To evaluate the safety and effectiveness of the Spur System in a patient population with infrapopliteal artery disease (tibioperoneal, anterior/posterior tibial and peritoneal arteries) when used in conjunction with substance/drug coated balloons.
The objective of this study is to perform a prospective, multi-center (min 2 sites), non-randomized study to evaluate the safety and efficacy of the Spur system and compare treatments arms (if applicable) in treating subjects with infrapopliteal disease who are at risk for amputation. The study protocol will ensure consistency in performing the procedure, patient management and results of the procedure. Safety and efficacy will be evaluated during index procedure through one (1) year follow up
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
21
Treatment of infrapopliteal disease using SPUR/DCB, SPUR only and DCB alone
Instituto Nacional de la Diabetes (INDEN)
Santo Domingo, Dominican Republic
Demonstrate binary arterial flow at 6 months
The primary effectiveness endpoint assess arterial flow using duplex ultrasound at 6 months post procedure.
Time frame: 6 months
MALE
The secondary safety endpoint assess Freedom from Major Adverse Limb events (MALE) at 30 days
Time frame: 30 days
All cause perioperative death (30 days)
The secondary safety endpoint assess all-cause perioperative death (POD) at 30 days
Time frame: 30 days
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