Deep Vein Thrombosis (DVT)
Conditions
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.
Interventions
DEVICEPeripheral thrombectomy system
For the subjects who met the requirements of the study protocol, the BM peripheral thrombectomy system was used for treatment.
Sponsors
BrosMed Medical Co., Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical success rate | Immediately after procedure, 0 day | ≥50% thrombus removal in the target venous segment as assessed by venography. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse events (MAE) rate | 30 days | MAE is defined as all-cause death, major bleeding, symptomatic pulmonary embolism, or re-thrombosis of the target venous segment. |
| Device success rate | Immediately after procedure, 0 day | Device success is defined as successful delivery of the thrombectomy catheter to the target lesion, smooth deployment during the procedure, and removal. |
| VCSS score | Baseline, 1 Month, 6 Months | 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. |
| Vein Patency | at 6 months | The number of patients who have vein patency as measured by duplex ultrasound, CTV, or DSA. |
| Incidence of PTS | at 6 Months | Assessed by the Villalta score, patients with a score of ≥5 points are diagnosed with post-thrombotic syndrome (PTS). |
| AE and SAE | Up to 6 months | Occurrence of adverse events (AE) and serious adverse events (SAE) during the study. |
Countries
China
Contacts
CONTACTFu, PhD
Outcome results
None listed