Clinical trial NCT05152524: Distal Ischemic Stroke Treatment With Adjustable Low-profile Stentriever
Official title: Distal Ischemic Stroke Treatment With Adjustable Low-profile Stentriever
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ischemic Stroke
Neovascularization
Lead sponsor: Rapid Medical
Sponsor class: INDUSTRY
First posted: 2021-12-10
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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.

Primary outcomes:
measure: Successful reperfusion (CTP or MR PWI*) without sICH**.
timeFrame: 24±6 Hours post randomization
Secondary outcomes:
measure: All cause mortality at 90 days.
timeFrame: 90 days post randomization.
measure: Any asymptomatic intracranial hemorrhage within 24±6 hours of randomization.
timeFrame: 24±6 hours of randomization.
measure: Device/procedure related serious adverse events (SAEs).
timeFrame: 90 days post randomization.
measure: Unanticipated adverse device effect (UADEs).
timeFrame: During procedure
measure: Volume of penumbral tissue salvaged at 24±6 hours of randomization (CTP or MR DWI/PWI).
timeFrame: 24±6 hours post randomization.
measure: Successful reperfusion at 24 hours, defined as >50% reduction in substantial hypoperfusion (Tmax >4 seconds) volume between baseline and 24 ±6 hours of randomization (assessed in both Treatment and Control arms).
timeFrame: 24±6 hours post randomization
measure: Successful reperfusion (eTICI ≥2b50) rate in the distal occluded vessel after Tigertriever 13 mechanical thrombectomy (assessed in Treatment arm only).
timeFrame: 24±6 hours Post procedure
measure: modified Rankin Scale (mRS) score
timeFrame: 90 days post randomization
measure: National Institutes of Health Stroke Scale (NIHSS) shift
timeFrame: 4 days post procedure
measure: EQ-5D score
timeFrame: 90 days post randomization
measure: MoCA: Montreal Cognitive Assessment
timeFrame: 90 days post randomization
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Honor Health
state: Arizona
city: Tucson
country: United States
facility: Carondelet St. Jospeh's Hospital
state: Arizona
city: Fullerton
country: United States
facility: Providence Health
state: California
city: Los Angeles
country: United States
facility: Lakewood Regional Medical Center
state: California
city: Thousand Oaks
country: United States
facility: Los Robles
state: California
city: Marietta
country: United States
facility: WellStar Research Institute
state: Georgia
city: Chicago
country: United States
facility: Advocate Aurora Research Institute,
state: Illinois
city: Grand Rapids
country: United States
facility: Corewell Health (Spectrum)
state: Michigan
city: Traverse City
country: United States
facility: Munson Medical Center
state: Michigan
city: Buffalo
country: United States
facility: University of Buffalo
state: New York
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: New York
country: United States
facility: Mount Sinai
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University
state: New York
city: Toledo
country: United States
facility: Mercy Health
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Memphis
country: United States
facility: Semmes Murphey Foundation
state: Tennessee
city: Harlingen
country: United States
facility: Valley Baptist Medical Center
state: Texas
city: Plano
country: United States
facility: Texas Stroke Institute
state: Texas
city: Brussels
country: Belgium
facility: CUB Hôpital Erasme
city: Bochum
country: Germany
facility: University Hospital Knappschaftskrankenhaus
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
city: Essen
country: Germany
facility: Alfreid Krupp
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
city: Solingen
country: Germany
facility: St. Lukas hospital, Radprax
city: Orebro
country: Sweden
facility: Orebro University Hospital
Study officials:
References: