Zilver® Flex™ Vascular Stent Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT00827619
First received: January 22, 2009
Last updated: September 4, 2014
Last verified: September 2014
  Purpose

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: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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:

Primary Outcome Measures:
  • Primary patency of the treated lesion within the superficial femoral artery [ Time Frame: 1 year after patient enrollment ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Enrollment: 110
Study Start Date: February 2009
Estimated Study Completion Date: November 2015
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  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 ClinicalTrials.gov identifier: NCT00827619

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

No publications provided

Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT00827619     History of Changes
Other Study ID Numbers: 08-009, 100005, ZBLL
Study First Received: January 22, 2009
Last Updated: September 4, 2014
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by Cook:
Peripheral Arterial Disease

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

ClinicalTrials.gov processed this record on September 30, 2014