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

  • STATUS
    Recruiting
  • End date
    Dec 4, 2023
  • participants needed
    130
  • sponsor
    Penumbra Inc.
Updated on 4 October 2020
Investigator
Ella Reyes
Primary Contact
University of Maryland (2.8 mi away) Contact
+10 other location

Summary

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).

Details
Treatment Indigo Aspiration System
Clinical Study IdentifierNCT04144959
SponsorPenumbra Inc.
Last Modified on4 October 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: LE ALI or Lower Extremity Acute Limb Ischemia?
Patient age 18
Patient presents with acute (14 days) occlusion of lower limb artery(ies) (below inguinal ligament)
Patient with a Rutherford Category 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
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