Distal Ischemic Stroke Treatment With Adjustable Low-profile Stentriever
United States168 participantsStarted 2022-03-25
Plain-language summary
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.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion criteria
✓. 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).
Exclusion criteria
✕. 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.
What they're measuring
1
Successful reperfusion (CTP or MR PWI*) without sICH**.
✕. 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).