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

Launched by MERCY HEALTH OHIO · Nov 2, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a treatment for patients who have experienced an acute ischemic stroke, which is caused by a blockage in a blood vessel that supplies the brain. The trial aims to find out if a specific procedure, called intra-arterial mechanical thrombectomy combined with stenting, is more effective than other approaches for patients with blockages in both the carotid artery and the brain's blood vessels. Participants will be randomly assigned to one of the treatment options, and the study is currently looking for individuals aged 18 to 79 who show symptoms of stroke and have certain imaging results indicating a blockage.

To be eligible for the trial, participants must have experienced stroke symptoms and meet specific imaging criteria that show significant artery blockages. They should be able to start treatment within 16 hours of their stroke onset and have a good level of function before the stroke occurred. Participants can expect to receive one of the two treatments and will be closely monitored throughout the trial. It’s important to know that certain health conditions or medications may prevent someone from participating, and those interested will need to provide informed consent before joining the study.

Gender

ALL

Eligibility criteria

• 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)