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Trial record 1 of 1 for:    NCT04144959
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A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo Aspiration System (STRIDE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04144959
Recruitment Status : Active, not recruiting
First Posted : October 30, 2019
Last Update Posted : December 21, 2022
Sponsor:
Information provided by (Responsible Party):
Penumbra Inc.

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment
Lower Extremity Acute Limb Ischemia LE ALI Device: Indigo Aspiration System

Study Design
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Study Type : Observational
Actual Enrollment : 118 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: STRIDE: A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo Aspiration System
Actual Study Start Date : December 17, 2019
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Patients with lower extremity acute limb ischemia Device: Indigo Aspiration System
Indigo Aspiration System


Outcome Measures
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Primary Outcome Measures :
  1. Target limb salvage rate [ Time Frame: 1-Month Post Procedure ]

Secondary Outcome Measures :
  1. Technical Success [ Time Frame: Immediate Post Procedure ]

    Defined as TIMI 2/3 flow rate

    TIMI flow grading range 1-3, with higher grading representing better outcome


  2. Modified SVS runoff score [ Time Frame: Immediate Post Procedure ]

    Immediate Post Procedure as compared to Baseline

    Modified SVS runoff score ranges from 0-19, with a higher score indicating more severe disease


  3. Improvement of Rutherford classification [ Time Frame: Up until study completion, at approximately 12-Months ]

    Improvement of one or more as compared to pre-procedure

    Rutherford classification ranges from I-III, with a higher score representing worse outcomes


  4. Vessel Patency [ Time Frame: 1-Month Post-Procedure ]
  5. Target limb salvage rate [ Time Frame: 12-Months Post Procedure ]
  6. Rates of device related serious adverse events (SAEs) [ Time Frame: Up until study completion, at approximately 12-Months ]
  7. Major bleeding peri-procedure [ Time Frame: During procedure ]
  8. Mortality [ Time Frame: 12-Months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 Indigao Aspiration System
Criteria

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 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04144959


Locations
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Sponsors and Collaborators
Penumbra Inc.
Investigators
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Principal Investigator: Thomas Maldonado, MD NYU Langone Medical Center
More Information
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Responsible Party: Penumbra Inc.
ClinicalTrials.gov Identifier: NCT04144959    
Other Study ID Numbers: CLP 15549
First Posted: October 30, 2019    Key Record Dates
Last Update Posted: December 21, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Ischemia
Pathologic Processes