acute ischemic Stroke acute stroke
Conditions
Interventions
The Adaptive Tip Catheter, hereinafter referred to as ATC, is a single lumen, variable stiffness catheter with an 0.070” inner diameter (ID) shaft and a 0.092” ID distal tip. The maximum proximal shaf
Sponsors
Johnson & Johnson
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age = 18 years, = 90 years, at the time of consent 2. Signs and symptoms consistent with the diagnosis of acute ischemic stroke in the anterior circulation that can be treated with endovascular thrombectomy approaches 3. Endovascular treatment can be initiated (defined as access puncture) within 24 hours from time last known well 4. Baseline National Institutes of Health Stroke Scale (NIHSS) score = 6 5. Baseline Alberta Stroke Program Early CT Score (ASPECTS) = 3 6. A signed and dated Informed Consent Form (ICF) or Investigator Statement for emergency procedure (as allowed according to country regulations and approved by EC) has been obtained.
Exclusion criteria
Exclusion criteria: 1. Known pregnancy, as evidenced by positive pregnancy test for women of childbearing potential or breast feeding 2. Life expectancy < 90 days prior to stroke onset 3. Known hemorrhagic diathesis disorder, coagulation factor deficiency or oral anticoagulant therapy with known International Normalized Ratio (INR) >3.0 4. Clinical symptoms and/or CT/MRI evidence suggestive of bilateral stroke or stroke in multiple vascular territories, defined as occlusions in more than one vessel not downstream from each other (e.g. bilateral anterior circulation, anterior/posterior circulation) 5. Clinical history, past imaging or clinical judgement suggest that the intracranial occlusion is chronic 6. CT/MRI evidence of recent/fresh hemorrhage 7. Baseline CT or MRI showing mass effect8. Currently participating in an investigational (drug, device, etc.) clinical trial that may confound study endpoints. Patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible. Cerebral Catheter Angiographic Exclusion Criteria 9. Cerebral catheter angiographic evidence of pre-existing arterial disease, that potentially impacts treatment and/or outcome (e.g., vasculitis) 10. Any occlusion or stenosis that limits device access to the target area (e.g. carotid dissection, tandem occlusions) or requiring acute stenting to achieve access 11. Cerebral catheter angiographic evidence of multiple cerebrovascular occlusions, defined as occlusions in more than one vessel not downstream from each other (e.g. bilateral anterior circulation, anterior/posterior circulation) 12. Excessive vascular access tortuosity that will likely prevent endovascular access with the ATC 13. Baseline eTICI > 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effectiveness : - Third pass reperfusion (eTICI = 2b50 without rescue therapy) as determined by the independent imaging core lab | — |
Secondary
| Measure | Time frame |
|---|---|
| Effectiveness: - First pass reperfusion (eTICI = 2c without rescue therapy) - Final procedural reperfusion (eTICI = 2b50) - Modified Rankin Scale (mRS) 0-2 at 90 days or no change from baseline if pre-ictal mRS >2 Safety: - Vessel damage (vessel dissection and/or vessel perforation) - All-cause mortality at 90 days - Symptomatic Intracranial Hemorrhage (sICH) at 24h per the independent clinical events committee (CEC) | — |
Countries
Belgium, France, Germany, Ireland, Netherlands
Contacts
Public ContactAP Popovici
Johnson & Johnson
Outcome results
None listed