Drug-coated Balloon: To observe the effectiveness and safety of the drug-coated balloon in the treatment of lower extremity arteriosclerosis obliterans of the femoral popliteal artery segment.
Study 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 studies have been carefully designed, and most of them have excluded long-length lesions and severely calcified lesions. In addition to being used alone in the real word, drug-coated balloons (DCB) are also used in combination with stents or debulking devices, but in these randomized controlled studies (RCT) they are only compared with standard percutaneous transluminal angioplasty (PTA). Therefore, the investigators initiated this study, which is a prospective, multicenter, observational real-world study of short and long-term outcome in endovascular treatment of femoropopliteal arterial occlusive lesions with DCB.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Rutherford grade 2-5.
2. 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.
3. Patients who understand the purpose of this study, volunteer to participate in the experiment, sign informed consent and are willing to follow up.
4. The guide wire needs to pass through the lesion.
5. Life expectancy\> 24 months.
6. 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.
7. Patients who have received DCB intervention for both lower limbs can be enrolled in the group according to the intracavitary treatment time.
8. There is at least one continuous infrapopliteal outflow artery or obtained through intravascular reconstruction.
9. For combined aortic iliac artery disease, the blood flow can be recanalized after intravascular reconstruction without residual stenosis exceeding 50%.
Exclusion Criteria:
1. Patients with stroke, cerebral hemorrhage, gastrointestinal hemorrhage or myocardial infarction within 3 months before enrollment.
2. Patients who are known to be allergic to heparin, aspirin, other antiplatelet drugs, contrast agents, etc.
3. Patients who have participated in clinical trials of drugs or other medical devices that interfere with this clinical trial within the past 3 months.
4. Pregnant and lactating women.
5. Patients who are unable or unwilling to participate in this trial.
6. Patients with Berg's disease.
7. Patients who have undergone arterial bypass on the treatment side.
Primary outcome measure(s)
Freedom from clinically-driven target lesion revascularization(CD-TLR) rate at post-interventional — 48 months Clinically-driven target lesion revascularization (CD-TLR) is defined as any re-intervention within the target lesion due to symptoms or drop of ankle brachial index (ABI) of ≥20% or \>0.15 when compared to post-procedure baseline.
Major adverse events — 48 months Operation-related acute thrombosis, arterial embolism, major amputation and all-cause mortality.
Trial sites (9)
Facility
City
Region
Status
Zibo Feng
Wuhan
Hubei
Xuanwu Hospital Capital Medical University
Beijing
China
Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu
China
Hangzhou First People's hospital of Medical College of Zhejiang University
Hangzhou
China
the First Affiliated hospital of Medicine College of Zhejiang University
Hangzhou
China
Qingdao Haici hospital affiliated to Qingdao University
Qingdao
China
Renji Hospital of Shanghai Jiaotong University
Shanghai
China
Zhongshan Hospital of Fudan University
Shanghai
China
the second Affiliated Hospital of Medical College of Suzhou University
Suzhou
China
More Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.