Distal Ischemic Stroke Treatment With Adjustable Low-profile Stentriever

Running, not enrolling · Not applicable

Conditions studied: Ischemic Stroke, Neovascularization

In brief

The objective of the DISTALS Study is to evaluate the safety and effectiveness of the Tigertriever 13 Revascularization Device in restoring blood flow in the neurovasculature by removing thrombus in patients presenting within 24 hours of onset with an ischemic stroke with disabling neurological deficits due to a primary distal vessel occlusion (DVO), as compared to medical management.

Key facts

Study ID

NCT05152524

Run by

Rapid Medical

People needed

168

Starts

2022-03-25

Expected to finish

2026-03-01

Last updated by the study team

2025-12-22

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18-85 years old.
• Pre-stroke mRS ≤2.
• 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.
• NIHSS 4-24, or NIHSS 2-24 for patients with aphasia and/or hemianopia.
• 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.
• Occluded distal vessel diameter ≥1.5 mm as measured on CTA or MRA.
• Ischemic core lesion (rCBF<30% on CTP or ADC <620 on MR DWI) in ≤50% of the perfusion lesion volume.
• Study treatment can be initiated within 24 hours of last known well time (last known time without current stroke symptoms).
• Signed informed consent by patient or legally authorized representative.
• 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.)

You may not qualify if…

• Evidence of acute brain hemorrhage on CT and/or MRI at admission.
• Use of any other intra-arterial (IA) recanalization device prior to the Tigertriever 13 in the target vessel, including aspiration catheter.
• The DVO is a secondary distal occlusion that occurred during a large vessel occlusion (LVO) thrombectomy procedure.
• 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.
• 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.
• Evidence of dissection in the extra or intracranial cerebral arteries.
• Evidence of bilateral acute stroke or acute stroke in multiple territories (e.g., bilateral anterior circulation, anterior/posterior circulation).
• Prior stroke in the last 3 months.
• Anticipated inability to obtain 3-month follow-up assessments.
• Females who are pregnant or breastfeeding.
• Renal failure with serum creatinine >3.0 or Glomerular Filtration Rate (GFR) <30.
• Pre-procedural severe sustained hypertension with SBP >220 and/or DBP >120.
• Pre-procedural glucose <50 mg/dl (2.78 mmol/L) or >400 mg/dl (22.20 mmol/L).
• Pre-procedural coagulation factor deficiency or oral anti-coagulant therapy with an international normalized ratio (INR) of more than 1.7.
• Treatment with heparin within 48 hours with a partial thromboplastin time more than two times the laboratory normal.
• Treatment with a direct oral anticoagulant (DOAC) within 48 hours.
• Platelet count of less than 50,000/uL.
• History of severe allergy to contrast medium, nickel, or Nitinol.
• Known current use of cocaine at time of treatment.
• Known or suspected cerebral vasculitis.
• Known hemorrhagic diathesis.
• Aneurysm in target vessel.
• Intracranial tumor (apart from small meningioma, ≤2 cm in diameter).
• Ongoing seizure due to stroke.
• Evidence of active systemic infection.

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.