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The objective of this study is to evaluate the Zilver® PTX® Drug-Eluting Peripheral Stent for treatment of lesions of the above-the-knee femoropopliteal artery in a Chinese patient population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zilver® PTX® VI | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zilver® PTX® Drug-Eluting Peripheral Stent | Device | Zilver® PTX® Drug-Eluting Peripheral Stent for treatment of lesions of the above-the-knee femoropopliteal artery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Patency as Assessed by Duplex Ultrasonography | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Dake, MD | Stanford University, CA, USA | Study Director |
| Changwei Liu, MD | Peking Union Medical College Hospital, Beijing, China | Principal Investigator |
| Weiguo Fu, MD | Zhongshan Hospital Fudan University, Shanghai, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital | Beijing | 100029 | China | |||
| China-Japan Friendship Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36237908 | Derived | Ye W, Bohme T, Fu W, Liu C, Zhang X, Liu P, Zhang J, Zou Y, Lu X, Lottes AE, O'Leary EE, Zeller T, Dake MD. First peripheral drug-eluting stent clinical results from China: 1-year outcomes of the Zilver PTX China study. Front Cardiovasc Med. 2022 Sep 27;9:877578. doi: 10.3389/fcvm.2022.877578. eCollection 2022. | |
| 33025243 | Derived |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| Beijing |
| 100029 |
| China |
| Peking University First Hospital | Beijing | 100034 | China |
| Peking University People's Hospital | Beijing | 100044 | China |
| Peking Union Medical College Hospital | Beijing | 100730 | China |
| Chinese PLA General Hospital | Beijing | 100853 | China |
| Shanghai Ninth People's Hospital Affiliated Shanghai JiaoTong University School of Medicine | Shanghai | 200011 | China |
| Zhongshan Hospital Fudan University | Shanghai | 200032 | China |
| Renji Hospital Shanghai Jiaotong University School of Medicine | Shanghai | 200127 | China |
| Dake MD, Fanelli F, Lottes AE, O'Leary EE, Reichert H, Jiang X, Fu W, Iida O, Zen K, Schermerhorn M, Zeller T, Ansel GM. Prediction Model for Freedom from TLR from a Multi-study Analysis of Long-Term Results with the Zilver PTX Drug-Eluting Peripheral Stent. Cardiovasc Intervent Radiol. 2021 Feb;44(2):196-206. doi: 10.1007/s00270-020-02648-6. Epub 2020 Oct 6. |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |