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

Penumbra Inc.119 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

119

Conditions

Lower Extremity Acute Limb Ischemia LE ALI

Interventions

Indigo Aspiration SystemDEVICE

Indigo Aspiration System

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (17)

Stanford University Medical Center

Stanford, California, United States

Danbury Hospital

Danbury, Connecticut, United States

Outcomes

Primary Outcomes

Target Limb Salvage Rate

Proportion of participants who did not have a major amputation (above the level of the tarsometatarsal joint)

Time frame: 1-Month Post Procedure

Secondary Outcomes

Technical Success

Defined as TIMI 2/3 flow rate TIMI flow grade: Grade 0 No perfusion Grade 1 Perfusion past initial occlusion but no distal branch filling. Grade 2 Perfusion with incomplete or slow distal branch filling. Grade 3 Full perfusion with filling of all distal branches.

Time frame: Immediate Post Procedure

Modified Society for Vascular Surgery Runoff Score

Endpoint is change in modified SVS Runoff Score at post-procedure Modified SVS runoff score ranges from 1-19, with a higher score indicating more severe disease

Time frame: Pre Procedure and immediately Post Procedure

Improvement of Rutherford Classification

Improvement of one or more as compared to pre-procedure Rutherford classification: I.Viable Not immediately threatened IIa.Threatened Marginally Salvageable if promptly treated IIb. Threatened Immediately Salvageable with immediate revascularization III. Irreversible

Time frame: Up to discharge or 7 days, whichever occurred first

Vessel Patency

Patency is defined as a target lesion without a hemodynamically significant stenosis /reocclusion on duplex ultrasound (\>50 %, ) and without target lesion reintervention (TLR ).

Time frame: 1-Month Post-Procedure

Target Limb Salvage Rate

Proportion of participants who did not have a major amputation (above the level of the tarsometatarsal joint)

Time frame: 12-Months Post Procedure

Data from ClinicalTrials.gov

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