A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo Aspiration System

STRIDE: A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo Aspiration System

The primary objective of this study is to collect safety and performance data on the Indigo Aspiration System in a patient population with lower extremity acute limb ischemia (LE ALI).

Inclusion Criteria:

• Patient age ≥ 18
• Patient presents with acute (≤14 days) occlusion of lower limb artery(ies) (below inguinal ligament)
• Patient with a Rutherford Category I, IIa or IIb score
• Frontline treatment with Indigo Aspiration System
• Informed consent is obtained from either patient or legally authorized representative (LAR)

Exclusion Criteria:

• Life expectancy <1 year
• Vessel size <2 mm
• LE ALI secondary to dissections, vasculitis, and/or target vessel trauma
• Amputation in the ipsilateral limb
• Pregnancy or positive pregnancy test according to site specific standards of care (only required for women of child bearing potential, serum or urine acceptable)
• Absolute contraindication to contrast administration
• Patient is unwilling or unable to comply with protocol follow up schedule and/or based on the Investigator's judgment the patient is not a good study candidate
• Currently participating in an investigational drug or device clinical trial that may confound the study endpoints. Patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible.