ACTIVE_NOT_RECRUITING

Distal Ischemic Stroke Treatment With Adjustable Low-profile Stentriever

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Distal Ischemic Stroke Treatment With Adjustable Low-profile Stentriever

Quick Facts

Study Start:2022-03-25

Study Completion:2026-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05152524

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.)	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.

Inclusion Criteria

Exclusion 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.)

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.

Contacts and Locations

Study Locations (Sites)

Lakewood Regional Medical Center

Los Angeles, California, 90013

United States

Los Robles

Thousand Oaks, California, 91360

United States

WellStar Research Institute

Marietta, Georgia, 30060

United States

Advocate Aurora Research Institute,

Chicago, Illinois, 60657

United States

Corewell Health (Spectrum)

Grand Rapids, Michigan, 49085

United States

Munson Medical Center

Traverse City, Michigan, 49684

United States

University of Buffalo

Buffalo, New York, 14203

United States

NYU Langone Health

New York, New York, 10016

United States

Mount Sinai

New York, New York, 10029

United States

Stony Brook University

Stony Brook, New York, 11794

United States

Mercy Health

Toledo, Ohio, 43604

United States

Semmes Murphey Foundation

Memphis, Tennessee, 38120

United States

Valley Baptist Medical Center

Harlingen, Texas, 78550

United States

Texas Stroke Institute

Plano, Texas, 75075

United States

Collaborators and Investigators

Sponsor: Rapid Medical

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-25

Study Completion Date2026-03

Study Record Updates

Study Start Date2022-03-25

Study Completion Date2026-03

Terms related to this study

Additional Relevant MeSH Terms

Ischemic Stroke
Neovascularization