Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
200 participants
INTERVENTIONAL
2013-08-31
2021-02-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Zilver PTX Delivery System
NCT02271529
Post-Market Study of ZENFLEX Pro Stent for Femoropopliteal Artery Lesions
NCT07049120
Evaluation of the Zilver® Vena™ Venous Stent
NCT01663051
Paclitaxel-coated Peripheral Stents Used in the Treatment of Femoropopliteal Stenoses
NCT02936622
VIVO Clinical Study
NCT01970007
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Drug-Eluting Stent
Zilver® PTX® Drug-Eluting Peripheral Stent
Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Zilver® PTX® Drug-Eluting Peripheral Stent
Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patient has symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.
* Patient agrees to return for the required follow-up assessments.
Exclusion Criteria
* Patient has significant stenosis of inflow tract not successfully treated before this procedure.
* Patient lacks at least one patent vessel of runoff with \< 50% stenosis throughout its course.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cook Research Incorporated
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
VA Palo Alto Health Care System
Palo Alto, California, United States
Stanford University Medical School
Stanford, California, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
The Cardiac and Vascular Institute
Gainesville, Florida, United States
University of Florida
Gainesville, Florida, United States
First Coast Cardiovascular Institute
Jacksonville, Florida, United States
Alexian Brothers Medical Center
Elk Grove Village, Illinois, United States
Bayview Medical Center
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Columbia University Medical Center
New York, New York, United States
New York-Presbyterian/ Weill Cornell Medical Center
New York, New York, United States
OhioHealth Research Institute
Columbus, Ohio, United States
University of Toledo Medical Center
Toledo, Ohio, United States
Holy Spirit Hospital
Camp Hill, Pennsylvania, United States
South Carolina Heart Center
Columbia, South Carolina, United States
Greenville Hospital System
Greenville, South Carolina, United States
Holston Valley Hospital
Kingsport, Tennessee, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
12-004
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.