Clinical trial NCT02171962: Zilver® PTX® in China
Official title: Evaluation of the Zilver® PTX® Drug-Eluting Peripheral Stent for Treatment of Lesions of the Above-the-Knee Femoropopliteal Artery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Artery Disease
Keywords: Zilver® PTX® Drug-Eluting Peripheral Stent
Above-the-Knee Femoropopliteal Artery
Chinese patient
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2014-06-24
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Symptoms of peripheral arterial disease corresponding to Rutherford Classification 2-4
* Stenotic (\>50% diameter stenosis) or occluded lesion of the above-the knee femoropopliteal artery
* Reference vessel diameter of 4-9 mm
* Lesion length up to 140 mm

Exclusion Criteria:

* Unsuccessful arterial interventional treatment of the legs within 30 days prior to the study procedure
* Previous stent in the study vessel
* Bypass graft with an anastomosis in the study vessel
* Significant stenosis or occlusion of inflow tract not successfully treated prior to treating the study lesion
* No patent vessel of runoff

Primary outcomes:
measure: Primary Patency as Assessed by Duplex Ultrasonography
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital
city: Beijing
country: China
facility: China-Japan Friendship Hospital
city: Beijing
country: China
facility: Peking University First Hospital
city: Beijing
country: China
facility: Peking University People's Hospital
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Beijing
country: China
facility: Chinese PLA General Hospital
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital Affiliated Shanghai JiaoTong University School of Medicine
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
city: Shanghai
country: China
facility: Renji Hospital Shanghai Jiaotong University School of Medicine
Study officials:
affiliation: Stanford University, CA, USA
name: Michael Dake, MD
role: STUDY_DIRECTOR
affiliation: Peking Union Medical College Hospital, Beijing, China
name: Changwei Liu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhongshan Hospital Fudan University, Shanghai, China
name: Weiguo Fu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.