Back to resultsZilver® PTX™ Global Registry
Primary Purpose
Peripheral Arterial Disease, Peripheral Vascular Disease
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Zilver® PTX™ Stent
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring Peripheral Aterial Disease (PAD), Peripheral Vascular Disease, Drug-Eluting Stent, Drug-Coated Stent, Vascular Diseases, Cardiovascular Diseases
Eligibility Criteria
Inclusion Criteria:
- stenosis of the above-the-knee femoropopliteal artery
- appropriate size and location of the lesion
Exclusion Criteria:
- pregnant or breast feeding
- failure or inability to give informed consent
- simultaneously participating in another drug or device study
Sites / Locations
- Heart Center Leipzig, Angiology
- St. Franziskus Hospital Munster
- Universitat Klinik Tubingen
- University of Roma La Sapienza
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Stent
Arm Description
Outcomes
Primary Outcome Measures
Event-free Survival
Secondary Outcome Measures
Full Information
NCT ID
NCT01094678
First Posted
March 25, 2010
Last Updated
September 9, 2014
Sponsor
Cook Group Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT01094678
Brief Title
Zilver® PTX™ Global Registry
Official Title
Evaluation of the Safety and Performance of the Zilver® PTX™ Drug-Eluting Stent for Treating De Novo or Restenotic Lesions of the Above-the-knee Femoropopliteal Artery
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cook Group Incorporated
4. Oversight
5. Study Description
Brief Summary
The Zilver PTX Registry Study is a prospective, non-randomized, open-label, multicenter single-arm study enrolling patients in Europe, Asia, and North America with de novo or restenotic (including in-stent restenosis) lesions of the above-the-knee femoropopliteal artery (SFA). The primary endpoint of the study is event-free survival (EFS) at 6 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease, Peripheral Vascular Disease
Keywords
Peripheral Aterial Disease (PAD), Peripheral Vascular Disease, Drug-Eluting Stent, Drug-Coated Stent, Vascular Diseases, Cardiovascular Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
788 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stent
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Zilver® PTX™ Stent
Intervention Description
Stenting of the superfemoropopliteal artery.
Primary Outcome Measure Information:
Title
Event-free Survival
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
stenosis of the above-the-knee femoropopliteal artery
appropriate size and location of the lesion
Exclusion Criteria:
pregnant or breast feeding
failure or inability to give informed consent
simultaneously participating in another drug or device study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Dake, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heart Center Leipzig, Angiology
City
Leipzig
ZIP/Postal Code
04289
Country
Germany
Facility Name
St. Franziskus Hospital Munster
City
Munster
ZIP/Postal Code
48145
Country
Germany
Facility Name
Universitat Klinik Tubingen
City
Tubingen
ZIP/Postal Code
72072
Country
Germany
Facility Name
University of Roma La Sapienza
City
Rome
ZIP/Postal Code
00161
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
33025243
Citation
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.
Results Reference
derived
PubMed Identifier
23583245
Citation
Dake 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. Erratum In: J Am Coll Cardiol. 2013 Aug 13;62(7):666.
Results Reference
derived
PubMed Identifier
23517839
Citation
Zeller T, Dake MD, Tepe G, Brechtel K, Noory E, Beschorner U, Kultgen PL, Rastan A. Treatment of femoropopliteal in-stent restenosis with paclitaxel-eluting stents. JACC Cardiovasc Interv. 2013 Mar;6(3):274-81. doi: 10.1016/j.jcin.2012.12.118.
Results Reference
derived
PubMed Identifier
21992630
Citation
Dake MD, Scheinert D, Tepe G, Tessarek J, Fanelli F, Bosiers M, Ruhlmann C, Kavteladze Z, Lottes AE, Ragheb AO, Zeller T; Zilver PTX Single-Arm Study Investigators. Nitinol stents with polymer-free paclitaxel coating for lesions in the superficial femoral and popliteal arteries above the knee: twelve-month safety and effectiveness results from the Zilver PTX single-arm clinical study. J Endovasc Ther. 2011 Oct;18(5):613-23. doi: 10.1583/11-3560.1.
Results Reference
derived
Learn more about this trial
Zilver® PTX™ Global Registry
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