A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo A… (NCT04144959) | Clinical Trial Compass
CompletedNot Applicable
A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo Aspiration System
United States119 participantsStarted 2019-12-17
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.