Lower Extremity Acute Limb IschemiaSTRIDENCT04144959
A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo Aspiration System
An observational study of Lower Extremity Acute Limb Ischemia and LE ALI, run by Penumbra Inc. at 17 sites in 3 countries.
Trial 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). 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
- 119 participants
- Where
- 17 sitesin 3 countries
- Study dates
- 17 Dec 2019to 20 Oct 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Indigao Aspiration System
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
17 sites in 3 countries.
17 sites in 3 countries
United States14 sites
Albany Medical Center
Albany, New York, 12208
University of Maryland
Baltimore, Maryland, 20742
Manatee Memorial Hospital
Bradenton, Florida, 34208
NC Heart and Vascular Research
Cary, North Carolina, 27607
Sanger Heart & Vascular Institute
Charlotte, North Carolina, 28203
Trihealth Good Samaritan Hospital of Cincinnati
Cincinnati, Ohio, 45220
Cleveland Clinic
Cleveland, Ohio, 44195
Danbury Hospital
Danbury, Connecticut, 06810
Baylor College of Medicine (St. Luke's Medical Center)
Houston, Texas, 77030
Holston Valley Medical
Kingsport, Tennessee, 37660
Baptist Hospital of Miami
Miami, Florida, 33176
Tisch Hospital NYU Langone Health
New York, New York, 10016
Sentara Vascular Specialists
Norfolk, Virginia, 23507
Stanford University Medical Center
Stanford, California, 94305
Germany2 sites
Klinikum rechts der Isar
München
St. Franziskus-Hospital - Münster
Münster
About this study
Official title: STRIDE: 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).
- 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
Indigo Aspiration System
| Study group | Role | What they receive |
|---|---|---|
| Patients with lower extremity acute limb ischemia | Not described 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
Proportion of participants who did not have a major amputation (above the level of the tarsometatarsal joint)
Measured: 1-Month Post Procedure
Secondary outcomes (8)
Technical Success
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.
Measured: Immediate Post Procedure
Modified Society for Vascular Surgery Runoff Score
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
Measured: Pre Procedure and immediately Post Procedure
Improvement of Rutherford Classification
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
Measured: Up to discharge or 7 days, whichever occurred first
Vessel Patency
Patency is defined as a target lesion without a hemodynamically significant stenosis /reocclusion on duplex ultrasound (>50 %, ) and without target lesion reintervention (TLR ).
Measured: 1-Month Post-Procedure
Target Limb Salvage Rate
Proportion of participants who did not have a major amputation (above the level of the tarsometatarsal joint)
Measured: 12-Months Post Procedure
Rates of Device Related Serious Adverse Events (SAEs)
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
Measured: Up until study completion, at approximately 12-Months
Major Bleeding Peri-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
Measured: within 2 days of procedure
Mortality
Death due to any cause
Measured: 12-Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start17 Dec 2019
- Primary completion2 Jan 2023
- Study completion20 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penumbra Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Maldonado, MD, Principal investigator, NYU Langone Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04144959
- Sponsor's protocol ID
- CLP 15549
- Acronym
- STRIDE
- Status last verified
- Jun 2025
- First submitted
- 14 Oct 2019
- Last updated
- 27 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Maldonado TS, Powell A, Wendorff H, Rowse J, Nagarsheth KH, Dexter DJ, Dietzek AM, Muck PE, Arko FR, Chung J; STRIDE study group. STRIDE study post hoc analysis shows first-line mechanical aspiration thrombectomy for either in-stent or in-graft versus native vessel thrombosis in lower extremity acute limb ischemia yields similar outcomes. J Vasc Surg. 2026 Mar;83(3):839-847.e1. doi: 10.1016/j.jvs.2025.10.038. Epub 2025 Oct 31.
PubMed 41177276Maldonado TS, Powell A, Wendorff H, Rowse J, Nagarsheth KH, Dexter DJ, Dietzek AM, Muck PE, Arko FR, Chung J; STRIDE study group. One-year limb salvage and quality of life following mechanical aspiration thrombectomy in patients with acute lower extremity ischemia. J Vasc Surg. 2024 Oct;80(4):1159-1168.e5. doi: 10.1016/j.jvs.2024.05.043. Epub 2024 Jun 22.
PubMed 38914349Maldonado TS, Powell A, Wendorff H, Rowse J, Nagarsheth KH, Dexter DJ, Dietzek AM, Muck PE, Arko FR, Chung J; STRIDE study group. Safety and efficacy of mechanical aspiration thrombectomy for patients with acute lower extremity ischemia. J Vasc Surg. 2024 Mar;79(3):584-592.e5. doi: 10.1016/j.jvs.2023.10.062. Epub 2023 Nov 4.
PubMed 37931885
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STRIDE: A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo Aspiration System
- ClinicalTrials.gov ID
- NCT04144959
- Acronym / sponsor ID
- STRIDE / CLP 15549
- Conditions
- Lower Extremity Acute Limb Ischemia, LE ALI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Penumbra Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Dec 2019 (actual)
- Primary completion
- 2 Jan 2023 (actual)
- Study completion
- 20 Oct 2023 (actual)
- First posted
- 30 Oct 2019 (actual)
- Results
- Posted 27 Jun 2025
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 safety and performance data on 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 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 Indigao Aspiration System
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (8 listed)
- 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)
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 SystemIndigo Aspiration System | Device | Patients with lower extremity acute limb ischemia |
Primary outcome
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)
8 secondary outcomes
Technical Success
Time frame: Immediate Post Procedure
Modified Society for Vascular Surgery Runoff Score
Time frame: Pre Procedure and immediately Post Procedure
Improvement of Rutherford Classification
Time frame: Up to discharge or 7 days, whichever occurred first
Vessel Patency
Time frame: 1-Month Post-Procedure
Target Limb Salvage Rate
Time frame: 12-Months Post Procedure
Rates of Device Related Serious Adverse Events (SAEs)
Time frame: Up until study completion, at approximately 12-Months
Major Bleeding Peri-procedure
Time frame: within 2 days of procedure
Mortality
Time frame: 12-Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41177276Maldonado TS, Powell A, Wendorff H, Rowse J, Nagarsheth KH, Dexter DJ, Dietzek AM, Muck PE, Arko FR, Chung J; STRIDE study group. STRIDE study post hoc analysis shows first-line mechanical aspiration thrombectomy for either in-stent or in-graft versus native vessel thrombosis in lower extremity acute limb ischemia yields similar outcomes. J Vasc Surg. 2026 Mar;83(3):839-847.e1. doi: 10.1016/j.jvs.2025.10.038. Epub 2025 Oct 31.
- Derived from this study: PubMed 38914349Maldonado TS, Powell A, Wendorff H, Rowse J, Nagarsheth KH, Dexter DJ, Dietzek AM, Muck PE, Arko FR, Chung J; STRIDE study group. One-year limb salvage and quality of life following mechanical aspiration thrombectomy in patients with acute lower extremity ischemia. J Vasc Surg. 2024 Oct;80(4):1159-1168.e5. doi: 10.1016/j.jvs.2024.05.043. Epub 2024 Jun 22.
- Derived from this study: PubMed 37931885Maldonado TS, Powell A, Wendorff H, Rowse J, Nagarsheth KH, Dexter DJ, Dietzek AM, Muck PE, Arko FR, Chung J; STRIDE study group. Safety and efficacy of mechanical aspiration thrombectomy for patients with acute lower extremity ischemia. J Vasc Surg. 2024 Mar;79(3):584-592.e5. doi: 10.1016/j.jvs.2023.10.062. Epub 2023 Nov 4.
- 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. This study is not recruiting at the moment.
Thomas Maldonado, MD principal investigator
NYU Langone Medical Center
17 sites in 3 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 17 sites in 3 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 5 inclusion and 8 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: finished, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Germany, Spain. 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?
Yes. Results are posted in the registry (first posted 27 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target Limb Salvage Rate (time frame: 1-Month 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 NCT04144959, which also lists 3 linked publications.
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 27 Jun 2025.