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Completed

NCT Number: NCT04144959

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).

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Key information

Conditions

Lower Extremity Acute Limb Ischemia LE ALI

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinikum rechts der Isar, München, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Indigo Aspiration System

Device

Indigo Aspiration System

Primary outcomes

  1. Target Limb Salvage Rate

    Time frame: 1-Month Post Procedure

    Proportion of participants who did not have a major amputation (above the level of the tarsometatarsal joint)

Secondary outcomes

  1. Technical Success

    Time frame: Immediate Post Procedure

    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.

  2. Modified Society for Vascular Surgery Runoff Score

    Time frame: Pre Procedure and immediately Post Procedure

    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

  3. Improvement of Rutherford Classification

    Time frame: Up to discharge or 7 days, whichever occurred first

    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

  4. Vessel Patency

    Time frame: 1-Month Post-Procedure

    Patency is defined as a target lesion without a hemodynamically significant stenosis /reocclusion on duplex ultrasound (>50 %, ) and without target lesion reintervention (TLR ).

  5. Target Limb Salvage Rate

    Time frame: 12-Months Post Procedure

    Proportion of participants who did not have a major amputation (above the level of the tarsometatarsal joint)

  6. Rates of Device Related Serious Adverse Events (SAEs)

    Time frame: Up until study completion, at approximately 12-Months

    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

  7. Major Bleeding Peri-procedure

    Time frame: within 2 days of 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

  8. Mortality

    Time frame: 12-Months

    Death due to any cause

Sponsors and collaborators

Lead sponsor

Penumbra Inc.

Industry

Registry information

Official study title

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

Acronym: STRIDE

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Oct 30, 2019
Registry last updated
Jun 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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