Evaluating endovascular treatment for blood clots in the legs

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the safety and effectiveness of endovascular treatments for patients with acute or subacute thromboembolic occlusions in the lower extremities. It focuses on patients classified under Rutherford stages I to IIb, utilizing advanced tools such as drug-coated balloons and paclitaxel-eluting stents. The study aims to gather real-world data to determine optimal therapies, as current guidelines primarily recommend thrombectomy for stage IIb lesions. By tracking clinical outcomes, the research seeks to provide evidence for the efficacy of endovascular approaches in a broader patient population.

Why it matters

Who can join: the full rules

Inclusion criteria

1. Patients aged 18 years or older.
2. Diagnosis of acute or subacute limb ischemia classified as Rutherford classification stage I to IIb.
3. Rutherford classification ranging from 3 to 5.
4. Successful guidewire passage through the lesion of the femoropopliteal artery lesion, followed by further endovascular treatment. There are no restrictions will be implemented on the methods used for guidewire passage through the target lesion. The presence of thrombus must be confirmed via angiography and/or DSA and must be associated with occlusions of the lower extremity or ISR.
5. Mechanical thrombectomy device (MTD) and/or pharmacomechanical thrombectomy (PMT) and/or percutaneous aspiration thrombectomy(PAT) and/or CDT (catheter-directed thrombolysis) performed for thrombus removal.
6. The lower extremity artery must have a healthy runoff of at least 10 cm above the ankle with at least one healthy dorsalis pedis artery, medial plantar artery, or lateral plantar artery connecting to the digital artery below the ankle.
7. Informed consent signed by patients.

Exclusion criteria

1. Acute or subacute limb ischemia patients with Rutherford classification stage III.
2. Patients diagnosed with thromboangiitis obliterans.
3. Patients requring open surgery or hybrid operation after contrast radiography.
4. Patients with a history of stroke, cerebral hemorrhage, gastrointestinal bleeding, myocardial infarction, or similar conditions in the past 3 months.
5. Patients with known allergies to heparin, low molecular weight heparin, or contrast agents.
6. Patients at high risk for bleeding.
7. Pregnant or lactating women.
8. Patients with other conditions that may complicate study participation or significantly reduce life expectancy (\< 2 years), such as tumors, severe liver disease, and cardiac insufficiency.
9. Patients enrolled in other clinical studies within the past 3 months.
10. Patients unwilling or refusing to sign the informed consent form.

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Where it's running

• Fan xin
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Principal investigator: Meng Ye — RenJi Hospital
• Study coordinator: xin Fang
• Email: hzfhfx@126.com
• Phone: +08613867478324

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.