Evaluation of the Zilver PTX Drug-Eluting Stent in the Above-the-Knee Femoropopliteal Artery
Zilver PTX
2 other identifiers
interventional
474
3 countries
52
Brief Summary
The Zilver® PTX™ Drug Eluting Vascular Stent is indicated for the treatment of symptomatic vascular disease of the above-the-knee femoropopliteal artery (ranging from 4 mm to 9 mm in reference vessel diameter) for lesions up to 7 cm long. The clinical trial is stratified by lesion length. The trial will be conducted in 2 phases, with Phase 1 enrolling patients with lesions less than 7 cm long. Phase 2 of the trial will include longer lesions (up to 14 cm long) and will be initiated upon approval by the Food and Drug Administration (FDA).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2005
Longer than P75 for not_applicable
52 active sites
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
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
July 11, 2005
CompletedFirst Posted
Study publicly available on registry
July 18, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedResults Posted
Study results publicly available
August 11, 2014
CompletedAugust 11, 2014
July 1, 2014
4.6 years
July 11, 2005
February 5, 2014
July 21, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Event-free Survival Rate
Event-free survival is defined as freedom from the major adverse events of death, target lesion revascularization, target limb ischemia requiring surgical intervention (bypass or amputation of toe, foot or leg), surgical repair of the target vessel (e.g., dissection requiring surgery), and from worsening of the Rutherford classification by 2 classes or to class 5 or 6. Participant flow is based on initial randomization of Zilver PTX or PTA (Percutaneous balloon angioplasty), and Event-free survival is based on Per-Protocol analysis where only patients who were treated according to their initial randomization are counted.
12 months
Primary Patency
Primary patency is defined as a Peak systolic velocity (PSV) ratio \< 2.0 or angiographic percent diameter stenosis \< 50%.
12 months
Study Arms (2)
1
EXPERIMENTALZilver® PTX™ Drug Eluting Vascular Stent
2
ACTIVE COMPARATORAngioplasty
Interventions
Eligibility Criteria
You may qualify if:
- Patient has signed and dated the informed consent.
You may not qualify if:
- Patient has a de novo or restenotic lesion(s) with \>50% stenosis documented angiographically and no prior stent in the target lesion.
- Patient has symptoms of peripheral arterial disease classified as Rutherford Category 2 or greater.
- Patient has a resting Ankle Brachial Index (ABI) \<0.9 or an abnormal exercise ABI if resting ABI is normal. Patient with incompressible arteries (ABI \>1.2) must have a Toe Brachial Index (TBI) \<0.8.
- Patient agrees to return for a clinical status assessment and duplex ultrasound at 6 months, 12 months, and at 2, 3, 4, and 5 years.
- Patient agrees to return for x-rays at 6 and 12 months.
- Patient agrees to return for angiography at 12 months.
- Patient agrees to be contacted by telephone at 1, 3, 9, and 18 months to assess clinical status.
- Patient is pregnant or breast-feeding.
- Patient is simultaneously participating in another investigational drug or device study.
- Patient has significant stenosis or occlusion of inflow tract not successfully treated before this procedure.
- Patient has any planned surgical or interventional procedure within 30 days after the study procedure.
- Patient has had previous stenting of target vessel.
- Patient in whom antiplatelet and/or anticoagulant therapy is contraindicated.
- Patient has known hypersensitivity or contraindication to aspirin, antiplatelet medication, contrast dye, paclitaxel or nitinol and, in the opinion of the investigator, cannot be adequately premedicated.
- Patient lacks at least one patent vessel of runoff with \<50% stenosis throughout its course.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cook Group Incorporatedlead
- William Cook Europecollaborator
- MED Institute, Incorporatedcollaborator
- Cook Japan Incorporatedcollaborator
Study Sites (52)
El Camino Hospital
Mountain View, California, 94040, United States
Tri-City Medical Center
Oceanside, California, 92056, United States
Stanford University Hospital and Clinics
Stanford, California, 94305, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
JFK Memorial Center
Atlantis, Florida, 33462, United States
University of Florida
Gainesville, Florida, 32610, United States
Memorial -- Jacksonville
Jacksonville, Florida, 32216, United States
Baptist Cardiac & Vascular Institute
Miami, Florida, 33176, United States
Orlando Regional Medical Center
Orlando, Florida, 32806, United States
Piedmont Hospital
Atlanta, Georgia, 30309, United States
OSF St. Francis Medical Center
Peoria, Illinois, 61637, United States
Prairie Heart
Springfield, Illinois, 62702, United States
St. Vincent Hospital
Indianapolis, Indiana, 46260, United States
The Care Group
Indianapolis, Indiana, 46290, United States
Christus St. Patrick Hospital
Lake Charles, Louisiana, 70601, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Bayview Medical Center
Baltimore, Maryland, 21224, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Michigan Vascular Research Center
Flint, Michigan, 48507, United States
William Beaumont
Royal Oak, Michigan, 48073, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
St. Luke's Hospital Kansas
Kansas City, Missouri, 64111, United States
NYU Medical Center
New York, New York, 10016, United States
St. Luke's Roosevelt Hospital Center
New York, New York, 10025, United States
New York Presbyterian Hospital
New York, New York, 10032, United States
Lenox Hill
New York, New York, 10075, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Carolinas Medical Center
Charlotte, North Carolina, 28203, United States
Good Samaritan Hospital
Cincinnati, Ohio, 45220, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
MidWest Cardiology Research Foundation
Columbus, Ohio, 43214, United States
EMH Regional Medical Center
Elyria, Ohio, 44035, United States
University of Toledo University Medical Center
Toledo, Ohio, 43614, United States
Pinnacle Health Harrisburg
Harrisburg, Pennsylvania, 17110, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224, United States
South Carolina Heart Center
Columbia, South Carolina, 92904, United States
Greenville Memorial Hospital
Greenville, South Carolina, 29605, United States
Methodist Hospital
Houston, Texas, 77030, United States
Peripheral Vascular Associates (PVA)
San Antonio, Texas, 78229, United States
LDS
Murray, Utah, 84107, United States
University of Virginia Medical Center
Charlottesville, Virginia, 22908, United States
St. Luke's Hospital
Milwaukee, Wisconsin, 53215, United States
Herz-Zentrum
Bad Krozingen, 79189, Germany
Gemeinschaftspraxis
Leipzig, 04177, Germany
Heart Center Leipzig, Angiology
Leipzig, 04289, Germany
Universitatsklinikum Magdeburg
Magdeburg, 39120, Germany
Kokura Memorial Hospital
Kitakyushu, Fukuoka, 802-8555, Japan
The Jikei University Hospital
Nishi-Shinbashi, Minato-ku, Japan
Kyoto University Hospital
Kyoto, 606-8507, Japan
Nara Medical University
Nara, 634-8522, Japan
Related Publications (5)
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.
PMID: 33025243DERIVEDDake MD, Ansel GM, Jaff MR, Ohki T, Saxon RR, Smouse HB, Machan LS, Snyder SA, O'Leary EE, Ragheb AO, Zeller T; Zilver PTX Investigators. Durable Clinical Effectiveness With Paclitaxel-Eluting Stents in the Femoropopliteal Artery: 5-Year Results of the Zilver PTX Randomized Trial. Circulation. 2016 Apr 12;133(15):1472-83; discussion 1483. doi: 10.1161/CIRCULATIONAHA.115.016900. Epub 2016 Mar 11.
PMID: 26969758DERIVEDOhki T, Yokoi H, Kichikawa K, Kimura T, Snyder SA, Ragheb AO, O'Leary EE, Jaff MR, Ansel GM, Dake MD. Two-year analysis of the Japanese cohort from the Zilver PTX randomized controlled trial supports the validity of multinational clinical trials. J Endovasc Ther. 2014 Oct;21(5):644-53. doi: 10.1583/14-4753.1.
PMID: 25290792DERIVEDDake MD, Ansel GM, Jaff MR, Ohki T, Saxon RR, Smouse HB, Snyder SA, O'Leary EE, Tepe G, Scheinert D, Zeller T; Zilver PTX Investigators. Sustained safety and effectiveness of paclitaxel-eluting stents for femoropopliteal lesions: 2-year follow-up from the Zilver PTX randomized and single-arm clinical studies. J Am Coll Cardiol. 2013 Jun 18;61(24):2417-2427. doi: 10.1016/j.jacc.2013.03.034. Epub 2013 Apr 10.
PMID: 23583245DERIVEDDake MD, Ansel GM, Jaff MR, Ohki T, Saxon RR, Smouse HB, Zeller T, Roubin GS, Burket MW, Khatib Y, Snyder SA, Ragheb AO, White JK, Machan LS; Zilver PTX Investigators. Paclitaxel-eluting stents show superiority to balloon angioplasty and bare metal stents in femoropopliteal disease: twelve-month Zilver PTX randomized study results. Circ Cardiovasc Interv. 2011 Oct 1;4(5):495-504. doi: 10.1161/CIRCINTERVENTIONS.111.962324. Epub 2011 Sep 27.
PMID: 21953370DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Scott Snyder, PhD, Director of Clinical Science and Biostatistics
- Organization
- Cook
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Dake, M.D.
Stanford University
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 11, 2005
First Posted
July 18, 2005
Study Start
March 1, 2005
Primary Completion
October 1, 2009
Study Completion
February 1, 2014
Last Updated
August 11, 2014
Results First Posted
August 11, 2014
Record last verified: 2014-07