Distal Ischemic Stroke Treatment With Adjustable Low-profile Stentriever (DISTALS)

Rapid Medical

Status: Enrolling

Conditions: Ischemic Stroke; Neovascularization

Treatments: Device: Tigertriever 13

Study type: Interventional

Funder types: Industry

Identifiers

NCT05152524

CLN-TR13-001

Details and patient eligibility

About

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.

Enrollment: 168 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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168 participants in 2 patient groups

Treatment

Experimental group

Description:

Mechanical thrombectomy with Tigertriever 13 EVT + MM (without thrombolysis).

Treatment:

Device: Tigertriever 13

Control

No Intervention group

Description:

Medical Management alone (without thrombolysis).