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Trial record 1 of 1 for:    A Study of Patients with Lower Extremity Acute Limb Ischemia to Remove Thrombus with the Indigo® Aspiration System
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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04144959
Recruitment Status : Recruiting
First Posted : October 30, 2019
Last Update Posted : March 9, 2021
Sponsor:
Information provided by (Responsible Party):
Penumbra Inc.

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

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Study Type : Observational
Estimated Enrollment : 130 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 2022
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


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




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 ]


Information from the National Library of Medicine

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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.

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


Contacts
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Contact: Ella Reyes +1 510 995 2343 ereyes@penumbrainc.com
Contact: Michaella Corso +1 510 995 2079 mcorso@penumbrainc.com

Locations
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United States, California
Stanford University Medical Center Recruiting
Stanford, California, United States, 94305
Contact: Jordan Stern, MD         
United States, Connecticut
Danbury Hospital Recruiting
Danbury, Connecticut, United States, 06810
Contact: Alan Dietzek, MD         
United States, Florida
Baptist Hospital of Miami Recruiting
Miami, Florida, United States, 33176
Contact: Alex Powell, MD         
United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 20742
Contact: Khanjan Nagarsheth, MD         
United States, New York
Albany Medical Center Recruiting
Albany, New York, United States, 12208
Contact: Paul Kreienberg, MD         
Tisch Hospital NYU Langone Health Recruiting
New York, New York, United States, 10016
Contact: Thomas Maldonado, MD         
United States, North Carolina
NC Heart and Vascular Research Recruiting
Cary, North Carolina, United States, 27607
Contact: Robert Mendes, MD         
Sanger Heart & Vascular Institute Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Frank Arko, MD         
United States, Ohio
Good Samaritan Hospital of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45220
Contact: Patrick Muck, MD         
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Jarrad Rowse, MD         
United States, Texas
Baylor College of Medicine (St. Luke's Medical Center) Recruiting
Houston, Texas, United States, 77030
Contact: Jayer Chung, MD         
United States, Virginia
Sentara Vascular Specialists Recruiting
Norfolk, Virginia, United States, 23507
Contact: David Dexter, MD         
Sponsors and Collaborators
Penumbra Inc.
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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: March 9, 2021
Last Verified: March 2021
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