Comparing stenting and non-stenting approaches for acute ischemic stroke treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of intra-arterial mechanical thrombectomy combined with either acute carotid stenting or a non-stenting approach in patients suffering from acute ischemic stroke due to proximal carotid artery occlusion. Participants will be randomly assigned to one of two groups: one receiving stenting and the other receiving best medical management with thrombectomy without stenting. The study will follow patients for outcomes at three months and one year post-treatment, ensuring an independent assessment of results. The trial is designed to provide insights into the optimal management of acute ischemic strokes related to carotid artery occlusions.

Why it matters

Who can join: the full rules

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)

Where it's running

• Mobile Infirmary Medical Center
  Mobile, Alabama, United States Recruiting
• Adventist health
  Glendale, California, United States Recruiting
• University of California, Irvine
  Irvine, California, United States Recruiting
• Pomona Valley
  Pomona, California, United States Recruiting
• Sutter Institute for Medical Research
  Sacramento, California, United States Recruiting
• California Pacific Medical Center/Mils Peninsula Medical Center
  San Francisco, California, United States Recruiting

+10 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Osama O Zaidat, MD, MS — Mercy Health St. Vincent Medical Center
• Study coordinator: Jasmine M Olvany, PhD
• Email: jolvany@mercy.com
• Phone: (419)-251-4264

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.