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New treatment option for Deep Vein Thrombosis
Official title PROfunda Femoris Vein Thrombosis Evaluation and Clearance to Improve Outcomes of Endovascular Treatment for Acute Iliofemoral Deep Vein Thrombosis
ClinicalTrials.gov ID: NCT07622199
What this study is testing
- What it's testing
- Patients with iliofemoral vein thrombosis are prone to developing post-thrombotic syndrome (PTS). The profunda femoris vein (PFV) is an important inflow of the iliofemoral vein.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- Age ≥ 18 years and ≤ 85 years;
- Diagnosed with acute iliofemoral DVT involving iliac vein, common femoral vein, and PFV (confirmed by preoperative ultrasound, CT venography, or...
- Time from symptom onset to endovascular treatment ≤ 14 days;
- Patient receives endovascular treatment with PMT;
- Patient provides written informed consent.
You likely can't join if
- Presence of pre-existing PTS in the limb scheduled for treatment, or a history of symptomatic DVT in the same limb;
- Concurrent symptomatic acute DVT involving the iliac vein and/or common femoral vein in the contralateral limb;
- Known allergy to heparin, low-molecular-weight heparin, contrast media, or other relevant agents;
- Concomitant severe pulmonary embolism with hemodynamic compromise, such as hypoxia or hypotension;
- Intolerance to endovascular intervention due to concurrent acute systemic illness, severe dyspnea, or other contraindications;
- Concomitant severe renal insufficiency with creatinine clearance \< 30 ml/min;
See the full eligibility criteria
- Age ≥ 18 years and ≤ 85 years;
- Diagnosed with acute iliofemoral DVT involving iliac vein, common femoral vein, and PFV (confirmed by preoperative ultrasound, CT venography, or pre-procedural venography);
- Time from symptom onset to endovascular treatment ≤ 14 days;
- Patient receives endovascular treatment with PMT;
- Patient provides written informed consent.
- Presence of pre-existing PTS in the limb scheduled for treatment, or a history of symptomatic DVT in the same limb;
- Concurrent symptomatic acute DVT involving the iliac vein and/or common femoral vein in the contralateral limb;
- Known allergy to heparin, low-molecular-weight heparin, contrast media, or other relevant agents;
- Concomitant severe pulmonary embolism with hemodynamic compromise, such as hypoxia or hypotension;
- Intolerance to endovascular intervention due to concurrent acute systemic illness, severe dyspnea, or other contraindications;
- Concomitant severe renal insufficiency with creatinine clearance \< 30 ml/min;
- Presence of active bleeding, severe hepatic insufficiency, bleeding diathesis, or other coagulation disorders;
- Concomitant severe anemia (hemoglobin \< 8.0 mg/dL) or thrombocytopenia (platelet count \< 80,000/mL);
- History of subarachnoid hemorrhage, intracranial hemorrhage, intracranial vascular malformation, or intracranial aneurysm;
- Pregnancy;
- Presence of other diseases (e.g., advanced malignancy, cardiac insufficiency) with an estimated life expectancy \< 24 months;
- Participation in another clinical trial of a drug or medical device within the past 1 month that may interfere with the present study;
- Unwillingness to participate in this trial.
The study team makes the final eligibility decision.
Where it's taking place
- 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 - 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 to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.