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Zilver Flex Post-Market Study in Japan

Primary Purpose

Peripheral Arterial Disease (PAD)

Status

Completed

Phase

Not Applicable

Locations

Japan

Study Type

Interventional

Intervention

Zilver Flex Bare Metal Stent

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease (PAD) focused on measuring drug-eluting stent, paclitaxel-eluting stent, peripheral artery disease, peripheral vascular disease, superficial femoral artery, popliteal artery

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

Exclusion Criteria:

Sites / Locations

Fukuoka Sanno Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Zilver

Arm Description

Outcomes

Primary Outcome Measures

Occurrence of stent fracture

Rate of adverse events

Secondary Outcome Measures

Full Information

NCT ID

NCT02254356

First Posted

September 29, 2014

Last Updated

March 29, 2018

Sponsor

Cook Group Incorporated

1. Study Identification

Unique Protocol Identification Number

NCT02254356

Brief Title

Zilver Flex Post-Market Study in Japan

Official Title

Zilver PTX Post-Market Surveillance Study of Bare Metal Stents for Treating Femoropopliteal Artery Disease in Japan

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

May 2012 (undefined)

Primary Completion Date

December 26, 2017 (Actual)

Study Completion Date

December 26, 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

Japanese post market clinical study of the Zilver Flex device.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Arterial Disease (PAD)

Keywords

drug-eluting stent, paclitaxel-eluting stent, peripheral artery disease, peripheral vascular disease, superficial femoral artery, popliteal artery

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

239 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Zilver

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Zilver Flex Bare Metal Stent

Primary Outcome Measure Information:

Title

Occurrence of stent fracture

Time Frame

3 years

Title

Rate of adverse events

Time Frame

3 years

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Symptomatic peripheral arterial disease (PAD) involving the above-the-knee femoropopliteal arteries Exclusion Criteria: -

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

Facility Information:

Facility Name

Fukuoka Sanno Hospital

City

Fukuoka

ZIP/Postal Code

814-0001

Country

Japan

12. IPD Sharing Statement

Learn more about this trial

Zilver Flex Post-Market Study in Japan

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