This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Zilver® Flex™ Vascular Stent Study

This study has been completed.
Information provided by (Responsible Party):
Cook Group Incorporated Identifier:
First received: January 22, 2009
Last updated: December 3, 2015
Last verified: December 2015
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.

Condition Intervention
Peripheral Arterial Disease (PAD) Device: Zilver® Flex™ Vascular Stent

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Zilver® Flex™ Vascular Stent in the Above-the-Knee Femoropopliteal Artery

Resource links provided by NLM:

Further study details as provided by Cook Group Incorporated:

Primary Outcome Measures:
  • Primary patency of the treated lesion within the superficial femoral artery [ Time Frame: 1 year after patient enrollment ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 110
Study Start Date: February 2009
Study Completion Date: November 2015
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
single arm non-randomized post-market study
Device: Zilver® Flex™ Vascular Stent
Stenting of the Above-the-Knee Femoropopliteal Artery
Other Names:
  • Stenting
  • Vascular Stent
  • Implant


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00827619

Bad Krozingen, Germany, 79189
Leipzig, Germany, 04177
Universitatsklinikum Magdeburg
Magdeburg, Germany, 39120
Sponsors and Collaborators
Cook Group Incorporated
Principal Investigator: Jens Ricke, MD Universitatsklinikum Magdeburg
  More Information

Responsible Party: Cook Group Incorporated Identifier: NCT00827619     History of Changes
Other Study ID Numbers: 08-009
100005, ZBLL
Study First Received: January 22, 2009
Last Updated: December 3, 2015

Keywords provided by Cook Group Incorporated:
Peripheral Arterial Disease

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases processed this record on August 18, 2017