RECRUITING

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

Talk to us

Conditions

Lower Extremity Acute Limb IschemiaLE ALI

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2025-05-18
Study Completion:2029-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06747117

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥18 years
  2. * 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
  3. * Acute occlusion with symptom duration of 14 days or less at presentation
  4. * ALI Rutherford Category I, IIa or IIb
  5. * First-line treatment with the Indigo Aspiration System using Computer Assisted Vacuum Thrombectomy (CAVT) aspiration tubing
  6. * Informed consent is obtained from either patient or legally authorized representative (LAR) per Institutional Review Board/Ethics Committee requirements
  7. * 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
  1. * Life expectancy \<1 year
  2. * Target vessel size \<2 mm
  3. * Target thrombus is in the aorta or isolated profunda artery
  4. * Prior major amputation (proximal to the tarsometatarsal joint) in the target limb
  5. * Prior minor amputation in the target limb within the past 6 months that is not completely healed or cannot bear weight
  6. * LE ALI secondary to dissection, vasculitis, or target vessel trauma, including iatrogenic etiology from treatment of a proximal location in the target limb
  7. * Target thrombus in a saphenous vein bypass graft
  8. * Treatment of the index event with thrombolytics or any other endovascular or open surgical method prior to enrollment
  9. * Pregnancy
  10. * Contraindication or sensitivity to iodinated intravascular contrast that cannot be adequately premedicated
  11. * 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
  12. * 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

Contacts and Locations

Study Contact

Marina Mello
CONTACT
+14078108634
mmello@penumbrainc.com
Jemymah Allen
CONTACT
+13109485738
jallen@penumbrainc.com

Principal Investigator

Daniel Clair, MD
PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center
Dierk Scheinert, MD
PRINCIPAL_INVESTIGATOR
Universitätsklinikum Leipzig

Study Locations (Sites)

University of Maryland
Baltimore, Maryland, 21201
United States

Collaborators and Investigators

Sponsor: Penumbra Inc.

  • Daniel Clair, MD, PRINCIPAL_INVESTIGATOR, Vanderbilt University Medical Center
  • Dierk Scheinert, MD, PRINCIPAL_INVESTIGATOR, Universitätsklinikum Leipzig

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-18
Study Completion Date2029-01

Study Record Updates

Study Start Date2025-05-18
Study Completion Date2029-01

Terms related to this study

Additional Relevant MeSH Terms

  • Lower Extremity Acute Limb Ischemia
  • LE ALI