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
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
Treatments tested in this trial
- Peripheral thrombectomy system
Treatment groups
167 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov