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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.
ClinicalTrials.gov Identifier: NCT00827619
Recruitment Status : Completed
First Posted : January 23, 2009
Last Update Posted : December 4, 2015
Sponsor:
Information provided by (Responsible Party):
Cook Group Incorporated

Brief Summary:
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 or disease Intervention/treatment
Peripheral Arterial Disease (PAD) Device: Zilver® Flex™ Vascular Stent

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
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
Study Start Date : February 2009
Primary Completion Date : November 2011
Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
1
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



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

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00827619


Locations
Germany
Herz-Zentrum
Bad Krozingen, Germany, 79189
Gemeinschaftspraxis
Leipzig, Germany, 04177
Universitatsklinikum Magdeburg
Magdeburg, Germany, 39120
Sponsors and Collaborators
Cook Group Incorporated
Investigators
Principal Investigator: Jens Ricke, MD Universitatsklinikum Magdeburg

Responsible Party: Cook Group Incorporated
ClinicalTrials.gov Identifier: NCT00827619     History of Changes
Other Study ID Numbers: 08-009
100005, ZBLL
First Posted: January 23, 2009    Key Record Dates
Last Update Posted: December 4, 2015
Last Verified: December 2015

Keywords provided by Cook Group Incorporated:
Peripheral Arterial Disease

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases