Clinical evaluation of the Thumbwheel Delivery Zilver PTX Drug-Eluting Peripheral Stent for Treatment of Lesions of the Above-the-Knee Femoropopliteal Artery

Completed

• Conditions: Peripheral Arterial Disease; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system

• Registration Number: ACTRN12614000504617
• Lead Sponsor: Cook Incorporated

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-05-13
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

A patient is deemed suitable for inclusion in the study if the patient meets the following criteria:

1. One atherosclerotic lesion of the above-the-knee femoropopliteal artery with >50% angiographically-documented stenosis
2. Reference vessel diameter of 4-7 mm
3. Symptomatic for peripheral arterial disease classified as Rutherford Category 2-4

Exclusion Criteria

Patients are excluded from enrollment into the study if any of the following are true:

General Exclusion Criteria
1. Unable or unwilling to sign and date informed consent
2. Less than 18 years of age
3. Unable or unwilling to comply with follow-up schedule
4. Simultaneous participation in another 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.
5. Pregnant, breastfeeding or planning to become pregnant in the next 5 years.
6. Medical condition or disorder that would limit life expectancy < 30 days
7. Prior stent in the study vessel
8. Underwent any surgical or interventional procedure within 30 days prior to the study procedure.
9. Planned surgical or interventional procedure within 30 days after the study procedure.
10. Contraindication to antiplatelet or anticoagulant medications
11. Known hypersensitivity or contraindication to study products (note: study products not limited to device materials, contrast, and antiplatelet or anticoagulant medications).
12. Unresolved systemic or local infection which could affect the clinical study outcomes.
13. Significant stenosis (>50%) or occlusion of inflow tract (proximal ipsilateral iliofemoral or aortic lesions) not successfully treated before this procedure (success is measured as < 30% residual stenosis).
14. Lacks at least one patent runoff vessel with < 50% stenosis; if runoff vessel is treated prior to the procedure the treatment must be successful with < 30% residual stenosis.
15. Untreated angiographically-evident thrombus in the target lesion.
16. Lesion requiring atherectomy (or ablative devices), cutting balloons, cryoplasty balloons, or any other advanced device to facilitate stent delivery.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Acute Effectiveness: Absolute mean change in stent length from pre- to post-deployment (less than 10%) measured angiographically. [At the time of the procedure.];Placement Accuracy: Determination of semi-quantitative placement accuracy based on a rating scale completed by the investigator.[At the time of the procedure. ];Acute Safety: Freedom from related death, amputation, and target lesion revascularisation (reintervention). [Through 30 days post-procedure.]

Secondary Outcome Measures

Name	Time	Method
Technical Success: Composite of optimal or acceptable placement accuracy and less than 10% stent length change upon deployment. [At the time of the procedure.]