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Lower Extremity Acute Limb IschemiaSTRIDE IINCT06747117

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

An observational study of Lower Extremity Acute Limb Ischemia and LE ALI, run by Penumbra Inc. at 45 sites in 7 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lower Extremity Acute Limb Ischemia, LE ALI
What is being tested?
Indigo Aspiration System
Type of treatment
Medical device
How many people
300 participants
Where
45 sitesin 7 countries
Study dates
18 May 2025to Jan 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients that present with LE ALI who are eligible for mechanical thrombectomy using the Indigo Aspiration System

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

45 sites in 7 countries. Contact the study team or a site near you to ask about taking part.

Marina Mello contact

+14078108634

mmello@penumbrainc.com

Jemymah Allen contact

+13109485738

jallen@penumbrainc.com

45 sites in 7 countries

United States35 sites, 34 recruiting

  • Emory University Hospital

    Atlanta, Georgia, 30322

    Recruiting

  • University of Colorado Hospital

    Aurora, Colorado, 80045

    Recruiting

  • University of Maryland

    Baltimore, Maryland, 21201

    Recruiting

  • Manatee Memorial Hospital

    Bradenton, Florida, 34208

    Recruiting

  • UNC Medical Center Hospital

    Chapel Hill, North Carolina, 27514

    Recruiting

  • TriHealth Good Samaritan Hospital

    Cincinnati, Ohio, 45220

    Recruiting

  • Cleveland Clinic

    Cleveland, Ohio, 44195

    Recruiting

  • Sanger Heart & Vascular Institute

    Concord, North Carolina, 28204

    Recruiting

  • William P. Clements Jr. University Hospital

    Dallas, Texas, 75235

    Recruiting

  • University of Florida Shands Hospital

    Gainesville, Florida, 32608

    Recruiting

  • Prisma Health Greenville Memorial Hospital

    Greenville, South Carolina, 29605

    Recruiting

  • Baylor St. Luke's Medical Center

    Houston, Texas, 77030

    Recruiting

  • Indiana University Health Methodist Hospital

    Indianapolis, Indiana, 46202

    Recruiting

  • Jackson-Madison County General Hospital

    Jackson, Tennessee, 38301

    Recruiting

  • Radiology and Imaging Specialists

    Lakeland, Florida, 33805

    Recruiting

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03766

    Recruiting

  • University of Kentucky

    Lexington, Kentucky, 40536

    Recruiting

  • Baptist Hospital of Miami, Miami Cardiac and Vascular Institute

    Miami, Florida, 33176

    Recruiting

  • The Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Recruiting

  • Community Hospital

    Munster, Indiana, 46321

    Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

    Recruiting

  • Yale New Haven Hospital

    New Haven, Connecticut, 06520

    Recruiting

  • NYU Langone Health

    New York, New York, 10016

    Recruiting

  • Mount Sinai Hospital

    New York, New York, 10029

    Recruiting

  • Christiana Care Health Services, Inc.

    Newark, Delaware, 19713

    Recruiting

  • OSF Saint Francis Medical Center

    Peoria, Illinois, 61637

    Withdrawn

  • Baylor Scott & White The Heart Hospital - Plano

    Plano, Texas, 75093

    Recruiting

  • NC Heart and Vascular Research, LLC

    Raleigh, North Carolina, 27607

    Recruiting

  • Sharp Memorial Hospital

    San Diego, California, 92123

    Recruiting

  • HonorHealth Scottsdale Osborn Medical Center

    Scottsdale, Arizona, 85251

    Recruiting

  • Saint Louis University Hospital

    St Louis, Missouri, 63104

    Recruiting

  • Tampa General Hospital

    Tampa, Florida, 33606

    Recruiting

  • Community Memorial Hospital

    Ventura, California, 93003

    Recruiting

  • Lexington Medical Center

    West Columbia, South Carolina, 29169

    Recruiting

  • UMass Memorial Medical Center

    Worcester, Massachusetts, 01655

    Recruiting

Other trials in United States

Germany3 sites, 3 recruiting

  • Universitätsklinikum Köln

    Cologne

    Recruiting

  • Universitätsklinik Leipzig

    Leipzig, 04103

    Recruiting

  • Klinikum Stuttgart - Katharinenhospital

    Stuttgart, 70174

    Recruiting

Other trials in Germany

Australia2 sites, 2 recruiting

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042

    Recruiting

  • Royal North Shore Hospital

    Sydney, NSW 2065

    Recruiting

Other trials in Australia

Italy2 sites, 2 recruiting

  • ASST Degli Spedali Civili di Brescia

    Brescia, 25123

    Recruiting

  • Ospedale Policlinico San Martino, Genova

    Genoa

    Recruiting

Other trials in Italy

Brazil1 site, 1 recruiting

  • UFMG Hospital Risoleta Tolentino Neves

    Belo Horizonte, 31744-012

    Recruiting

Other trials in Brazil

Malaysia1 site, 1 recruiting

  • Institut Jantung Negara Sdn Bhd

    Kuala Lumpur

    Recruiting

Other trials in Malaysia

Switzerland1 site, 1 recruiting

  • Lausanne University Hospital

    Lausanne, 1005

    Recruiting

Other trials in Switzerland

About this study

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

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).

Being tested
Indigo Aspiration System

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Indigo Aspiration SystemDevice

    Mechanical aspiration thrombectomy with the Indigo Aspiration System.

Study groups in NCT06747117
Study groupRoleWhat they receive
Patients with lower extremity acute limb ischemiaDevice: Indigo Aspiration System
Receives: Device: Indigo Aspiration System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Target Limb Salvage Rate

    Measured: 30 Days Post-Procedure

Secondary outcomes (6)

  1. Technical Success

    Technical success by treated segment defined as Thromboaspiration in Peripheral Ischemia (TIPI) 2/3 flow immediately post procedure by physician visual assessment of intraprocedural angiography

    Measured: Immediate Post Procedure

  2. Primary Patency at 30 Days

    Measured: 30 Days Post-Procedure

  3. Rates of Device-related Major Bleeding

    Measured: Procedure, 30 Days, and 180 Days Post-Procedure

  4. Rates of Device-related Distal Embolization

    Measured: During Procedure

  5. Rates of Device-related Serious Adverse Events (SAE)

    Measured: Procedure, 30 Days, and 180 Days Post-Procedure

  6. Mortality

    All cause mortality at 30 and 180 days

    Measured: 30 Days and 180 Days Post-Procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2024
  2. Study start18 May 2025
  3. Primary completionJun 2028 (estimated)
  4. Study completionJan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06747117
Sponsor's protocol ID
CLP 30000
Acronym
STRIDE II
Status last verified
Aug 2026
First submitted
18 Dec 2024
Last updated
31 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Lower Extremity Acute Limb Ischemia and LE ALI, run by Penumbra Inc. at 45 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in United States, Germany, Australia, Italy, Brazil and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Marina Mello (+14078108634, mmello@penumbrainc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Target Limb Salvage Rate (time frame: 30 Days Post-Procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06747117.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.

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