The primary objective of this study is to collect and evaluate clinical evidence supporting the safety and performance of the Indigo™ Aspiration System in a patient population with lower extremity acute limb ischemia (LE ALI).
Study Type
OBSERVATIONAL
Enrollment
300
Mechanical aspiration thrombectomy with the Indigo Aspiration System.
HonorHealth Scottsdale Osborn Medical Center
Target Limb Salvage Rate
Time frame: 30 Days Post-Procedure
Technical Success
Technical success defined as Thromboaspiration in Peripheral Ischemia (TIPI) 2/3 flow immediately post procedure by physician visual assessment of intraprocedural angiography
Time frame: Immediate Post Procedure
Primary Patency at 30 Days
Time frame: 30 Days Post-Procedure
Rates of Device-related Major Bleeding
Time frame: Procedure, 30 Days, and 180 Days Post-Procedure
Rates of Device-related Distal Embolization
Time frame: During Procedure
Rates of Device-related Serious Adverse Events (SAE)
Time frame: Procedure, 30 Days, and 180 Days Post-Procedure
Mortality
All cause mortality at 30 and 180 days
Time frame: 30 Days and 180 Days Post-Procedure
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