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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Mechanical thrombectomy with Tigertriever 13 EVT + MM (without thrombolysis). |
|
| Control | No Intervention | Medical Management alone (without thrombolysis). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tigertriever 13 | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| All cause mortality at 90 days. | All cause mortality at 90 days. | 90 days post randomization. |
| Any asymptomatic intracranial hemorrhage within 24±6 hours of randomization. | Any asymptomatic intracranial hemorrhage within 24±6 hours of randomization. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lakewood Regional Medical Center | Los Angeles | California | 90013 | United States | ||
| Los Robles |
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| 24±6 hours of randomization. |
| Device/procedure related serious adverse events (SAEs). | Device/procedure related serious adverse events (SAEs). | 90 days post randomization. |
| Unanticipated adverse device effect (UADEs). | Unanticipated adverse device effect (UADEs). | During procedure |
| 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. |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| CUB Hôpital Erasme | Brussels | 1070 | Belgium |
| Universitätsklinikum Bonn | Bonn | 53127 | Germany |
| Alfreid Krupp | Essen | Germany |
| Universitätsklinikum Schleswig-Holstein | Kiel | Germany |
| St. Lukas hospital, Radprax | Solingen | 42697 | Germany |
| Orebro University Hospital | Örebro | Sweden |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D009389 | Neovascularization, Pathologic |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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