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

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

The primary objective of this study is to collect and evaluate clinical evidence supporting the safety and performance of the Indigo™ Aspiration System in a patient population with lower extremity acute limb ischemia (LE ALI).

Study Overview

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

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Marina Mello; Phone Number: +14078108634; Email: mmello@penumbrainc.com
• Study Contact Backup: Name: Jemymah Allen; Phone Number: +13109485738; Email: jallen@penumbrainc.com

Study Locations

• Australia
  • South Australia
    • Bedford Park, South Australia, Australia, 5042
      • Recruiting
      • Flinders Medical Centre
• Germany
  • Leipzig, Germany, 04103
    • Recruiting
    • Universitätsklinik Leipzig
  • Stuttgart, Germany, 70174
    • Recruiting
    • Klinikum Stuttgart - Katharinenhospital
• Italy
  • Brescia, Italy, 25123
    • Recruiting
    • Asst Degli Spedali Civili Di Brescia
  • Genoa, Italy
    • Recruiting
    • Ospedale Policlinico San Martino, Genova
• Switzerland
  • Lausanne, Switzerland, 1005
    • Recruiting
    • Lausanne University Hospital
• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85251
      • Recruiting
      • HonorHealth Scottsdale Osborn Medical Center
  • California
    • San Diego, California, United States, 92123
      • Recruiting
      • Sharp Memorial Hospital
    • Ventura, California, United States, 93003
      • Recruiting
      • Community Memorial Hospital
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado Hospital
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Recruiting
      • Yale New Haven Hospital
  • Delaware
    • Newark, Delaware, United States, 19713
      • Recruiting
      • Christiana Care Health Services, Inc.
  • Florida
    • Bradenton, Florida, United States, 34208
      • Recruiting
      • Manatee Memorial Hospital
    • Gainesville, Florida, United States, 32608
      • Recruiting
      • University of Florida Shands Hospital
    • Lakeland, Florida, United States, 33805
      • Recruiting
      • Radiology and Imaging Specialists
    • Miami, Florida, United States, 33176
      • Recruiting
      • Baptist Hospital of Miami, Miami Cardiac and Vascular Institute
    • Tampa, Florida, United States, 33606
      • Recruiting
      • Tampa General Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Emory University Hospital
  • Illinois
    • Peoria, Illinois, United States, 61637
      • Recruiting
      • OSF Saint Francis Medical Center
  • Indiana
    • Munster, Indiana, United States, 46321
      • Recruiting
      • Community Hospital
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • Recruiting
      • University Of Kentucky
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Recruiting
      • University of Maryland
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • Recruiting
      • UMass Memorial Medical Center
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03766
      • Recruiting
      • Dartmouth Hitchcock Medical Center
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone Health
    • New York, New York, United States, 10029
      • Recruiting
      • Mount Sinai Hospital
  • North Carolina
    • Concord, North Carolina, United States, 28204
      • Recruiting
      • Sanger Heart & Vascular Institute
    • Raleigh, North Carolina, United States, 27607
      • Recruiting
      • NC Heart and Vascular Research, LLC
  • Ohio
    • Cincinnati, Ohio, United States, 45220
      • Recruiting
      • TriHealth Good Samaritan Hospital
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Recruiting
      • Prisma Health Greenville Memorial Hospital
    • West Columbia, South Carolina, United States, 29169
      • Recruiting
      • Lexington Medical Center
  • Tennessee
    • Jackson, Tennessee, United States, 38301
      • Recruiting
      • Jackson-Madison County General Hospital
  • Texas
    • Dallas, Texas, United States, 75235
      • Recruiting
      • William P. Clements Jr. University Hospital
    • Houston, Texas, United States, 77030
      • Recruiting
      • Baylor St. Luke's Medical Center
    • Plano, Texas, United States, 75093
      • Recruiting
      • Baylor Scott & White The Heart Hospital - Plano
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Recruiting
      • The Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 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 Indigo Aspiration System

Description

Inclusion Criteria:

• Age ≥18 years
• Patients with a confirmed diagnosis of lower limb arterial occlusion located in the common iliac or below, with a minimum of 2 cm of proximal patency in the common iliac
• Acute occlusion with symptom duration of 14 days or less at presentation
• ALI Rutherford Category I, IIa or IIb
• First-line treatment with the Indigo Aspiration System using Computer Assisted Vacuum Thrombectomy (CAVT) aspiration tubing
• Informed consent is obtained from either patient or legally authorized representative (LAR) per Institutional Review Board/Ethics Committee requirements
• Previously enrolled patients presenting with a new acute occlusion in the contralateral limb meeting all eligibility criteria may be re-enrolled if the new acute occlusion is greater than 30 days from the initial index procedure

Exclusion Criteria:

• Life expectancy <1 year
• Target vessel size <2 mm
• Target thrombus is in the aorta or isolated profunda artery
• Prior major amputation (proximal to the tarsometatarsal joint) in the target limb
• Prior minor amputation in the target limb within the past 6 months that is not completely healed or cannot bear weight
• LE ALI secondary to dissection, vasculitis, or target vessel trauma, including iatrogenic etiology from treatment of a proximal location in the target limb, and non-thrombotic material such as tumor fragments, fat emboli, septic emboli, and foreign bodies
• Target thrombus in a vein bypass graft, previously revised bypass grafts, bypass grafts placed < 3 months prior to index ALI symptom onset, or bypass grafts with a distal anastomosis below the popliteal artery
• Treatment of the index event with thrombolytics or any other endovascular or open surgical method prior to enrollment
• Pregnancy
• Contraindication or sensitivity to iodinated intravascular contrast that cannot be adequately premedicated
• Other medical, behavioral, or psychological conditions that, in the opinion of the Investigator, precludes the patient from appropriate consent, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study
• Current participation in another investigational drug or device study that may confound the results of this study. Studies requiring extended follow-up for products that were investigational but have since become

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with lower extremity acute limb ischemia; Device: Indigo Aspiration System	Device: Indigo Aspiration System; Mechanical aspiration thrombectomy with the Indigo Aspiration System.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Target Limb Salvage Rate	30 Days Post-Procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Patency at 30 Days		30 Days Post-Procedure
Rates of Device-related Major Bleeding		Procedure, 30 Days, and 180 Days Post-Procedure
Rates of Device-related Distal Embolization		During Procedure
Rates of Device-related Serious Adverse Events (SAE)		Procedure, 30 Days, and 180 Days Post-Procedure
Mortality	All cause mortality at 30 and 180 days	30 Days and 180 Days Post-Procedure
Technical Success	Technical success by treated segment defined as Thromboaspiration in Peripheral Ischemia (TIPI) 2/3 flow immediately post procedure by physician visual assessment of intraprocedural angiography	Immediate Post Procedure

Collaborators and Investigators

• Sponsor: Penumbra Inc.
• Investigators: Principal Investigator: Daniel Clair, MD, Vanderbilt University Medical Center; Principal Investigator: Dierk Scheinert, MD, Universitätsklinik Leipzig

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: December 18, 2024
• First Submitted That Met QC Criteria: December 18, 2024
• First Posted (Actual): December 24, 2024

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Ischemia
• Other Study ID Numbers: CLP 30000

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