Health TrialsbyHealthPanel

Clinical Trial of Thrombectomy Systems

ConditionDeep Vein Thrombosis (DVT)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrosMed Medical Co., Ltd

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • Peripheral thrombectomy system

    Device

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

Treatment groups

167 Participants
are divided into 1 treatment group
Group A: Test groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Technical success rate

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

Time frame
Immediately after procedure, 0 day

Secondary outcomes

1

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.

Time frame
30 days
2

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.

Time frame
Immediately after procedure, 0 day
3

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.

Time frame
Baseline, 1 Month, 6 Months
4

Vein Patency

The number of patients who have vein patency as measured by duplex ultrasound, CTV, or DSA.

Time frame
at 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

BrosMed Medical Co., Ltd

Lead sponsor

Source ClinicalTrials.gov
Apply now