Zilver® Flex™ Vascular Stent Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00827619
Recruitment Status : Completed
First Posted : January 23, 2009
Last Update Posted : December 4, 2015
Information provided by (Responsible Party):
Cook Group Incorporated

January 22, 2009
January 23, 2009
December 4, 2015
February 2009
November 2011   (Final data collection date for primary outcome measure)
Primary patency of the treated lesion within the superficial femoral artery [ Time Frame: 1 year after patient enrollment ]
Same as current
Complete list of historical versions of study NCT00827619 on Archive Site
Procedural success and primary-assisted and secondary patency, thrombosis/total occlusion rate, clinical improvement, and functional status improvement [ Time Frame: 1 year after patient enrollment ]
Same as current
Not Provided
Not Provided
Zilver® Flex™ Vascular Stent Study
Evaluation of the Zilver® Flex™ Vascular Stent in the Above-the-Knee Femoropopliteal Artery
This study is intended to evaluate the long-term effectiveness of treatment of de novo or restenotic lesions of the above-the-knee femoropopliteal artery using the Zilver® Flex™ Vascular Stent which has received the CE mark for commercial use. The study is designed as a single arm non-randomized post-approval study.
Not Provided
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Peripheral Arterial Disease (PAD)
Device: Zilver® Flex™ Vascular Stent
Stenting of the Above-the-Knee Femoropopliteal Artery
Other Names:
  • Stenting
  • Vascular Stent
  • Implant
single arm non-randomized post-market study
Intervention: Device: Zilver® Flex™ Vascular Stent
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
November 2015
November 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients who are at least 18 years old and have at least 1 stenotic atherosclerotic lesion of the above-the-knee femoropopliteal artery may be considered for enrollment.
  • To be enrolled in the study, the lesion must be the appropriate size and and no prior stent in the target vessel may be present.

Exclusion Criteria:

  • Patient is < 18 years of age.
  • Patient is pregnant or breast-feeding.
  • Patient is simultaneously participating in an investigational drug or device study. The patient must have completed the follow-up phase for the primary endpoint of any previous study at least 30 days prior to enrollment in this study.
  • Patient has had previous stenting of the target vessel.
  • Patient has a medical condition or disorder that would limit life expectancy to less than 1 year or that may cause noncompliance with the protocol or confound the data analysis.
  • Patient in whom antiplatelet and/or anticoagulant therapy is contraindicated.
  • Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
  • Patient has known hypersensitivity or contraindication to aspirin, antiplatelet medication, contrast dye, or nitinol that, in the opinion of the investigator, cannot be adequately premedicated.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
France,   Spain
100005, ZBLL
Not Provided
Not Provided
Not Provided
Cook Group Incorporated
Cook Group Incorporated
Not Provided
Principal Investigator: Jens Ricke, MD Universitatsklinikum Magdeburg
Cook Group Incorporated
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP