Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Penumbra Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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)
You may not be if
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.
