N/A
N=119
A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo Aspiration System
Lower Extremity Acute Limb Ischemia · LE ALI
Bottom Line
View on ClinicalTrials.gov: NCT04144959 ↗Enrolled (actual)
119
Serious AEs
75.6%
Results posted
Jun 2025
Primary outcome: Primary: Target Limb Salvage Rate — 109 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Indigo Aspiration System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Penumbra Inc.
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Target Limb Salvage Rate |
72 | — |
| SECONDARY Technical Success |
105 | — |
| SECONDARY Modified Society for Vascular Surgery Runoff Score |
6.3 | — |
| SECONDARY Improvement of Rutherford Classification |
83 | — |
| SECONDARY Vessel Patency |
101 | — |
| SECONDARY Target Limb Salvage Rate |
72 | — |
| SECONDARY Rates of Device Related Serious Adverse Events (SAEs) |
1 | — |
| SECONDARY Major Bleeding Peri-procedure |
5 | — |
| SECONDARY Mortality |
12 | — |
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).
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04144959). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.