NCT02254356

Brief Summary

Japanese post market clinical study of the Zilver Flex device.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
239

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

May 1, 2012

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

September 29, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 1, 2014

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 26, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 26, 2017

Completed
Last Updated

March 30, 2018

Status Verified

March 1, 2018

Enrollment Period

5.7 years

First QC Date

September 29, 2014

Last Update Submit

March 29, 2018

Conditions

Peripheral Arterial Disease (PAD)

Keywords

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

Outcome Measures

Primary Outcomes (2)

  • Occurrence of stent fracture

    3 years

  • Rate of adverse events

    3 years

Study Arms (1)

Zilver

EXPERIMENTAL
Device: Zilver Flex Bare Metal Stent

Interventions

Zilver Flex Bare Metal StentDEVICE
Zilver

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fukuoka Sanno Hospital

Fukuoka, 814-0001, Japan

Location

MeSH Terms

Conditions

Peripheral Arterial DiseasePeripheral Vascular Diseases

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Michael D Dake, MD

    Department of Cardiothoracic Surgery, Stanford University Medical Center, Stanford, CA

    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

September 29, 2014

First Posted

October 1, 2014

Study Start

May 1, 2012

Primary Completion

December 26, 2017

Study Completion

December 26, 2017

Last Updated

March 30, 2018

Record last verified: 2018-03

Locations

JP(1)