Zilver PTX Post-Market Study in Japan
Zilver PTX Post-Market Surveillance Study of Paclitaxel-Eluting Stents for Treating Femoropopliteal Artery Disease in Japan
1 other identifier
interventional
909
0 countries
N/A
Brief Summary
Japanese post market clinical study of the Zilver PTX device.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2012
Longer than P75 for not_applicable
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
CompletedFirst Submitted
Initial submission to the registry
September 24, 2014
CompletedFirst Posted
Study publicly available on registry
October 2, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2018
CompletedJuly 12, 2019
July 1, 2019
6.2 years
September 24, 2014
July 10, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Occurrence of stent fracture
5 years
Rate of adverse events
5 years
Study Arms (1)
Zilver PTX
EXPERIMENTALInterventions
Eligibility Criteria
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
Related Publications (4)
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.
PMID: 33084502DERIVEDDake 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: 33025243DERIVEDKichikawa 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.
PMID: 30411151DERIVEDYokoi 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.
PMID: 26847118DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael D Dake, MD
Department of Cardiothoracic Surgery, Stanford University Medical Center, Stanford, CA
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 24, 2014
First Posted
October 2, 2014
Study Start
May 1, 2012
Primary Completion
June 30, 2018
Study Completion
June 30, 2018
Last Updated
July 12, 2019
Record last verified: 2019-07