Treatment for ischemic stroke using a new stentriever device

Distal Ischemic Stroke Treatment With Adjustable Low-profile Stentriever

This study is testing a new device to see if it can help restore blood flow in people who have had an ischemic stroke caused by a blocked blood vessel.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 168 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Rapid Medical (industry)
• Locations: 25 sites (Phoenix, Arizona and 24 other locations)
• Trial ID: NCT05152524 on ClinicalTrials.gov

What this trial studies

The DISTALS Study aims to assess the safety and effectiveness of the Tigertriever 13 Revascularization Device in restoring blood flow in patients suffering from ischemic stroke due to distal vessel occlusion. Participants will be treated within 24 hours of symptom onset, and the study will compare the outcomes of this device against standard medical management. The focus is on patients with disabling neurological deficits, ensuring that the intervention targets those most in need of immediate care.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-85 with disabling deficits from an ischemic stroke and specific imaging criteria indicating a distal vessel occlusion.

Not a fit: Patients with non-disabling strokes or those who do not meet the specific imaging and clinical criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve recovery outcomes for patients suffering from ischemic strokes caused by distal vessel occlusions.

How similar studies have performed: Other studies have shown promise in using similar devices for stroke treatment, indicating a potential for success in this approach.

Eligibility criteria

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.

Where this trial is running

Phoenix, Arizona and 24 other locations

• Honor Health — Phoenix, Arizona, United States (WITHDRAWN)
• Carondelet St. Jospeh's Hospital — Tucson, Arizona, United States (WITHDRAWN)
• Providence Health — Fullerton, California, United States (WITHDRAWN)
• Lakewood Regional Medical Center — Los Angeles, California, United States (RECRUITING)
• Los Robles — Thousand Oaks, California, United States (RECRUITING)
• WellStar Research Institute — Marietta, Georgia, United States (RECRUITING)
• Advocate Aurora Research Institute, — Chicago, Illinois, United States (RECRUITING)
• Corewell Health (Spectrum) — Grand Rapids, Michigan, United States (RECRUITING)
• Munson Medical Center — Traverse City, Michigan, United States (RECRUITING)
• University of Buffalo — Buffalo, New York, United States (RECRUITING)
• NYU Langone Health — New York, New York, United States (RECRUITING)
• Mount Sinai — New York, New York, United States (RECRUITING)
• Stony Brook University — Stony Brook, New York, United States (RECRUITING)
• Mercy Health — Toledo, Ohio, United States (RECRUITING)
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States (WITHDRAWN)
• Semmes Murphey Foundation — Memphis, Tennessee, United States (RECRUITING)
• Valley Baptist Medical Center — Harlingen, Texas, United States (RECRUITING)
• Texas Stroke Institute — Plano, Texas, United States (RECRUITING)
• CUB Hôpital Erasme — Brussels, Belgium (RECRUITING)
• University Hospital Knappschaftskrankenhaus — Bochum, Germany (WITHDRAWN)
• Universitätsklinikum Bonn — Bonn, Germany (RECRUITING)
• Alfreid Krupp — Essen, Germany (RECRUITING)
• Universitätsklinikum Schleswig-Holstein — Kiel, Germany (RECRUITING)
• St. Lukas hospital, Radprax — Solingen, Germany (RECRUITING)
• Orebro University Hospital — Orebro, Sweden (RECRUITING)

Study contacts

• Study coordinator: Walid Haddad, Dr.

Conditions: Ischemic Stroke, Neovascularization