search
Back to results

Zilver PTX Post-Market Study in Japan

Primary Purpose

Peripheral Arterial Disease (PAD)

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

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease (PAD)

Eligibility Criteria

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

Inclusion Criteria:

  • Symptomatic peripheral arterial disease (PAD) involving the above-the-knee femoropopliteal arteries

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Zilver PTX

    Arm Description

    Outcomes

    Primary Outcome Measures

    Occurrence of stent fracture
    Rate of adverse events

    Secondary Outcome Measures

    Full Information

    First Posted
    September 24, 2014
    Last Updated
    July 10, 2019
    Sponsor
    Cook Group Incorporated
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02254837
    Brief Title
    Zilver PTX Post-Market Study in Japan
    Official Title
    Zilver PTX Post-Market Surveillance Study of Paclitaxel-Eluting Stents for Treating Femoropopliteal Artery Disease in Japan
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2012 (undefined)
    Primary Completion Date
    June 30, 2018 (Actual)
    Study Completion Date
    June 30, 2018 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Japanese post market clinical study of the Zilver PTX device.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Peripheral Arterial Disease (PAD)

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Zilver PTX
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    Zilver PTX Drug-Eluting Stent
    Primary Outcome Measure Information:
    Title
    Occurrence of stent fracture
    Time Frame
    5 years
    Title
    Rate of adverse events
    Time Frame
    5 years

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Symptomatic peripheral arterial disease (PAD) involving the above-the-knee femoropopliteal arteries
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael D Dake, MD
    Organizational Affiliation
    Department of Cardiothoracic Surgery, Stanford University Medical Center, Stanford, CA
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    33084502
    Citation
    Sugimoto M, Komori K, Yokoi H, Ohki T, Kichikawa K, Nakamura M, Nanto S, O'Leary EE, Lottes AE, Saunders AT, Dake MD. Long-Term Effectiveness of a Drug-Eluting Stent for Femoropopliteal In-Stent Restenosis: Subanalysis of the Zilver PTX Japan Post-Market Surveillance Study. J Endovasc Ther. 2021 Apr;28(2):229-235. doi: 10.1177/1526602820966708. Epub 2020 Oct 21.
    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
    PubMed Identifier
    30411151
    Citation
    Kichikawa K, Ichihashi S, Yokoi H, Ohki T, Nakamura M, Komori K, Nanto S, O'Leary EE, Lottes AE, Snyder SA, Dake MD. Zilver PTX Post-market Surveillance Study of Paclitaxel-Eluting Stents for Treating Femoropopliteal Artery Disease in Japan: 2-Year Results. Cardiovasc Intervent Radiol. 2019 Mar;42(3):358-364. doi: 10.1007/s00270-018-2110-1. Epub 2018 Nov 8.
    Results Reference
    derived
    PubMed Identifier
    26847118
    Citation
    Yokoi H, Ohki T, Kichikawa K, Nakamura M, Komori K, Nanto S, O'Leary EE, Lottes AE, Snyder SA, Dake MD. Zilver PTX Post-Market Surveillance Study of Paclitaxel-Eluting Stents for Treating Femoropopliteal Artery Disease in Japan: 12-Month Results. JACC Cardiovasc Interv. 2016 Feb 8;9(3):271-277. doi: 10.1016/j.jcin.2015.09.035.
    Results Reference
    derived

    Learn more about this trial

    Zilver PTX Post-Market Study in Japan

    We'll reach out to this number within 24 hrs