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Recruiting NCT06747117

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

— Observational Lower Extremity Acute Limb Ischemia LE ALI

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Indigo Aspiration System.
Who it may be relevant to
Registry conditions: Lower Extremity Acute Limb Ischemia, LE ALI. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, Brazil, Germany, Italy +1
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

  • Device Indigo Aspiration System
    Mechanical aspiration thrombectomy with the Indigo Aspiration System.

Primary outcome measures

  • Target Limb Salvage Rate [Time frame: 30 Days Post-Procedure]
Secondary outcome measures (6)
  • Technical Success [Time frame: Immediate Post Procedure]
  • Primary Patency at 30 Days [Time frame: 30 Days Post-Procedure]
  • Rates of Device-related Major Bleeding [Time frame: Procedure, 30 Days, and 180 Days Post-Procedure]
  • Rates of Device-related Distal Embolization [Time frame: During Procedure]
  • Rates of Device-related Serious Adverse Events (SAE) [Time frame: Procedure, 30 Days, and 180 Days Post-Procedure]
  • Mortality [Time frame: 30 Days and 180 Days Post-Procedure]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 34 centers
  • HonorHealth Scottsdale Osborn Medical Center — Scottsdale
  • Sharp Memorial Hospital — San Diego
  • Community Memorial Hospital — Ventura
  • University of Colorado Hospital — Aurora
  • Yale New Haven Hospital — New Haven
  • Christiana Care Health Services, Inc. — Newark
  • Manatee Memorial Hospital — Bradenton
  • University of Florida Shands Hospital — Gainesville
  • … and 26 more centers
Australia · 2 centers
  • Flinders Medical Centre — Bedford Park
  • Royal North Shore Hospital — Sydney
Germany · 2 centers
  • Universitätsklinik Leipzig — Leipzig
  • Klinikum Stuttgart - Katharinenhospital — Stuttgart
Italy · 2 centers
  • ASST Degli Spedali Civili di Brescia — Brescia
  • Ospedale Policlinico San Martino, Genova — Genoa
Brazil · 1 center
  • UFMG Hospital Risoleta Tolentino Neves — Belo Horizonte
Switzerland · 1 center
  • Lausanne University Hospital — Lausanne

Identifiers

NCT: NCT06747117 · CLP 30000

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗