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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
167
For the subjects who met the requirements of the study protocol, the BM peripheral thrombectomy system was used for treatment.
Zhongshan Hospital, Fudan University
Shanghai, China
RECRUITINGTechnical success rate
≥50% thrombus removal in the target venous segment as assessed by venography.
Time frame: Immediately after procedure, 0 day
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
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
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
Vein Patency
The number of patients who have vein patency as measured by duplex ultrasound, CTV, or DSA.
Time frame: 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).
Time frame: at 6 Months
AE and SAE
Occurrence of adverse events (AE) and serious adverse events (SAE) during the study.
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Time frame: Up to 6 months