Distal Ischemic Stroke Treatment With Adjustable Low-profile Stentriever
NCT ID: NCT05152524
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
168 participants
INTERVENTIONAL
2022-03-25
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Treatment
Mechanical thrombectomy with Tigertriever 13 EVT + MM (without thrombolysis).
Tigertriever 13
patients presenting within 24 hours of onset with an ischemic stroke with disabling neurological deficits due to a primary distal vessel occlusion (DVO) will be treated with the Tigertriever 13 device.
Control
Medical Management alone (without thrombolysis).
No interventions assigned to this group
Interventions
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Tigertriever 13
patients presenting within 24 hours of onset with an ischemic stroke with disabling neurological deficits due to a primary distal vessel occlusion (DVO) will be treated with the Tigertriever 13 device.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
85 Years
ALL
No
Sponsors
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Rapid Medical
INDUSTRY
Responsible Party
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Locations
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Lakewood Regional Medical Center
Los Angeles, California, United States
Los Robles
Thousand Oaks, California, United States
WellStar Research Institute
Marietta, Georgia, United States
Advocate Aurora Research Institute,
Chicago, Illinois, United States
Corewell Health (Spectrum)
Grand Rapids, Michigan, United States
Munson Medical Center
Traverse City, Michigan, United States
University of Buffalo
Buffalo, New York, United States
NYU Langone Health
New York, New York, United States
Mount Sinai
New York, New York, United States
Stony Brook University
Stony Brook, New York, United States
Mercy Health
Toledo, Ohio, United States
Semmes Murphey Foundation
Memphis, Tennessee, United States
Valley Baptist Medical Center
Harlingen, Texas, United States
Texas Stroke Institute
Plano, Texas, United States
CUB Hôpital Erasme
Brussels, , Belgium
Universitätsklinikum Bonn
Bonn, , Germany
Alfreid Krupp
Essen, , Germany
Universitätsklinikum Schleswig-Holstein
Kiel, , Germany
St. Lukas hospital, Radprax
Solingen, , Germany
Orebro University Hospital
Örebro, , Sweden
Countries
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Other Identifiers
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CLN-TR13-001
Identifier Type: -
Identifier Source: org_study_id