Status:
ACTIVE_NOT_RECRUITING
A Study of Endovascular Treatment of Femoropopliteal Arterial Occlusive Lesion With Drug-Coated Balloon
Lead Sponsor:
Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
Collaborating Sponsors:
RenJi Hospital
Zhejiang University
Conditions:
Drug-coated Balloon
Femoropopliteal Artery Occlusion
Eligibility:
All Genders
18+ years
Brief Summary
There have been a number of randomized controlled studies (RCT) showing the efficacy of the endovascular treatment with drug-coated balloons (DCB) in the femoropopliteal artery lesions. However, these...
Detailed Description
Traditional endovascular approaches to the treatment of atherosclerotic disease in the femoropopliteal arteries include percutaneous transluminal angioplasty (PTA) with an uncoated balloon and implant...
Eligibility Criteria
Inclusion
- Rutherford grade 2-5.
- Femoral popliteal artery stenosis or occlusion, a clear outflow tract no less than 10cm long at the distal end of the knee should be continuous with a clear outflow tract under the ankle.
- Patients who understand the purpose of this study, volunteer to participate in the experiment, sign informed consent and are willing to follow up.
- The guide wire needs to pass through the lesion.
- Life expectancy\> 24 months.
- Patients with thrombosis of the lower extremities, patients who received drug-coated balloon (DCB) intervention after thrombus removal through mechanical thrombus removal, percutaneous catheter thrombolysis, and thrombus removal.
- Patients who have received DCB intervention for both lower limbs can be enrolled in the group according to the intracavitary treatment time.
- There is at least one continuous infrapopliteal outflow artery or obtained through intravascular reconstruction.
- For combined aortic iliac artery disease, the blood flow can be recanalized after intravascular reconstruction without residual stenosis exceeding 50%.
Exclusion
- Patients with stroke, cerebral hemorrhage, gastrointestinal hemorrhage or myocardial infarction within 3 months before enrollment.
- Patients who are known to be allergic to heparin, aspirin, other antiplatelet drugs, contrast agents, etc.
- Patients who have participated in clinical trials of drugs or other medical devices that interfere with this clinical trial within the past 3 months.
- Pregnant and lactating women.
- Patients who are unable or unwilling to participate in this trial.
- Patients with Berg's disease.
- Patients who have undergone arterial bypass on the treatment side.
Key Trial Info
Start Date :
February 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2027
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT04826705
Start Date
February 1 2021
End Date
February 1 2027
Last Update
March 5 2024
Active Locations (9)
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1
Zibo Feng
Wuhan, Hubei, China, 430000
2
Xuanwu Hospital Capital Medical University
Beijing, China
3
Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu, China
4
Hangzhou First People's hospital of Medical College of Zhejiang University
Hangzhou, China