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.
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.
45 sites in 7 countries
United States35 sites, 34 recruiting
- 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
- Withdrawn
OSF Saint Francis Medical Center
Peoria, Illinois, 61637
- Recruiting
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
Germany3 sites, 3 recruiting
- Recruiting
Universitätsklinikum Köln
Cologne
- Recruiting
Universitätsklinik Leipzig
Leipzig, 04103
- Recruiting
Klinikum Stuttgart - Katharinenhospital
Stuttgart, 70174
Australia2 sites, 2 recruiting
- Recruiting
Flinders Medical Centre
Bedford Park, South Australia, 5042
- Recruiting
Royal North Shore Hospital
Sydney, NSW 2065
Italy2 sites, 2 recruiting
- Recruiting
ASST Degli Spedali Civili di Brescia
Brescia, 25123
- Recruiting
Ospedale Policlinico San Martino, Genova
Genoa
Brazil1 site, 1 recruiting
- Recruiting
UFMG Hospital Risoleta Tolentino Neves
Belo Horizonte, 31744-012
Malaysia1 site, 1 recruiting
- Recruiting
Institut Jantung Negara Sdn Bhd
Kuala Lumpur
Switzerland1 site, 1 recruiting
- Recruiting
Lausanne University Hospital
Lausanne, 1005
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).
- Conditions
- 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 group | Role | What they receive |
|---|---|---|
| Patients with lower extremity acute limb ischemia | Device: 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.
Target Limb Salvage Rate
Measured: 30 Days Post-Procedure
Secondary outcomes (6)
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
Primary Patency at 30 Days
Measured: 30 Days Post-Procedure
Rates of Device-related Major Bleeding
Measured: Procedure, 30 Days, and 180 Days Post-Procedure
Rates of Device-related Distal Embolization
Measured: During Procedure
Rates of Device-related Serious Adverse Events (SAE)
Measured: Procedure, 30 Days, and 180 Days Post-Procedure
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.
- First posted24 Dec 2024
- Study start18 May 2025
- Primary completionJun 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Extremity Acute Limb IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Penumbra Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Clair, MD, Principal investigator, Vanderbilt University Medical CenterDierk Scheinert, MD, Principal investigator, Universitätsklinik Leipzig
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
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STRIDE II: A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo™ Aspiration System II
- ClinicalTrials.gov ID
- NCT06747117
- Acronym / sponsor ID
- STRIDE II / CLP 30000
- Conditions
- Lower Extremity Acute Limb Ischemia, LE ALI
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Penumbra Inc.Industry (pharma, biotech, devices)
- Study start
- 18 May 2025 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 24 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with lower extremity acute limb ischemia | – | Device: Indigo Aspiration SystemDevice: Indigo Aspiration System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that present with LE ALI who are eligible for mechanical thrombectomy using the Indigo Aspiration System
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indigo Aspiration SystemMechanical aspiration thrombectomy with the Indigo Aspiration System. | Device | Patients with lower extremity acute limb ischemia |
Primary outcome
Target Limb Salvage Rate
Time frame: 30 Days Post-Procedure
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel Clair, MD principal investigator
Vanderbilt University Medical Center
Dierk Scheinert, MD principal investigator
Universitätsklinik Leipzig
45 sites in 7 countries: see every site and its status.
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?
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.