None listed
Conditions
Brief summary
The purpose of this study is to evaluate the performance and safety of a new delivery system for the Zilver PTX Drug-Eluting Peripheral Stent in the treatment of peripheral arterial disease.
Interventions
The purpose of this study is to evaluate a new delivery system for the Zilver PTX (paclitaxel) Drug-Eluting Peripheral Stent. The Zilver PTX Drug-Eluting Peripheral Stent has been approved for use in Australia and New Zealand since 2011. However, this study aims to investigate the performance and safety of a new system (known as a thumbwheel) for delivering the stent to the narrowing in the artery.
The current Zilver PTX Stent has a pin and pull delivery system which requires the doctor to us
The purpose of this study is to evaluate a new delivery system for the Zilver PTX (paclitaxel) Drug-Eluting Peripheral Stent. The Zilver PTX Drug-Eluting Peripheral Stent has been approved for use in Australia and New Zealand since 2011. However, this study aims to investigate the performance and safety of a new system (known as a thumbwheel) for delivering the stent to the narrowing in the artery. The current Zilver PTX Stent has a pin and pull delivery system which requires the doctor to use two hands to pull back the outer covering of the stent, whereas the thumbwheel system only requires the doctor to use one hand. The handle is made to fit comfortably in one hand and a wheel on the top part of the handle is rotated using the thumb. By rotating the wheel the cover is pulled back off the stent and the stent self-expands into the blood vessel. The thumbwheel system is expected to make it easier for the doctor to use. A single arterial segment within the above-the-knee femoropopliteal artery will be treated per patient; the treated segment will include one de novo or restenosed artherosclerotic lesion with > 50% angiographically-documented diameter stenosis. One or more Zilver PTX stents will be used to treat the study lesion and angiography will be performed during the procedure. The amount of paclitaxel delivered by the stent is 3 micrograms/mm2. Pre- and post-stent dilatation using a standard percutaneous transluminal angioplasty balloon may also be performed. The procedure will take approximately 1-2 hours. A follow-up assessment of symptoms, medications and adverse events will be performed at one month post-procedure.
Sponsors
Cook Incorporated
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed