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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | subjects using the drug-eluting PTA balloon dilatation catheter |
|
| Group B | Active Comparator | subjects using the peripheral balloon dilatation catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZENFlow™ Drug-eluting PTA Balloon Dilatation Catheter | Device | Digital subtraction angiography（DSA） |
|
| Measure | Description | Time Frame |
|---|---|---|
| Late Lumen Loss at 6 months after operation | Late Lumen Loss | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of major adverse events | Related to death of clinical trials | 12 months |
| Adverse Event | Adverse medical events, whether or not related to the medical device |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Changwei Liu | Peking Union Medical College Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35391838 | Derived | Ni L, Ye W, Zhang L, Jin X, Shu C, Jiang JS, Yang M, Wu DM, Li M, Yu GF, Yang J, Huang JH, Wang XB, Li XQ, Jiang WL, Wu ZQ, Liu CW. A Multicenter Randomized Trial Assessing ZENFlow Carrier-Free Drug-Coated Balloon for the Treatment of Femoropopliteal Artery Lesions. Front Cardiovasc Med. 2022 Mar 15;9:821672. doi: 10.3389/fcvm.2022.821672. eCollection 2022. |
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| Peripheral Balloon Dilatation Catheter | Device | Digital subtraction angiography（DSA） |
|
| Preoperative、Intraoperative、up to 1 month、3 months、6 months、9 months、12 months |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
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