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

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

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 Overview

• Status: Completed
• Conditions: Lower Extremity Acute Limb Ischemia; LE ALI
• Intervention / Treatment: Device: Indigo Aspiration System

• Study Type: Observational
• Enrollment (Actual): 119

Contacts and Locations

Study Locations

• Germany
  • Muenchen, Germany
    • Klinikum Rechts der Isar
  • Münster, Germany
    • St. Franziskus-Hospital - Münster
• Spain
  • Santiago De Compostela, Spain
    • Hospital Clínico Universitario de Santiago
• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University Medical Center
  • Connecticut
    • Danbury, Connecticut, United States, 06810
      • Danbury Hospital
  • Florida
    • Bradenton, Florida, United States, 34208
      • Manatee Memorial Hospital
    • Miami, Florida, United States, 33176
      • Baptist Hospital of Miami
  • Maryland
    • Baltimore, Maryland, United States, 20742
      • University of Maryland
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical Center
    • New York, New York, United States, 10016
      • Tisch Hospital NYU Langone Health
  • North Carolina
    • Cary, North Carolina, United States, 27607
      • NC Heart and Vascular Research
    • Charlotte, North Carolina, United States, 28203
      • Sanger Heart & Vascular Institute
  • Ohio
    • Cincinnati, Ohio, United States, 45220
      • Trihealth Good Samaritan Hospital of Cincinnati
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Holston Valley Medical
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine (St. Luke's Medical Center)
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Vascular Specialists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients that present with LE ALI who are eligible for mechanical thrombectomy using the Indigao Aspiration System

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with lower extremity acute limb ischemia	Device: Indigo Aspiration System; Indigo Aspiration System

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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	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 ).	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)	12-Months Post Procedure
Rates of Device Related Serious Adverse Events (SAEs)	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	Up until study completion, at approximately 12-Months
Major Bleeding Peri-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	within 2 days of procedure
Mortality	Death due to any cause	12-Months

Collaborators and Investigators

• Sponsor: Penumbra Inc.
• Investigators: Principal Investigator: Thomas Maldonado, MD, NYU Langone Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2019
• Primary Completion (Actual): January 2, 2023
• Study Completion (Actual): October 20, 2023

Study Registration Dates

• First Submitted: October 14, 2019
• First Submitted That Met QC Criteria: October 28, 2019
• First Posted (Actual): October 30, 2019

Study Record Updates

• Last Update Posted (Actual): June 27, 2025
• Last Update Submitted That Met QC Criteria: June 18, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Ischemia
• Other Study ID Numbers: CLP 15549

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No