RecruitingAcute Ischemic Stroke

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

Eligible age

18–79 yrs

Accepts

All genders

Locations

24 states

Healthy volunteers

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About this study

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).

Sponsor: Mercy Health Ohio

You may qualify if…

✓ 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.

You may not qualify if…

✕ 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