NCT02171962

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
178

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2014

Typical duration for not_applicable

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

June 18, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 24, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 9, 2017

Completed
Last Updated

March 22, 2017

Status Verified

March 1, 2017

Enrollment Period

1.5 years

First QC Date

June 18, 2014

Last Update Submit

March 21, 2017

Conditions

Peripheral Artery Disease

Keywords

Zilver® PTX® Drug-Eluting Peripheral StentAbove-the-Knee Femoropopliteal ArteryChinese patient

Outcome Measures

Primary Outcomes (1)

  • Primary Patency as Assessed by Duplex Ultrasonography

    12 months

Study Arms (1)

Zilver® PTX® VI

EXPERIMENTAL
Device: Zilver® PTX® Drug-Eluting Peripheral Stent

Interventions

Zilver® PTX® Drug-Eluting Peripheral StentDEVICE

Zilver® PTX® Drug-Eluting Peripheral Stent for treatment of lesions of the above-the-knee femoropopliteal artery

Zilver® PTX® VI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Beijing Anzhen Hospital

Beijing, 100029, China

Location

China-Japan Friendship Hospital

Beijing, 100029, China

Location

Peking University First Hospital

Beijing, 100034, China

Location

Peking University People's Hospital

Beijing, 100044, China

Location

Peking Union Medical College Hospital

Beijing, 100730, China

Location

Chinese PLA General Hospital

Beijing, 100853, China

Location

Shanghai Ninth People's Hospital Affiliated Shanghai JiaoTong University School of Medicine

Shanghai, 200011, China

Location

Zhongshan Hospital Fudan University

Shanghai, 200032, China

Location

Renji Hospital Shanghai Jiaotong University School of Medicine

Shanghai, 200127, China

Location

Related Publications (2)

  • 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.

    PMID: 36237908DERIVED

  • 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.

    PMID: 33025243DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2014

First Posted

June 24, 2014

Study Start

June 1, 2014

Primary Completion

December 1, 2015

Study Completion

February 9, 2017

Last Updated

March 22, 2017

Record last verified: 2017-03

Locations

CN(9)