Clinical trial for Deep Vein Thrombosis (DVT)
Official title Clinical Trial of Thrombectomy Systems
ClinicalTrials.gov ID: NCT07749820
What this study is testing
- What it's testing
- The study will see if the device is safe and works to clear clots in the lower leg veins.
- Who it's for
- Adults who have a deep vein thrombosis in a leg vein.
- What's involved
- Participants will have the device used during a procedure, then follow-up visits and tests at discharge and at 1, 3, and 6 months.
- Time commitment
- The study lasts about 6 months, with visits at screening, the procedure day, discharge, and at 1, 3, and 6 months after the procedure.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
- Investigator-assessed life expectancy ≥1 year;
- Willing to participate in this study and provide written informed consent.
You likely can't join if
- 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 treatment 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;
See the full eligibility 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.
- 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 treatment 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Shanghai, China. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.