search
Back to results

Zilver® PTX® in China

Primary Purpose

Peripheral Artery Disease

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Zilver® PTX® Drug-Eluting Peripheral Stent
Sponsored by
Cook Group Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Artery Disease focused on measuring Zilver® PTX® Drug-Eluting Peripheral Stent, Above-the-Knee Femoropopliteal Artery, Chinese patient

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beijing Anzhen Hospital
  • China-Japan Friendship Hospital
  • Peking University First Hospital
  • Peking University People's Hospital
  • Peking Union Medical College Hospital
  • Chinese PLA General Hospital
  • Shanghai Ninth People's Hospital Affiliated Shanghai JiaoTong University School of Medicine
  • Zhongshan Hospital Fudan University
  • Renji Hospital Shanghai Jiaotong University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Zilver® PTX® VI

Arm Description

Outcomes

Primary Outcome Measures

Primary Patency as Assessed by Duplex Ultrasonography

Secondary Outcome Measures

Full Information

First Posted
June 18, 2014
Last Updated
March 21, 2017
Sponsor
Cook Group Incorporated
search

1. Study Identification

Unique Protocol Identification Number
NCT02171962
Brief Title
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

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
February 9, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cook Group Incorporated

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Artery Disease
Keywords
Zilver® PTX® Drug-Eluting Peripheral Stent, Above-the-Knee Femoropopliteal Artery, Chinese patient

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
178 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zilver® PTX® VI
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Zilver® PTX® Drug-Eluting Peripheral Stent
Intervention Description
Zilver® PTX® Drug-Eluting Peripheral Stent for treatment of lesions of the above-the-knee femoropopliteal artery
Primary Outcome Measure Information:
Title
Primary Patency as Assessed by Duplex Ultrasonography
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Dake, MD
Organizational Affiliation
Stanford University, CA, USA
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Changwei Liu, MD
Organizational Affiliation
Peking Union Medical College Hospital, Beijing, China
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Weiguo Fu, MD
Organizational Affiliation
Zhongshan Hospital Fudan University, Shanghai, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Anzhen Hospital
City
Beijing
ZIP/Postal Code
100029
Country
China
Facility Name
China-Japan Friendship Hospital
City
Beijing
ZIP/Postal Code
100029
Country
China
Facility Name
Peking University First Hospital
City
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Peking University People's Hospital
City
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Chinese PLA General Hospital
City
Beijing
ZIP/Postal Code
100853
Country
China
Facility Name
Shanghai Ninth People's Hospital Affiliated Shanghai JiaoTong University School of Medicine
City
Shanghai
ZIP/Postal Code
200011
Country
China
Facility Name
Zhongshan Hospital Fudan University
City
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Renji Hospital Shanghai Jiaotong University School of Medicine
City
Shanghai
ZIP/Postal Code
200127
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
36237908
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.
Results Reference
derived
PubMed Identifier
33025243
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.
Results Reference
derived

Learn more about this trial

Zilver® PTX® in China

We'll reach out to this number within 24 hrs