RECRUITING

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

Description

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).

Study Overview

Study Details

Study overview

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).

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

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

Condition
Acute Ischemic Stroke
Intervention / Treatment

-

Contacts and Locations

Mobile

Mobile Infirmary Medical Center, Mobile, Alabama, United States, 36607

Pomona

Pomona Valley, Pomona, California, United States, 91767

Sacramento

Sutter Institute for Medical Research, Sacramento, California, United States, 95816

San Francisco

California Pacific Medical Center/Mils Peninsula Medical Center, San Francisco, California, United States, 94107

Coral Gables

Baptist Health South Florida, Coral Gables, Florida, United States, 33143

Delray Beach

Delray Medical Center, Delray Beach, Florida, United States, 33484

Orlando

Orlando Health, Inc., Orlando, Florida, United States, 32806

Tampa

University of South Florida, Tampa, Florida, United States, 33606

Marietta

WellStar Health System, Inc, Marietta, Georgia, United States, 30062

Chicago

Ascension/Alexian Brothers Health System, Chicago, Illinois, United States, 60606

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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:
  • 10. Must be ineligible for IV t-PA therapy or have failed IV t-PA therapy
  • 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)

Ages Eligible for Study

18 Years to 79 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Mercy Health Ohio,

Osama O Zaidat, MD, MS, PRINCIPAL_INVESTIGATOR, Mercy Health St. Vincent Medical Center

Study Record Dates

2027-05-08