Acute Ischemic Stroke Clinical Trial
— PICASSOOfficial title:
Proximal Internal Carotid Artery Acute Stroke Secondary to Tandem or Local Occlusion Thrombectomy Trial
NCT number | NCT05611242 |
Other study ID # | 0525052522 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | May 1, 2024 |
Est. completion date | May 1, 2026 |
The primary objective is to establish the efficacy of intra-arterial (IA) mechanical thrombectomy (MT) with extracranial proximal carotid artery acute stenting versus non-stenting approaches in patients with acute ischemic stroke (AIS) from intracranial vessel occlusion (IVO) in the anterior circulation and have a proximal carotid occlusive disease (occlusion or severe stenosis).
Status | Recruiting |
Enrollment | 404 |
Est. completion date | May 1, 2026 |
Est. primary completion date | March 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 79 Years |
Eligibility | Inclusion Criteria: 1. 18 to 79 years of age (before the 80th birthday) 2. Presenting with symptoms consistent with AIS 3. Imaging evidence of an anterior circulation occlusion of the Internal Carotid Artery (ICA) terminus and/or Middle Cerebral Artery Main Stem (MCA M1), or proximal M2 segment AND extra-cranial proximal carotid occlusion / severe stenosis related to atherosclerosis requiring treatment on non-invasive imaging =70% 4. NIHSS = 4 5. Ability to randomize and start endovascular therapy within 16 hours of stroke onset 6. Pre-stroke mRS score 0-2 7. Ability to obtain signed informed consent 8. ASPECTS Score =7 via non-contrast CT or MRI (DWI) for subjects =6 hours from stroke onset OR ASPECTS Score =7 + infarct core volume <50 cc quantified by CTP (rCBF<30%) OR <25 cc quantified by MRI-DWI (AxBxC/2) for subjects with endovascular therapy starting between >6h to 16 hours from stroke onset, given the need for antiplatelet therapy. 9. Acute Neurological Deficit with Imaging evidence of Tandem Lesion: Extracranial carotid occlusion (70% to 100% Using NACET criteria) With or without intracranial vascular occlusion 10. Must be ineligible for IV t-PA therapy or have failed IV t-PA therapy Exclusion Criteria: 1. Females who are pregnant, or those of child-bearing potential with positive urine or serum beta Human Chorionic Gonadotropin (HCG) test 2. Known severe allergy (more than a rash) to contrast media uncontrolled by medications 3. Refractory hypertension (defined as persistent systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg) despite medication 4. CT evidence of the following conditions: - Midline shift or herniation - Evidence of intracranial hemorrhage - Mass effect with effacement of the ventricles 5. Acute bilateral strokes 6. Contraindication to antiplatelet (Aspirin, Plavix, Ticagrelor, Cangrelor), or thrombolytic therapy, or contrast agents. 7. Intracranial tumors other than small meningioma that does not require surgery for one year post randomization 8. Known hemorrhagic diathesis, coagulation factor deficiency, or on anticoagulant therapy with an International Normalized Ratio (INR) of >1.7 or Partial Thromboplastin Time (PTT) > 3 times of normal 9. Baseline platelet count <100,000 per microliter (µl) 10. Life expectancy less than one year prior to stroke onset 11. Participation in another randomized clinical trial that could confound the evaluation of the study outcomes 12. Any other condition (in the opinion of the site investigator) that precludes an endovascular procedure or poses a significant hazard to the patient if an endovascular procedure was performed 13. Proximal carotid stenosis secondary to dissection or vasculitis (.e.g. Takayasu's Arteritis) |
Country | Name | City | State |
---|---|---|---|
United States | Mobile Infirmary Medical Center | Mobile | Alabama |
United States | West Virginia Univeristy | Morgantown | West Virginia |
United States | Munster Community Hospital | Munster | Indiana |
United States | SSM Health DePaul Hospital | Saint Louis | Missouri |
United States | University of Utah | Salt Lake City | Utah |
United States | Mercy Health St. Vincent Medical Center | Toledo | Ohio |
Lead Sponsor | Collaborator |
---|---|
Mercy Health Ohio |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 90-day Modified Rankin Scale ordinal shift | Scale used for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Scale ranges from 0-6 where 0 represents no symptoms and 6 represents death. 0 = No symptoms at all. No significant disability despite symptoms; able to carry out all usual duties and activities. Slight disability; unable to carry out all previous activities but able to look after own affairs without assistance. Moderate disability requiring some help, but able to walk without assistance. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance. Severe disability; bedridden, incontinent, and requiring constant nursing care and attention. Death |
Time Frame: 90 days post randomization |
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