Actively Recruiting
The Safety and Efficiency of Endovascular Treatment of Acute or Subacute Thromboembolic Occlusions of Lower Extremity.
Led by First People's Hospital of Hangzhou · Updated on 2025-09-15
400
Participants Needed
1
Research Sites
247 weeks
Total Duration
On this page
Sponsors
F
First People's Hospital of Hangzhou
Lead Sponsor
R
RenJi Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 extremity included stage IIb were treated with endovascular procedures. Most guidelines suggests only stage I and stage IIa lesions are suitable for endovascular treatments. Therefore, a well-designed real-world study that track the safety and clinical relevant outcomes, are required to determine the optimal therapies for patients with acute or subacute thromboembolic occlusions of lower extremity.
CONDITIONS
Official Title
The Safety and Efficiency of Endovascular Treatment of Acute or Subacute Thromboembolic Occlusions of Lower Extremity.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 femoropopliteal artery lesion confirmed by angiography or DSA
- Undergoing mechanical thrombectomy, pharmacomechanical thrombectomy, percutaneous aspiration thrombectomy, or catheter-directed thrombolysis for thrombus removal
- Lower extremity artery with healthy runoff at least 10 cm above the ankle and at least one healthy artery connecting below the ankle
- Signed informed consent
You will not qualify if you...
- Patients with acute or subacute limb ischemia classified as Rutherford stage III
- Diagnosis of thromboangiitis obliterans
- Need for open surgery or hybrid operation after contrast radiography
- History of stroke, cerebral hemorrhage, gastrointestinal bleeding, or myocardial infarction within the past 3 months
- Known allergies to heparin, low molecular weight heparin, or contrast agents
- High risk for bleeding
- Pregnant or lactating women
- Other conditions complicating participation or reducing life expectancy to less than 2 years, including tumors, severe liver disease, or cardiac insufficiency
- Participation in other clinical studies within the past 3 months
- Unwillingness or refusal to sign informed consent form
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fan xin
Hangzhou, Zhejiang, China, 310006
Actively Recruiting
Research Team
X
xin Fang
CONTACT
J
jianyun Long
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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