Peripheral Artery Disease
Conditions
Brief summary
This is a prospective, multicenter, randomized controlled trail using spot stenting to treat lower extremity post-angioplasty dissection.
Interventions
DEVICEthe spot stent(ZENFLEX ® Pinto) system
the spot stent(ZENFLEX ® Pinto) system、Color Doppler Ultrasonography (CDU) imaging、Dual Fluoroscopic Imaging、Digital subtraction angiography（DSA）
DEVICEthe bare stent( Everflex) system
the bare stent( Everflex) system、Color Doppler Ultrasonography (CDU) imaging、Dual Fluoroscopic Imaging、Digital subtraction angiography（DSA）
Sponsors
Zhejiang Zylox Medical Device Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age 18 to 80 years,male or female 2. Lower extremity atherosclerotic occlusive disease 3. 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) 4. 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
1. The target lesion has been stented or previously treated with bypass surgery 2. Acute thrombosis of the target vessel requires thrombolysis or thrombectomy, or has undergone local or systemic thrombolysis within 48 hours 3. Cutting balloon, thrombectomy, plaque resection, brachytherapy, and laser therapy were planned 4. 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 5. The target lesion was too calcified to undergo PTA or the guide wire could not pass anterograde through the target lesion 6. Planned amputation on the target limb 7. Severe allergy to anticoagulant drugs, antiplatelet drugs, contrast media and Nitinol 8. Uncontrollable infections 9. Women who are pregnant or breastfeeding, or who plan to become pregnant during the duration of the trial 10. Participating in clinical trials of any other drug or medical device and not yet out of the study 11. Other circumstances not suitable for inclusion as judged by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| primary patency rate at 12 months after operation | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| success rate of the device | Intraoperation |
| 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 |
| the incidence of major adverse events | 30 days, 6 months,12 months |
Countries
China
Contacts
Primary Contactjie Liang
Outcome results
None listed