A Clinical Trial to Evaluate the Efficacy and Safety of a Spot Stent System Used in Femoropopliteal Arteries.
NCT ID: NCT05246410
Last Updated: 2023-11-29
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
NA
196 participants
INTERVENTIONAL
2022-08-17
2024-12-30
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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Spot stent system
A system that loaded multi low radial force stents on one catheter.
Spot stent system
Spot stent system designed and produced by Acotec
Self-Expanding peripheral stent system
A conventional stent system that commonly used.
Self-expanding peripheral stent system
Self-expanding peripheral stent system designed and produced by Ev3, Inc
Interventions
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Spot stent system
Spot stent system designed and produced by Acotec
Self-expanding peripheral stent system
Self-expanding peripheral stent system designed and produced by Ev3, Inc
Eligibility Criteria
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Inclusion Criteria
* Had lower extremity arterial occlusive diseases, and Rutherford classification is 2-5
* Target lesion is in the superficial femoral artery (SFA) and/or proximal popliteal artery (above the knee), located ≥1 cm below the common femoral artery (CFA) bifurcation to the distal segment of the proximal popliteal artery at the superior end of the patella.
* Target lesion had severe stenosis (stenosis degree ≥70%) or occlusion.
* Presence of at least one patent infrapopliteal vessel.
* The length of target lesion ≥10 cm.
* After predilation, the target lesion has \<30% residual stenosis and presence of at least one flow-limiting dissection (by visual estimate).
* 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.
* The patient had underwent lower-limb arterial surgery or thrombolysis on the target limb within 6 weeks.
* Previously implanted stent in the target lesion.
* The guide wire can not cross the target lesion.
* Angiographic evidence of calcification severe enough that it renders the target lesion non-dilatable.
* Patient has a known allergy to anticoagulant drugs, anti-platelet drugs 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.
* Patient who planned to do above the ankle amputation before the operation.
* Patient who had severe hemorrhage or coagulation disorder which judged by the investigator.
* 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
Zhejiang Provincial People'S Hospital
Zhejiang, Zhejiang, 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-08
Identifier Type: -
Identifier Source: org_study_id