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Phase 3Recruiting

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

Sponsored by Mercy Health Ohio

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).

Independent Investigator-initiated, designed and conducted non-industry study. A prospective, phase III, randomized, open-label, blinded-endpoint controlled trial (PROBE Design). Patients presenting with symptoms of AIS in the anterior circulation with proximal carotid occlusion or severe stenosis will be assigned to either: ARM1 (Control): Non-stenting group constitutes best medical management (BMM)+intra-arterial treatment (IAT) with mechanical thrombectomy (for IVO) added to extra-cranial proximal carotid occlusion treatment with non-stenting approach (MT+CAT) VERSUS ARM2 (Intervention): Acute carotid stenting (ACS) approach constitutes BMM+IAT with acute carotid stenting (ACS) of the extracranial proximal carotid artery, spanning the cervical internal carotid artery (ICA), ICA orig…

Where this study is enrolling (51)

Show all 51 locations
Who can participate

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)

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.