Clinical Trial TitleA prospective single-arm multicenter study to evaluate the performance of the Bare Temporary Spur Stent System for the treatment of vascular lesions located in the infrapopliteal arteries below the knee
National Clinical Trial Number:NCT05358353
Clinical Trial Protocol Description:
This study uses the Bare Temporary Spur Stent System as a temporary endovascular stent integrated with a balloon catheter intended for use as primary treatment of the Infrapopliteal arteries for patients with critical limb ischemia. This study is intended for patients with infrapopliteal CLI, Rutherford class 4 or 5. The duration of the study is approximately 12 months.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Present with chronic symptoms of limb ischemia, determined by Rutherford class 4-5 requiring endovascular intervention.
- Have presence of stenotic, restenotic, or occlusive lesions in the infrapopliteal vessels per angiogram.
You will be excluded from the study if any of the following criteria apply to you:
- Have a wound not confined to the foot below the ankle (heel wounds excluded).
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.