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Recruiting NCT05611242

Proximal Internal Carotid Artery Acute Stroke Secondary to Tandem or Local Occlusion Thrombectomy Trial

Conditions: Acute Ischemic Stroke

Sex: All
Ages: 18 Years – 85 Years
Phase: PHASE3
Enrollment: 404
Sponsor: Mercy Health Ohio

Location: United States

Summary

The primary objective is to establish the efficacy of intra-arterial (IA) mechanical thrombectomy with proximal carotid artery angioplasty versus acute stenting during thrombectomy 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) within 24 hours of symptom onset.

Eligibility Criteria

Inclusion Criteria:18 to 85 years of agePresenting with symptoms consistent with AISImaging 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 requiring treatment on non-invasive imaging ≥70%NIHSS ≥ 4Ability to randomize within 24 hours of stroke onsetPre-stroke mRS score 0-2Ability to obtain signed informed consentASPECTS Score ≥ 6 by CT scan or MRI (DWI) ≤6hours from stroke onset, and ASPECT >6 (7-10) OR Core≤50cc on MRP, CTP or MRI >6h-24 hours from stroke onset, given the need for antiplatelet therapyImaging obtained within 24 hours (after the first symptoms or last seen well.Arterial Access Obtained < 25 hours from stroke symptoms onset.Exclusion Criteria:Females who are pregnant, or those of child-bearing potential with positive urine or serum beta Human Chorionic Gonadotropin (HCG) testKnown severe allergy (more than a rash) to contrast media uncontrolled by medicationsRefractory hypertension (defined as persistent systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg) despite medicationCT evidence of the following conditions:Midline shift or herniationEvidence of intracranial hemorrhageMass effect with effacement of the ventriclesAcute bilateral strokesContraindication to antiplatelet (Aspirin, Plavix, Ticagrelor, Cangrelor), or thrombolytic therapy, or contrast agents.Intracranial tumors other than small meningioma that doesn't not require surgery for one year post randomizationKnown hemorrhagic diathesis, coagulation factor deficiency, or on anticoagulant therapy with an International Normalized Ratio (INR) of >3.0 or Partial Thromboplastin Time (PTT) > 3 times of normalBaseline platelet count <30,000 per microliter (µl)Life expectancy less than one year prior to stroke onsetParticipation in another randomized clinical trial that could confound the evaluation of the study outcomesAny 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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05611242). StuddyBuddy aggregates publicly available trial information.