Zilver® Flex™ Vascular Stent Study

Peripheral Arterial Disease (PAD) Clinical Trial

Official title:

Evaluation of the Zilver® Flex™ Vascular Stent in the Above-the-Knee Femoropopliteal Artery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00827619
• Other study ID #: 08-009
• Secondary ID: 100005, ZBLL
• Status: Completed
• Phase: N/A
• First received: January 22, 2009
• Last updated: December 3, 2015
• Start date: February 2009
• Est. completion date: November 2015

Study information

• Verified date: December 2015
• Source: Cook
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: November 2015
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Arterial Disease (PAD)
• Peripheral Vascular Diseases

Intervention

Device:
• Zilver® Flex™ Vascular Stent
Stenting of the Above-the-Knee Femoropopliteal Artery

Locations

Country	Name	City	State
Germany	Herz-Zentrum	Bad Krozingen
Germany	Gemeinschaftspraxis	Leipzig
Germany	Universitatsklinikum Magdeburg	Magdeburg

Sponsors (1)

Lead Sponsor	Collaborator
Cook

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary patency of the treated lesion within the superficial femoral artery		1 year after patient enrollment	No
Secondary	Procedural success and primary-assisted and secondary patency, thrombosis/total occlusion rate, clinical improvement, and functional status improvement		1 year after patient enrollment	No