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

Completed

Conditions: Lower Extremity Acute Limb Ischemia
LE ALI

Registration Number: NCT04144959

Lead Sponsor: Penumbra Inc.

Brief 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).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 119

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.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Target Limb Salvage Rate	1-Month Post Procedure	Proportion of participants who did not have a major amputation (above the level of the tarsometatarsal joint)

Secondary Outcome Measures

Name	Time	Method
Technical Success	Immediate Post Procedure	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.
Modified Society for Vascular Surgery Runoff Score	Pre Procedure and immediately Post Procedure	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
Improvement of Rutherford Classification	Up to discharge or 7 days, whichever occurred first	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
Vessel Patency	1-Month Post-Procedure	Patency is defined as a target lesion without a hemodynamically significant stenosis /reocclusion on duplex ultrasound (\>50 %, ) and without target lesion reintervention (TLR ).
Target Limb Salvage Rate	12-Months Post Procedure	Proportion of participants who did not have a major amputation (above the level of the tarsometatarsal joint)
Rates of Device Related Serious Adverse Events (SAEs)	Up until study completion, at approximately 12-Months	A SAE is an event that led to death, led to a serious deterioration in the health of the patient that resulted in life-threatening illness or injury, resulted in chronic disease, resulted in permanent impairment of a body structure or a body function, required in-patient hospitalization or prolongation of existing hospitalization, resulted in medical or surgical intervention to arrest permanent impairment to body structure or a body function, led to fetal distress, fetal death or a congenital abnormality or birth defect
Major Bleeding Peri-procedure	within 2 days of procedure	Fatal or leading to a drop in hemoglobin of ≥5 g /dl, or significant hypotension with the need for inotropes, or requiring surgery (other than vascular site repair ), or symptomatic intracranial hemorrhage (ICH ), or requiring transfusion of two or three units of red blood cells or equivalent whole blood
Mortality	12-Months	Death due to any cause

Trial Locations

Locations (17): Trihealth Good Samaritan Hospital of Cincinnati
🇺🇸
Cincinnati, Ohio, United States
Stanford University Medical Center
🇺🇸
Stanford, California, United States
Danbury Hospital
🇺🇸
Danbury, Connecticut, United States
Manatee Memorial Hospital
🇺🇸
Bradenton, Florida, United States
Baptist Hospital of Miami
🇺🇸
Miami, Florida, United States
University of Maryland
🇺🇸
Baltimore, Maryland, United States
Albany Medical Center
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Albany, New York, United States
Tisch Hospital NYU Langone Health
🇺🇸
New York, New York, United States
NC Heart and Vascular Research
🇺🇸
Cary, North Carolina, United States
Sanger Heart & Vascular Institute
🇺🇸
Charlotte, North Carolina, United States
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Trihealth Good Samaritan Hospital of Cincinnati
🇺🇸Cincinnati, Ohio, United States