Zilver® Flex™ Vascular Stent Study

NCT00827619 | Completed

• 2 other identifiers: 08-009100005, ZBLL
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 3

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.

Conditions

Peripheral Arterial Disease (PAD)

Keywords

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• Primary patency of the treated lesion within the superficial femoral artery

  1 year after patient enrollment

Secondary Outcomes (1)

• Procedural success and primary-assisted and secondary patency, thrombosis/total occlusion rate, clinical improvement, and functional status improvement

  1 year after patient enrollment

Study Arms (1)

1

OTHER

single arm non-randomized post-market study

Device: Zilver® Flex™ Vascular Stent

Interventions

Zilver® Flex™ Vascular Stent DEVICE

Stenting of the Above-the-Knee Femoropopliteal Artery

Also known as: Stenting, Vascular Stent, Implant

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cook Group Incorporated: lead

Study Sites (3)

Herz-Zentrum

Bad Krozingen, 79189, Germany

Location

Gemeinschaftspraxis

Leipzig, 04177, Germany

Location

Universitatsklinikum Magdeburg

Magdeburg, 39120, Germany

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Stents; Mutagenesis, Insertional

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies; Protein Engineering; Genetic Engineering; Genetic Techniques; Investigative Techniques; Mutation; Genetic Variation; Genetic Phenomena; Mutagenesis

Study Officials

• Jens Ricke, MD

  Universitatsklinikum Magdeburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2009
• First Posted: January 23, 2009
• Study Start: February 1, 2009
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2015
• Last Updated: December 4, 2015

Record last verified: 2015-12

Locations

DE (3)