Femoral Artery Occlusion, Femoral Artery Stenosis, Iliac Artery Occlusion, Iliac Artery Stenosis, Peripheral Arterial Disease, Popliteal Artery Occlusion, Popliteal Artery Stenosis
Conditions
Keywords
Peripheral Arterial Disease, Drug-eluting PTA Balloon Dilatation Catheter, Late Lumen Loss（6 months）
Brief summary
Clinical study on safety and efficacy of ZENFlow™ drug-eluting PTA balloon dilatation catheter in the treatment of iliac, femoral and popliteal artery stenosis or occlusion
Detailed description
The purpose of this study was to evaluate the safety and efficacy of ZENFlow™ drug-eluting PTA balloon dilatation catheter (paclitaxel 3±1 μg/mm2 balloon surface area) in the treatment of iliac artery, femoral artery and popliteal stenosis or occlusive lesions compared with conventional PTA balloon dilatation catheter.
Interventions
DEVICEZENFlow™ Drug-eluting PTA Balloon Dilatation Catheter
Digital subtraction angiography（DSA）
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 85 Years
Healthy volunteers
No
Inclusion criteria
* Aged from 18 to 85 years old, male or female * Subject's target lesions were stenosis and/or occlusion * Subjects were able to understand the purpose of the study, demonstrate full compliance with the program and sign informed consent
Exclusion criteria
* Pregnant woman or who's pregnancy test is positive * Lactation period woman or woman/man with fertility plan
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Late Lumen Loss at 6 months after operation | 6 months | Late Lumen Loss |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of major adverse events | 12 months | Related to death of clinical trials |
| Adverse Event | Preoperative、Intraoperative、up to 1 month、3 months、6 months、9 months、12 months | Adverse medical events, whether or not related to the medical device |
Outcome results
None listed