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

What this study is about

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).

Who can join (things the study team will check)

✅ You may be able to join if…

• 18 to 79 years of age (before the 80th birthday)
• Presenting with symptoms consistent with AIS
• 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%
• NIHSS ≥ 4
• Ability to randomize and start endovascular therapy within 16 hours of stroke onset
• Pre-stroke mRS score 0-2
• Ability to obtain signed informed consent
• 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.
• Acute Neurological Deficit with Imaging evidence of Tandem Lesion: Extracranial carotid occlusion (70% to 100% Using NACET criteria) With or without intracranial vascular occlusion
• Must be ineligible for IV t-PA therapy or have failed IV t-PA therapy

🚫 You may not be able to join if…

• Females who are pregnant, or those of child-bearing potential with positive urine or serum beta Human Chorionic Gonadotropin (HCG) test
• Known severe allergy (more than a rash) to contrast media uncontrolled by medications
• Refractory hypertension (defined as persistent systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg) despite medication
• CT evidence of the following conditions:
  • Midline shift or herniation
  • Evidence of intracranial hemorrhage
  • Mass effect with effacement of the ventricles
• Acute bilateral strokes
• Contraindication to antiplatelet (Aspirin, Plavix, Ticagrelor, Cangrelor), or thrombolytic therapy, or contrast agents.
• Intracranial tumors other than small meningioma that does not require surgery for one year post randomization
• 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
• Baseline platelet count <100,000 per microliter (μl)
• Life expectancy less than one year prior to stroke onset
• Participation in another randomized clinical trial that could confound the evaluation of the study outcomes
• 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
• Proximal carotid stenosis secondary to dissection or vasculitis (.e.g. Takayasu's Arteritis)

Where this trial is running

• Mobile Infirmary Medical Center, Mobile, Alabama, United States
• Glendale Adventist Medical Center, Glendale, California, United States
• University of California, Irvine, Irvine, California, United States
• Pomona Valley, Pomona, California, United States
• Sutter Institute for Medical Research, Sacramento, California, United States
• California Pacific Medical Center/Mils Peninsula Medical Center, San Francisco, California, United States
• Boca Raton - Baptist Health, Boca Raton, Florida, United States
• Delray Medical Center, Delray Beach, Florida, United States
• Baptist Health Research Institute, Jacksonville, Florida, United States
• University of Florida Health Jacksonville, Jacksonville, Florida, United States
• University of Miami School of Medicine, Miami, Florida, United States
• Orlando Health, Inc., Orlando, Florida, United States

+ 39 more sites.

Who to contact

Jasmine M Olvany, PhD · (419)-251-4264 · jolvany@mercy.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT05611242.