Clinical Study of Focal Implant Used for Lower Extremity Post-angioplasty Dissection

Study Overview
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Brief Summary
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This is a prospective, multicenter, randomized controlled trail using spot stenting to treat lower extremity post-angioplasty dissection.

Official Title
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A Prospective, Multicenter, Randomized Controlled Trail Using Spot Stenting to Treat Lower Extremity Post-angioplasty Dissection

Conditions
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Peripheral Artery Disease

Intervention / Treatment
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* Device: the spot stent(ZENFLEX ® Pinto) system
* Device: the bare stent( Everflex) system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 to 80 years,male or female Lower extremity atherosclerotic occlusive disease After PTA, angiography showed less than 30% residual stenosis of the target lesion (based on visual estimation), and there is one or more dissection(Type A-F) Subjects are able to understand the purpose of the study, demonstrate full compliance with the procedure and follow-up and sign informed consent Exclusion Criteria: The target lesion has been stented or previously treated with bypass surgery Acute thrombosis of the target vessel requires thrombolysis or thrombectomy, or has undergone local or systemic thrombolysis within 48 hours Cutting balloon, thrombectomy, plaque resection, brachytherapy, and laser therapy were planned More than 30% residual stenosis of the inflow artery (based on visual estimation) after treatment, or there is no outflow artery in the target limb The target lesion was too calcified to undergo PTA or the guide wire could not pass anterograde through the target lesion Planned amputation on the target limb Severe allergy to anticoagulant drugs, antiplatelet drugs, contrast media and Nitinol Uncontrollable infections Women who are pregnant or breastfeeding, or who plan to become pregnant during the duration of the trial Participating in clinical trials of any other drug or medical device and not yet out of the study Other circumstances not suitable for inclusion as judged by the investigator

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ZENFLEX ® Pinto<br>subjects using the spot stent(ZENFLEX ® Pinto) system | Device: the spot stent(ZENFLEX ® Pinto) system<br>* the spot stent(ZENFLEX ® Pinto) system、Color Doppler Ultrasonography (CDU) imaging、Dual Fluoroscopic Imaging、Digital subtraction angiography（DSA）<br>|
| Active Comparator: Everflex<br>subjects using the bare stent(Everflex) system | Device: the bare stent( Everflex) system<br>* the bare stent( Everflex) system、Color Doppler Ultrasonography (CDU) imaging、Dual Fluoroscopic Imaging、Digital subtraction angiography（DSA）<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| primary patency rate at 12 months after operation |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| success rate of the device |  | Intraoperation | 
| success rate of the technique |  | post operation | 
| rate of CD-TLR |  | 6 months,12 months | 
| ABI |  | post operation, 6 months,12 months | 
| Rutherford classification |  | post operation, 6 months,12 months | 
| the incidence of major adverse events |  | 30 days, 6 months,12 months | 
| the rate of target limb major amputation |  | 30 days, 6 months,12 months | 
| the incidence of adverse events |  | Intraoperation, post operation, 30 days, 6 months,12 months | 
| the incidence of SAE |  | Intraoperation, post operation, 30 days, 6 months,12 months | 
| the rate of device defect |  | Intraoperation, 12 months |