Zilver PTX Post-Market Study in Japan

NCT ID: NCT02254837

Last Updated: 2019-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

909 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2018-06-30

Brief Summary

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Japanese post market clinical study of the Zilver PTX device.

Detailed Description

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Conditions

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Peripheral Arterial Disease (PAD)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Zilver PTX

Group Type EXPERIMENTAL

Zilver PTX Drug-Eluting Stent

Intervention Type DEVICE

Interventions

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Zilver PTX Drug-Eluting Stent

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Symptomatic peripheral arterial disease (PAD) involving the above-the-knee femoropopliteal arteries
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cook Group Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael D Dake, MD

Role: PRINCIPAL_INVESTIGATOR

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

References

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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.

Reference Type DERIVED
PMID: 33084502 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33025243 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30411151 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26847118 (View on PubMed)

Other Identifiers

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12-005-PTX

Identifier Type: -

Identifier Source: org_study_id

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