The purpose of this trial is to evaluate the safety and efficacy of the Drug Eluting Temporary Spur Stent System compared to PTA.
The Drug Eluting Temporary Spur Stent System is intended for use as a primary treatment in the infrapopliteal arteries for the treatment of de novo or restenotic lesions.
Subject willing and able to provide informed consent and able to comply with the study protocol and follow up. Subjects who are unable to sign due to a physical limitation may have a Legally Authorized Representative (LAR), including a family member, sign on their behalf.
Life expectancy greater than 1 year in the investigator's opinion.
Subject is greater than 18 years of age.
Subjects must have chronic (greater than 14 days) symptoms of limb ischemia, determined by clinical symptoms of Rutherford class 4-5, rest pain (R4), and/or minor tissue loss (R5), that in the opinion of the investigator are not amenable to conservative medical therapy and require endovascular intervention for alleviation of symptoms and tissue preservation.
Subject unwilling or unlikely to comply with the 5-year duration of the study in the opinion of the investigator.
Subject is pregnant or planning to become pregnant during the course of the trial.
Subject is breastfeeding or planning to breastfeed 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.
Sequential
Drug Eluting Temporary Spur Stent System
DeviceThe Spur Stent consists of a sirolimus coated stent and balloon that is retrievable after delivery of the sirolimus formulation.
Percutaneous Transluminal Balloon Angioplasty
DeviceA balloon catheter is inserted across a lesion and inflated to fracture and compress the plaque, creating a larger lumen and improved blood flow through the artery.
Phase A: Primary Safety Endpoint
Freedom from the occurrence of major adverse limb events (MALE), and peri-operative death (POD), in Drug Eluting Temporary Spur Stent System and PTA-treated subjects through 30 days post-procedure. MALE are defined as: * Major amputation above the ankle * Major (open vascular surgery) reintervention * Target vessel thrombectomy or thrombolysis
Phase B: Primary Safety Endpoint
Freedom from the occurrence of POD at 30 days, and the occurrence of MALE at 6 months.
Phase B: Primary Efficacy Endpoint
Freedom from a composite endpoint of the occurrence of limb salvage and primary patency events at 6 months, defined as: * Clinically-driven target lesion revascularization (CD-TLR). * Above the ankle amputation in the index limb, in the presence of a totally occluded target vessel. * 100% total occlusion of target lesion in Spur and PTA-treated subjects.
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