New stroke device aims to restore blood flow in distal brain clots

NCT ID NCT05152524

Disease control Sponsor: Rapid Medical Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Aug 13, 2026 · Updated 3 times

Summary

This trial tests a device called Tigertriever 13 to treat distal ischemic strokes, where a blood clot blocks a small artery deep in the brain. About 168 patients with disabling symptoms will receive either the device or standard medical care within 24 hours of stroke onset. The goal is to see if the device safely restores blood flow and improves outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Tigertriever 13 device
What this could lead to: If successful, this device could offer a new treatment option for distal ischemic strokes, potentially improving blood flow and reducing disability.
What could go wrong: This is an early-stage study with 168 participants, so results may not apply to everyone. There are risks of bleeding or other complications from the procedure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

149 people

The number who actually took part.

Started

Mar 2022

Finished

Mar 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age 18-85 years old. 2. Pre-stroke mRS ≤2. 3. Disabling presenting deficits that localize to the territory of the distal vessel occlusion. Disabling deficits are deficits that, if unchanged, would prevent the subject from performing basic activities of daily living (i.e., bathing, ambulating, toileting, hygiene, and eating) or returning to work. 4. NIHSS 4-24, or NIHSS 2-24 for patients with aphasia and/or hemianopia. 5. Perfusion lesion (Tmax \>4.0 seconds) volume ≥10 cc on CTP or MR PWI within the territory of the anterior cerebral artery (ACA) segments, a non-dominant or co-dominant M2 middle cerebral artery (MCA) segment, an M3 MCA, or the posterior cerebral artery (PCA) segments. 6. Occluded distal vessel diameter ≥1.5 mm as measured on CTA or MRA. 7. Ischemic core lesion (rCBF\<30% on CTP or ADC \<620 on MR DWI) in ≤50% of the perfusion lesion volume. 8. Study treatment can be initiated within 24 hours of last known well time (last known time without current stroke symptoms). 9. Signed informed consent by patient or legally authorized representative. 10. Subject is not eligible for intravenous thrombolysis within 3 hours from stroke onset per FDA label and American Heart Association/American Stroke Association national guidelines. (Note: administration of intravenous thrombolytics should not be avoided or delayed in order to achieve participation in this study.) Exclusion Criteria: 1. Evidence of acute brain hemorrhage on CT and/or MRI at admission. 2. Use of any other intra-arterial (IA) recanalization device prior to the Tigertriever 13 in the target vessel, including aspiration catheter. 3. The DVO is a secondary distal occlusion that occurred during a large vessel occlusion (LVO) thrombectomy procedure. 4. Excessive tortuosity or stenosis that is anticipated to prevent placement of the microcatheter in the target vessel. Tortuosity or stenosis will be determined on CTA or MRA prior to randomization. 5. Evidence of tandem occlusion in the cervical internal carotid artery (ICA), intracranial ICA, M1 MCA, dominant M2 MCA, vertebral artery (VA) or basilar artery (BA) on CTA or MRA. 6. Evidence of dissection in the extra or intracranial cerebral arteries. 7. Evidence of bilateral acute stroke or acute stroke in multiple territories (e.g., bilateral anterior circulation, anterior/posterior circulation). 8. Prior stroke in the last 3 months. 9. Anticipated inability to obtain 3-month follow-up assessments. 10. Females who are pregnant or breastfeeding. 11. Renal failure with serum creatinine \>3.0 or Glomerular Filtration Rate (GFR) \<30. 12. Pre-procedural severe sustained hypertension with SBP \>220 and/or DBP \>120. 13. Pre-procedural glucose \<50 mg/dl (2.78 mmol/L) or \>400 mg/dl (22.20 mmol/L). 14. Pre-procedural coagulation factor deficiency or oral anti-coagulant therapy with an international normalized ratio (INR) of more than 1.7. 15. Treatment with heparin within 48 hours with a partial thromboplastin time more than two times the laboratory normal. 16. Treatment with a direct oral anticoagulant (DOAC) within 48 hours. 17. Platelet count of less than 50,000/uL. 18. History of severe allergy to contrast medium, nickel, or Nitinol. 19. Known current use of cocaine at time of treatment. 20. Known or suspected cerebral vasculitis. 21. Known hemorrhagic diathesis. 22. Aneurysm in target vessel. 23. Intracranial tumor (apart from small meningioma, ≤2 cm in diameter). 24. Ongoing seizure due to stroke. 25. Evidence of active systemic infection. 26. Known cancer with metastases. 27. Suspicion of aortic dissection, septic embolus, or bacterial endocarditis. 28. Subject already participating in another study of an investigational treatment device or treatment.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Acute ischemic stroke due to primary distal vessel occlusion are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

cerebral artery occlusion ischemic stroke Neovascularization, Pathologic

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ischemic stroke Neovascularization

Contacts and locations

Locations

Advocate Aurora Research Institute,

Chicago, Illinois, 60657, United States
Alfreid Krupp

Essen, Germany
CUB Hôpital Erasme

Brussels, 1070, Belgium
Corewell Health (Spectrum)

Grand Rapids, Michigan, 49085, United States
Lakewood Regional Medical Center

Los Angeles, California, 90013, United States
Los Robles

Thousand Oaks, California, 91360, United States
Mercy Health

Toledo, Ohio, 43604, United States
Mount Sinai

New York, New York, 10029, United States
Munson Medical Center

Traverse City, Michigan, 49684, United States
NYU Langone Health

New York, New York, 10016, United States
Orebro University Hospital

Örebro, Sweden
Semmes Murphey Foundation

Memphis, Tennessee, 38120, United States
St. Lukas hospital, Radprax

Solingen, Solingen, 42697, Germany
Stony Brook University

Stony Brook, New York, 11794, United States
Texas Stroke Institute

Plano, Texas, 75075, United States
University of Buffalo

Buffalo, New York, 14203, United States
Universitätsklinikum Bonn

Bonn, 53127, Germany
Universitätsklinikum Schleswig-Holstein

Kiel, Germany
Valley Baptist Medical Center

Harlingen, Texas, 78550, United States
WellStar Research Institute

Marietta, Georgia, 30060, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.