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Clinical Trials in the USA / NCT06747117
Recruiting Observational

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

NCT06747117 · tracked via the Priya Life Science USA tracker
Sponsor
Penumbra Inc.
Phase
Observational
Started
2025-05-18
Last updated
2026-08-31

Condition(s) studied

Lower Extremity Acute Limb IschemiaLE ALI

Investigational drug(s) / intervention(s)

Indigo Aspiration System

Indigo Aspiration System: Mechanical aspiration thrombectomy with the Indigo Aspiration System.

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (45)

FacilityCityRegionStatus
HonorHealth Scottsdale Osborn Medical Center Scottsdale Arizona Recruiting
Sharp Memorial Hospital San Diego California Recruiting
Community Memorial Hospital Ventura California Recruiting
University of Colorado Hospital Aurora Colorado Recruiting
Yale New Haven Hospital New Haven Connecticut Recruiting
Christiana Care Health Services, Inc. Newark Delaware Recruiting
Manatee Memorial Hospital Bradenton Florida Recruiting
University of Florida Shands Hospital Gainesville Florida Recruiting
Radiology and Imaging Specialists Lakeland Florida Recruiting
Baptist Hospital of Miami, Miami Cardiac and Vascular Institute Miami Florida Recruiting
Tampa General Hospital Tampa Florida Recruiting
Emory University Hospital Atlanta Georgia Recruiting
OSF Saint Francis Medical Center Peoria Illinois Withdrawn
Indiana University Health Methodist Hospital Indianapolis Indiana Recruiting
Community Hospital Munster Indiana Recruiting
University of Kentucky Lexington Kentucky Recruiting
University of Maryland Baltimore Maryland Recruiting
UMass Memorial Medical Center Worcester Massachusetts Recruiting
Saint Louis University Hospital St Louis Missouri Recruiting
Dartmouth Hitchcock Medical Center Lebanon New Hampshire Recruiting
NYU Langone Health New York New York Recruiting
Mount Sinai Hospital New York New York Recruiting
UNC Medical Center Hospital Chapel Hill North Carolina Recruiting
Sanger Heart & Vascular Institute Concord North Carolina Recruiting
NC Heart and Vascular Research, LLC Raleigh North Carolina Recruiting
TriHealth Good Samaritan Hospital Cincinnati Ohio Recruiting
Cleveland Clinic Cleveland Ohio Recruiting
Prisma Health Greenville Memorial Hospital Greenville South Carolina Recruiting
Lexington Medical Center West Columbia South Carolina Recruiting
Jackson-Madison County General Hospital Jackson Tennessee Recruiting
Vanderbilt University Medical Center Nashville Tennessee Recruiting
William P. Clements Jr. University Hospital Dallas Texas Recruiting
Baylor St. Luke's Medical Center Houston Texas Recruiting
Baylor Scott & White The Heart Hospital - Plano Plano Texas Recruiting
The Medical College of Wisconsin Milwaukee Wisconsin Recruiting
Flinders Medical Centre Bedford Park South Australia Recruiting
Royal North Shore Hospital Sydney Australia Recruiting
UFMG Hospital Risoleta Tolentino Neves Belo Horizonte Brazil Recruiting
Universitätsklinikum Köln Cologne Germany Recruiting
Universitätsklinik Leipzig Leipzig Germany Recruiting

+ 5 more sites — see the full list on the official registry below.

More Penumbra Inc. trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06747117 on ClinicalTrials.gov ↗ ← All trials in the USA