IRB Study Number 23-220
Status Recruiting
Location Cleveland Clinic Main Campus
Institute Heart and Vascular Institute
Description
This study is a prospective, multicenter, single arm study design to evaluate the safety and efficacy of the Temporary Bare Spur Stent System (Spur Stent System) compared to the percutaneous transluminal balloon angioplasty (PTA). The stent system is intended for use in the infrapopliteal arteries ranging in diameter from 2.5 mm to 4.5 mm for the treatment of the critical limb ischemia (CLI).
Inclusion Criteria
- Subject willing and able to provide informed consent and able to comply with the study protocol and follow up.
- Life expectancy greater than 1 year in the investigator's opinion.
- Male or non-pregnant female ≥ 18 years of age at the time of consent.
- Subjects must have chronic symptoms of limb ischemia, determined by clinical symptoms of Rutherford class 4-5, rest pain, and/or minor tissue loss.
Exclusion Criteria
- Subject is unwilling to comply with the 1-year duration of the study.
- Subject is pregnant or planning to become pregnant during the course of the trial.
- Subject has an active systemic infection that is not controlled at the time of the procedure, including septicemia or bacteremia.
- Heel wounds.
- Planned major amputation of the target limb.
- Known allergy to nitinol or nickel.
- Subject is currently enrolled in another investigational device or drug trial that interferes with the study endpoints.
