Clinical Of Chocolate Balloon Dilatation Versus Plain Balloon Dilatation to Treat Arteriosclerosis Occlusive Disease of Lower Extremity
NCT ID: NCT05158283
Last Updated: 2022-10-12
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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UNKNOWN
NA
144 participants
INTERVENTIONAL
2021-08-30
2022-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention: Chocolate balloon
Chocolate balloon group
chocolate balloon
chocolate balloon dilatation
Intervention: plain balloon
plain balloon group
plain balloon
plain balloon dilatation
Interventions
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chocolate balloon
chocolate balloon dilatation
plain balloon
plain balloon dilatation
Eligibility Criteria
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Inclusion Criteria
Exclusion criteria: 1. Acute or subacute lower limb ischemia caused by acute intraluminal thrombus within the target lesion.; 2. Severe calcified lesions （grade 4 in the PACSS scale）; 3. In-stent restenosis lesion or surgical arterial bypass grafting; 4. Severe renal insufficiency: creatinine level greater than 2.5 mg/dL; 5. Platelet count below 100,000/μL or with antiplatelet / anticoagulation contraindications; 6. Immunologic diseases or malignant diseases; 7. Ongoing active infection; 8. Decompensated congestive heart failure or acute coronary syndrome; 9. Refuse to sign the informed consent Unwillingness to comply with follow-up suggestions.
18 Years
ALL
No
Sponsors
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Xuanwu Hospital, Beijing
OTHER
Responsible Party
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Locations
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Gu Yong Quan
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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XuanwuH202109
Identifier Type: -
Identifier Source: org_study_id
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