Feasibility Clinical Trial Using the SPUR System to Demonstrate Safety and Efficacy. (DEEPER)

This is an interventional device feasibility trial for Critical Limb Ischemia Read More

Inclusion Criteria:

• Patient is willing and able to provide informed consent and able to comply with the study protocol.
• Peripheral arterial disease that can be treated using PTA.
• Life expectancy >1 year in the investigator's opinion
• Male or non-pregnant female > 18 years of age
• Patent inflow artery
• Target vessel(s) reconstitutes(s) at or above the ankle, excluding the dorsalis pedis and the calcaneal branch of the posterior tibial artery
• Target lesion starts at or below 3 cm below the tibial plateau as measured by angiography
• Target vessel for Spur device is ≥ 3.5 mm (4mm); ≥ 2.5 mm (3mm) in diameter by visual estimate.
• Lesion(s) must be able to be treated with a minimum of one Spur or PTA or DCB product.
• Infrapopliteal lesion(s) that are located in either the left or right leg Infrapopliteal artery(s) may be treated with only one modality per artery: DCB, Spur or Spur/DCB.
• Arterial length/diameter and quantity must be able to be treated with DCB or Spur or Spur/DCB
• The treated segment is defined as the total length of artery treated with PTA.
• The cumulative treated segment of infrapopliteal artery(s) must be ≤34.0 cm.
• Lesions in the treated segment may be continuous or may have gaps present between stenosis or occlusions
• Patient has Rutherford Classification of 3-5.
• Successful pre-dilatation of the target lesion.
• Iliac, SFA and popliteal inflow lesions can be treated during the same procedure using standard angioplasty and/or approved device. These inflow lesions must be treated first, prior to consideration of treatment of infrapopliteal lesions.
• The patient can be enrolled if the inflow lesions have acceptable angiographic results (must have <30% residual stenosis and no evidence of embolization or flow limiting dissection)

Exclusion Criteria:

• Subject unwilling or unlikely to comply with the appropriate follow up time for the duration of the study
• Prior stent(s) or bypass surgery within the target vessel(s)
• Target lesion is located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion.
• Previous treatment failure of inflow arteries (Iliac, SFA and popliteal) which required a surgical procedure.
• Previous PTA of the target vessel within 30 day prior to index procedure
• Angiographic evidence of thrombus within target limb.
• Subject has an active infection of the foot, including pus or wet gangrene that is not controlled at the time of the procedure.
• Planned major (above the ankle) amputation of the target limb
• Recent MI or stroke < 30 days prior to the index procedure.
• Heart failure with Ejection Fraction < 30%
• Impaired renal function (GFR <30 mL/min) and patients on dialysis
• Subject with vasculitis, systemic Lupus Erythematosus or Polymyalgia Rheumatica.
• Patient receiving systemic corticosteroid therapy.
• Inability to tolerate concomitant antiplatelet and oral anticoagulation therapy.
• Known allergies or sensitivities to heparin, aspirin (ASA), other anticoagulant therapies which could not be substituted, and/or paclitaxel or an allergy to contrast media that cannot be adequately pre-treated prior to the index procedure.
• The patient is currently enrolled in another investigational device or drug trial that is interfering with the endpoints of this study.