 6 Months
AE and SAE
Occurrence of adverse events (AE) and serious adverse events (SAE) during the study.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start30 Aug 2026 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Vein Thrombosis (DVT)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 167 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BrosMed Medical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07749820
- Sponsor's protocol ID
- BM-D21
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No