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

Study Overview
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Brief Summary
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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).

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

Conditions
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Lower Extremity Acute Limb Ischemia, LE ALI

Intervention / Treatment
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* Device: Indigo Aspiration System


Participation Criteria
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Eligibility Criteria
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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 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with lower extremity acute limb ischemia<br> | Device: Indigo Aspiration System<br>* Indigo Aspiration System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target limb salvage rate |  | 1-Month Post Procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical Success | Defined as TIMI 2/3 flow rate TIMI flow grading range 1-3, with higher grading representing better outcome | Immediate Post Procedure | 
| Modified SVS runoff score | Immediate Post Procedure as compared to Baseline Modified SVS runoff score ranges from 0-19, with a higher score indicating more severe disease | Immediate Post Procedure | 
| Improvement of Rutherford classification | Improvement of one or more as compared to pre-procedure Rutherford classification ranges from I-III, with a higher score representing worse outcomes | Up until study completion, at approximately 12-Months | 
| Vessel Patency |  | 1-Month Post-Procedure | 
| Target limb salvage rate |  | 12-Months Post Procedure | 
| Rates of device related serious adverse events (SAEs) |  | Up until study completion, at approximately 12-Months | 
| Major bleeding peri-procedure |  | During procedure | 
| Mortality |  | 12-Months |