Durg Coated Balloon Angioplasty in Infrapopliteal Lesions
NCT ID: NCT05620095
Last Updated: 2024-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1000 participants
OBSERVATIONAL
2020-12-01
2026-11-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Interventions
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drug-coated balloon
To evaluate the effectiveness and safety of drug-coated balloon angioplasty for infrapopliteal artery lesions in patients with CLTI.
Eligibility Criteria
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Inclusion Criteria
2. Patients who understand the purpose of this study, volunteer to participate in the experiment, sign informed consent and are willing to follow up.
3. Single or sequential de novo or restenotic lesions (stenosis ≥ 70% diameter reduction or occlusion) in the infrapopliteal arteries \>20 mm. Lesions should not extend beyond the ankle joint.
4. Successful wire crossing of the lesion. After the pre-dilation of the ordinary balloon, the angiography showed that there was continuous blood flow.
5. At least one of the infrapopliteal arteries received a drug-coated balloon.
6. For patients with aortoiliac artery disease and femoral-popliteal artery disease, after intravascular reconstruction, blood flow can be recanalized, and there is no residual stenosis of more than 50%.
7. In patients with lower extremity arterial thrombosis, after mechanical thrombectomy, percutaneous catheter thrombolysis, and thrombus removal, patients receiving blew the knee arterial drug balloon intervention.
8. Patients who have received DCB intervention for both lower limbs can be enrolled in the group according to the intracavitary treatment time.
9. Life expectancy\> 24 months.
Exclusion Criteria
2. Patients with stroke, cerebral hemorrhage, gastrointestinal hemorrhage or myocardial infarction within 3 months before enrollment.
3. Patients who are known to be allergic to heparin, aspirin, other antiplatelet drugs, contrast agents, etc.
4. Patients who have participated in clinical trials of drugs or other medical devices that interfere with this clinical trial within the past 3 months.
5. Pregnant and lactating women.
6. Patients with Berg's disease.
7. Patients requiring major amputation based on preoperative evaluation of limb infection or severe ischemia
18 Years
ALL
No
Sponsors
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Xuanwu Hospital, Beijing
OTHER
RenJi Hospital
OTHER
Zhejiang University
OTHER
First People's Hospital of Hangzhou
OTHER
Second Affiliated Hospital of Suzhou University
OTHER
Qingdao University
OTHER
Chengdu University of Traditional Chinese Medicine
OTHER
Shanghai Zhongshan Hospital
OTHER
Huashan Hospital
OTHER
Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
OTHER
Responsible Party
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Zibo Feng
Director of Vascular Surgery, Liyuan Hospital
Principal Investigators
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Zibo Feng
Role: PRINCIPAL_INVESTIGATOR
Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
Lianrui Guo
Role: PRINCIPAL_INVESTIGATOR
Xuanwu Hospital, Beijing
Locations
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Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China
Zibo Feng
Wuhan, Hubei, China
the second Affiliated Hospital of Medical College of Suzhou University
Suzhou, Jiangsu, China
Qingdao Haici hospital affiliated to Qingdao University
Qingdao, Shandong, China
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Renji Hospital of Shanghai Jiaotong University
Shanghai, Shanghai Municipality, China
Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan, China
Hangzhou First People's hospital of Medical College of Zhejiang University
Hangzhou, Zhejiang, China
the First Affiliated hospital of Medicine College of Zhejiang University
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Lianrui Guo
Role: primary
Hongfei Sang
Role: primary
Qiang Li
Role: primary
Weihao Shi
Role: primary
Meng Ye
Role: primary
Zhenyu Shi
Role: primary
Chunshui He
Role: primary
Xin Fang
Role: primary
Ziheng Wu
Role: primary
Other Identifiers
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the Act study
Identifier Type: -
Identifier Source: org_study_id
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