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.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease (PAD)
• Intervention / Treatment: Device: Zilver® Flex™ Vascular Stent

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bad Krozingen, Germany, 79189
    • Herz-Zentrum
  • Leipzig, Germany, 04177
    • Gemeinschaftspraxis
  • Magdeburg, Germany, 39120
    • Universitätsklinikum Magdeburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 1; single arm non-randomized post-market study	Device: Zilver® Flex™ Vascular Stent; Stenting of the Above-the-Knee Femoropopliteal Artery; Other Names: Implant; Stenting; Vascular Stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Primary patency of the treated lesion within the superficial femoral artery	1 year after patient enrollment

Secondary Outcome Measures

Outcome Measure	Time Frame
Procedural success and primary-assisted and secondary patency, thrombosis/total occlusion rate, clinical improvement, and functional status improvement	1 year after patient enrollment

Collaborators and Investigators

• Sponsor: Cook Group Incorporated
• Investigators: Principal Investigator: Jens Ricke, MD, Universitätsklinikum Magdeburg

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: January 22, 2009
• First Submitted That Met QC Criteria: January 22, 2009
• First Posted (Estimate): January 23, 2009

Study Record Updates

• Last Update Posted (Estimate): December 4, 2015
• Last Update Submitted That Met QC Criteria: December 3, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Peripheral Arterial Disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: 08-009 (Caen, Hospital); 100005, ZBLL