Acoart SCB SFA: Sirolimus Coated Balloon Catheter in the Treatment of Femoropopliteal Artery Stenosis
NCT ID: NCT04982367
Last Updated: 2023-10-18
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
166 participants
INTERVENTIONAL
2021-12-08
2024-07-31
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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Sirolimus-eluting balloon angioplasty
Using Sirolimus Coated Balloon Catheter in the treatment of stenosis or occlusion in superficial femoral artery(SFA) and/or popliteal artery
Sirolimus-eluting balloon catheter
Sirolimus-eluting balloon catheter designed and produced by Acotec
Paclitaxel-eluting balloon angioplasty
Using Paclitaxel Coated Balloon Catheter in the treatment of stenosis or occlusion in superficial femoral artery(SFA) and/or popliteal artery
Paclitaxel-eluting balloon catheter
Paclitaxel-eluting balloon catheter (trade name:DHALIA)
Interventions
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Sirolimus-eluting balloon catheter
Sirolimus-eluting balloon catheter designed and produced by Acotec
Paclitaxel-eluting balloon catheter
Paclitaxel-eluting balloon catheter (trade name:DHALIA)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Had lower extremity arterial occlusive diseases, and Rutherford classification is 2-5
* SFA and/or popliteal artery had severe stenosis (stenosis degree ≥70%) or occlusion.
* The length of target lesion less than 20 cm
* Subject (or legal guardian) understands the study requirements and procedures and provides written Informed Consent before any study tests or procedures are performed
Exclusion Criteria
* Thrombolysis or thrombectomy is required
* There are more than 2 lesion need to treat in the target vessel.
* The patient had underwent lower-limb arterial surgery or thrombolysis on the target limb within 6 weeks.
* The target lesion had residual stenosis\>30% or flow-limit dissection after pre-dilatation.
* The patient had outflow less than 1 vessel
* The lesion located in a stent.
* Patient has a known allergy to aspirin, clopidogrel, heparin, paclitaxel, sirolimus or contrast medium that cannot be adequately pre-medicated.
* Women who are pregnant or breast-feeding.
* The subjects have participated in other drug property studies or device studies that have not yet completed the main end point.
* Patient has life expectancy of less than 12 months.
* The investigator think the patient is not suitable for participation in the clinical trial.
18 Years
80 Years
ALL
No
Sponsors
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Acotec Scientific Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Guo Wei, MD
Role: PRINCIPAL_INVESTIGATOR
Chinese PLA General Hospital
Locations
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Chinese PLA General Hospital
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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Acoart SCB SFA
Identifier Type: -
Identifier Source: org_study_id
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