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Recruiting NCT07749820

Clinical Trial of Thrombectomy Systems

No phase Interventional Deep Vein Thrombosis (DVT)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Peripheral thrombectomy system.
Who it may be relevant to
Registry conditions: Deep Vein Thrombosis (DVT). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

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

Primary outcome measures

  • Technical success rate [Time frame: Immediately after procedure, 0 day]
Secondary outcome measures (6)
  • Major adverse events (MAE) rate [Time frame: 30 days]
  • Device success rate [Time frame: Immediately after procedure, 0 day]
  • VCSS score [Time frame: Baseline, 1 Month, 6 Months]
  • Vein Patency [Time frame: at 6 months]
  • Incidence of PTS [Time frame: at 6 Months]
  • AE and SAE [Time frame: Up to 6 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Zhongshan Hospital, Fudan University — Shanghai

Identifiers

NCT: NCT07749820 · BM-D21

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗