A Clinical Trial to Evaluate the Efficacy and Safety of a Spot Stent System Used in Femoropopliteal Arteries.
Study Details
Study Description
Brief Summary
A prospective randomized trial designed to compare the efficacy and safety of spot stent system versus self-expanding peripheral stent system in the endovascular treatment of femoropopliteal arterial stenotic disease.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The objective of this clinical investigation is to assess the efficacy and safety of spot stent system ,which is indicated for use in patients with atherosclerotic disease of the superficial femoral artery (SFA) or proximal popliteal arteries and for the treatment of insufficient results after percutaneous transluminal angioplasty.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Spot stent system A system that loaded multi low radial force stents on one catheter. |
Device: Spot stent system
Spot stent system designed and produced by Acotec
|
| Active Comparator: Self-Expanding peripheral stent system A conventional stent system that commonly used. |
Device: Self-expanding peripheral stent system
Self-expanding peripheral stent system designed and produced by Ev3, Inc
|
Outcome Measures
Primary Outcome Measures
- The primary patency rate of target lesion at 12 months post-procedure [12 months post-procedure]
Defined as freedom from clinically driven target lesion revascularization (CD-TLR) and binary restenosis (restenosis defined as duplex ultrasound (DUS) peak systolic velocity ratio (PSVR) ≥2.4)
Secondary Outcome Measures
- Rate of device success [immediate post-procedure]
Defined as successful delivery, release and retrieval of the device.
- Rate of procedural success [7 days post-procedure]
Defined as no provisional stent implanted or major adverse event occured prior to discharge.
- Rate of clinically driven target lesion revascularization within 12 months post-procedure [12 months post-procedure]
Defined as any reintervention at the target lesion due to the following symptoms: drop of ABI >20% or ABI >0.15 compared to the post-procedure ABI
- The change of Rutherford class from baseline [12 months post-procedure]
Defined as change in target limb Rutherford class from baseline to 12 months
- The change of ankle-brachial index (ABI) from baseline [12 months post-procedure]
Defined as change of target limb ABI from baseline to 12 months
- Rate of composite safety endpoint [30 days post-procedure]
Defined a composite rate of all cause death, major target limb amputation (above-the-ankle amputation), clinically driven target lesion revascularization (CD-TLR) through 30 days post- procedure
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥18 years old and ≤80 years old
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Had lower extremity arterial occlusive diseases, and Rutherford classification is 2-5
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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.
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Target lesion had severe stenosis (stenosis degree ≥70%) or occlusion.
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Presence of at least one patent infrapopliteal vessel.
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The length of target lesion ≥10 cm.
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After predilation, the target lesion has <30% residual stenosis and presence of at least one flow-limiting dissection (by visual estimate).
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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:
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The plasma creatinine level is higher than 150 umol/L.
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Thrombolysis or thrombectomy is required.
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The patient had underwent lower-limb arterial surgery or thrombolysis on the target limb within 6 weeks.
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Previously implanted stent in the target lesion.
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The guide wire can not cross the target lesion.
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Angiographic evidence of calcification severe enough that it renders the target lesion non-dilatable.
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Patient has a known allergy to anticoagulant drugs, anti-platelet drugs or contrast medium that cannot be adequately pre-medicated.
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Women who are pregnant or breast-feeding.
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The subjects have participated in other drug property studies or device studies that have not yet completed the main end point.
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Patient has life expectancy of less than 12 months.
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Patient who planned to do above the ankle amputation before the operation.
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Patient who had severe hemorrhage or coagulation disorder which judged by the investigator.
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The investigator think the patient is not suitable for participation in the clinical trial.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Zhejiang Provincial People'S Hospital | Zhejiang | Zhejiang | China | 310014 |
Sponsors and Collaborators
- Acotec Scientific Co., Ltd
Investigators
- Principal Investigator: Guo Wei, MD, Chinese PLA General Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Acoart-08