Status:
RECRUITING
The Safety and Efficiency of Endovascular Treatment of Acute or Subacute Thromboembolic Occlusions of Lower Extremity.
Lead Sponsor:
First People's Hospital of Hangzhou
Collaborating Sponsors:
RenJi Hospital
First Affiliated Hospital of Zhejiang University
Conditions:
Thromboembolic Disease
Lower Extremity Problem
Eligibility:
All Genders
18+ years
Brief Summary
Based on the development of new tools, including drug coated balloon, paclitaxel eluting stent, interwoven stents, debulking tools, More and more acute or subacute thromboembolic occlusions of lower e...
Detailed Description
According to the Trans-Atlantic Inter-Society Consensus (TASC) II guidelines, acute arterial occlusion which in stage IIb was recommended for thrombectomy. However, with the development of new tools, ...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Patients aged 18 years or older.
- Diagnosis of acute or subacute limb ischemia classified as Rutherford classification stage I to IIb.
- Rutherford classification ranging from 3 to 5.
- 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.
- 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.
- 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.
- Informed consent signed by patients.
- Exclusion criteria
- Acute or subacute limb ischemia patients with Rutherford classification stage III.
- Patients diagnosed with thromboangiitis obliterans.
- Patients requring open surgery or hybrid operation after contrast radiography.
- Patients with a history of stroke, cerebral hemorrhage, gastrointestinal bleeding, myocardial infarction, or similar conditions in the past 3 months.
- Patients with known allergies to heparin, low molecular weight heparin, or contrast agents.
- Patients at high risk for bleeding.
- Pregnant or lactating women.
- 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.
- Patients enrolled in other clinical studies within the past 3 months.
- Patients unwilling or refusing to sign the informed consent form.
- \-
Exclusion
Key Trial Info
Start Date :
April 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT04861506
Start Date
April 1 2021
End Date
December 31 2025
Last Update
September 15 2025
Active Locations (1)
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1
Fan xin
Hangzhou, Zhejiang, China, 310006