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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05152524
Other study ID # CLN-TR13-001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 25, 2022
Est. completion date August 2024

Study information

Verified date March 2024
Source Rapid Medical
Contact Walid Haddad, Dr.
Phone +972 72 2503331
Email walid@rapid-medical.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 168
Est. completion date August 2024
Est. primary completion date August 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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.

Study Design


Intervention

Device:
Tigertriever 13
patients presenting within 24 hours of onset with an ischemic stroke with disabling neurological deficits due to a primary distal vessel occlusion (DVO) will be treated with the Tigertriever 13 device.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Rapid Medical

Countries where clinical trial is conducted

United States,  Belgium,  Germany,  Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Successful reperfusion (CTP or MR PWI*) without sICH**. *Successful reperfusion is defined as >50% reduction in substantial hypoperfusion (Tmax >4 seconds) volume between baseline and 24 ±6 hours of randomization.
**sICH shall be defined as any parenchymal hematoma type 2, remote intracerebral hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage that is the predominant cause of =4 point NIHSS deterioration at 24 ±6 hours of randomization.
24±6 Hours post randomization
Secondary All cause mortality at 90 days. All cause mortality at 90 days. 90 days post randomization.
Secondary Any asymptomatic intracranial hemorrhage within 24±6 hours of randomization. Any asymptomatic intracranial hemorrhage within 24±6 hours of randomization. 24±6 hours of randomization.
Secondary Device/procedure related serious adverse events (SAEs). Device/procedure related serious adverse events (SAEs). 90 days post randomization.
Secondary Unanticipated adverse device effect (UADEs). Unanticipated adverse device effect (UADEs). During procedure
Secondary Volume of penumbral tissue salvaged at 24±6 hours of randomization (CTP or MR DWI/PWI). Volume of penumbral tissue salvaged at 24 ±6 hours of randomization (CTP or MR DWI/PWI). 24±6 hours post randomization.
Secondary 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). 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). 24±6 hours post randomization
Secondary Successful reperfusion (eTICI =2b50) rate in the distal occluded vessel after Tigertriever 13 mechanical thrombectomy (assessed in Treatment arm only). Successful reperfusion (eTICI =2b50) rate in the distal occluded vessel after Tigertriever 13 mechanical thrombectomy (assessed in Treatment arm only). 24±6 hours Post procedure
Secondary modified Rankin Scale (mRS) score Level of global disability at 90 days measured by the modified Rankin Scale (mRS) shift (tetrachotomized: 0, 1, 2, 3-6). Minimum score: 0; Maximum score: 6. Lower scores reflects a better clinical outcome, and higher scores reflects worse clinical outcome. 90 days post randomization
Secondary National Institutes of Health Stroke Scale (NIHSS) shift NIHSS change from Baseline to Day 4. Minimum score: 0; Maximum score: 42. Lower scores reflects a better clinical outcome, and higher scores reflects worse clinical outcome. 4 days post procedure
Secondary EQ-5D score Health-related quality of life at 90 days - EQ-5D. Minimum score: 1; Maximum score: 9. Lower scores reflects a better clinical outcome, and higher scores reflects worse clinical outcome. 90 days post randomization
Secondary MoCA: Montreal Cognitive Assessment Cognitive function at 90 days. Minimum score: 0; Maximum score: 30. Higher scores reflects a better clinical outcome, and Lower scores reflects worse clinical outcome. 90 days post randomization
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