A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo Aspiration System
- Conditions
- Lower Extremity Acute Limb IschemiaLE ALI
- Interventions
- Device: Indigo Aspiration System
- 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
- 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)
- 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
- Arm && Interventions
Group Intervention Description Patients with lower extremity acute limb ischemia Indigo Aspiration System -
- Primary Outcome Measures
Name Time Method Target limb salvage rate 1-Month Post Procedure
- Secondary Outcome Measures
Name Time Method Modified SVS runoff score Immediate Post Procedure Immediate Post Procedure as compared to Baseline
Modified SVS runoff score ranges from 0-19, with a higher score indicating more severe diseaseTechnical Success Immediate Post Procedure Defined as TIMI 2/3 flow rate
TIMI flow grading range 1-3, with higher grading representing better outcomeImprovement of Rutherford classification Up until study completion, at approximately 12-Months Improvement of one or more as compared to pre-procedure
Rutherford classification ranges from I-III, with a higher score representing worse outcomesVessel Patency 1-Month Post-Procedure Target limb salvage rate 12-Months Post Procedure Major bleeding peri-procedure During procedure Rates of device related serious adverse events (SAEs) Up until study completion, at approximately 12-Months Mortality 12-Months
Trial Locations
- Locations (17)
Manatee Memorial Hospital
🇺🇸Bradenton, Florida, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
Albany Medical Center
🇺🇸Albany, New York, United States
NC Heart and Vascular Research
🇺🇸Cary, North Carolina, United States
Holston Valley Medical
🇺🇸Kingsport, Tennessee, United States
Danbury Hospital
🇺🇸Danbury, Connecticut, United States
Klinikum rechts der Isar
🇩🇪Muenchen, Germany
Baptist Hospital of Miami
🇺🇸Miami, Florida, United States
Sentara Vascular Specialists
🇺🇸Norfolk, Virginia, United States
Tisch Hospital NYU Langone Health
🇺🇸New York, New York, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
Sanger Heart & Vascular Institute
🇺🇸Charlotte, North Carolina, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Good Samaritan Hospital of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Baylor College of Medicine (St. Luke's Medical Center)
🇺🇸Houston, Texas, United States
St. Franziskus-Hospital - Münster
🇩🇪Münster, Germany
Hospital Clínico Universitario de Santiago
🇪🇸Santiago De Compostela, Spain