RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2024-05-08
Study Completion:2027-05-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05611242

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.

Ages Eligible for Study:18 Years to 79 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. 18 to 79 years of age (before the 80th birthday)
  2. 2. Presenting with symptoms consistent with AIS
  3. 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. 4. NIHSS ≥ 4
  5. 5. Ability to randomize and start endovascular therapy within 16 hours of stroke onset
  6. 6. Pre-stroke mRS score 0-2
  7. 7. Ability to obtain signed informed consent
  8. 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. 9. Acute Neurological Deficit with Imaging evidence of Tandem Lesion:
  10. 10. Must be ineligible for IV t-PA therapy or have failed IV t-PA therapy
  1. 1. Females who are pregnant, or those of child-bearing potential with positive urine or serum beta Human Chorionic Gonadotropin (HCG) test
  2. 2. Known severe allergy (more than a rash) to contrast media uncontrolled by medications
  3. 3. Refractory hypertension (defined as persistent systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg) despite medication
  4. 4. CT evidence of the following conditions:
  5. * Midline shift or herniation
  6. * Evidence of intracranial hemorrhage
  7. * Mass effect with effacement of the ventricles
  8. 5. Acute bilateral strokes
  9. 6. Contraindication to antiplatelet (Aspirin, Plavix, Ticagrelor, Cangrelor), or thrombolytic therapy, or contrast agents.
  10. 7. Intracranial tumors other than small meningioma that does not require surgery for one year post randomization
  11. 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
  12. 9. Baseline platelet count \<100,000 per microliter (μl)
  13. 10. Life expectancy less than one year prior to stroke onset
  14. 11. Participation in another randomized clinical trial that could confound the evaluation of the study outcomes
  15. 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
  16. 13. Proximal carotid stenosis secondary to dissection or vasculitis (.e.g. Takayasu's Arteritis)

Contacts and Locations

Study Contact

Jasmine M Olvany, PhD
CONTACT
(419)-251-4264
jolvany@mercy.com
Laila Ibrahim, MPH
CONTACT
librahim@mercy.com

Principal Investigator

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

Study Locations (Sites)

Mobile Infirmary Medical Center
Mobile, Alabama, 36607
United States
Pomona Valley
Pomona, California, 91767
United States
Sutter Institute for Medical Research
Sacramento, California, 95816
United States
California Pacific Medical Center/Mils Peninsula Medical Center
San Francisco, California, 94107
United States
Baptist Health South Florida
Coral Gables, Florida, 33143
United States
Delray Medical Center
Delray Beach, Florida, 33484
United States
Orlando Health, Inc.
Orlando, Florida, 32806
United States
University of South Florida
Tampa, Florida, 33606
United States
WellStar Health System, Inc
Marietta, Georgia, 30062
United States
Ascension/Alexian Brothers Health System
Chicago, Illinois, 60606
United States
University of Chicago
Chicago, Illinois, 60637
United States
Munster Community Hospital
Munster, Indiana, 46321
United States
Baptist Healthcare Systems, Inc
Lexington, Kentucky, 40299
United States
Louisiana State University Health Sciences Center at Shreveport
Shreveport, Louisiana, 71103
United States
Boston Medical Center
Boston, Massachusetts, 02118
United States
University of Massachusetts
Worcester, Massachusetts, 01655
United States
McLaren Flint
Flint, Michigan, 48532
United States
Bronson Methodist Hospital/Western Michigan University Homer Stryker M.D. School of Medicine
Kalamazoo, Michigan, 49007
United States
Michigan State University
Lansing, Michigan, 48912
United States
McLaren Macomb
Mount Clemens, Michigan, 48043
United States
SSM Health DePaul Hospital
Saint Louis, Missouri, 63044
United States
Rutgers, The State University
Piscataway, New Jersey, 08854
United States
Albany Medical College
Albany, New York, 12208
United States
Northwell Health- South Shore University Hospital
Bay Shore, New York, 11706
United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
United States
Mercy Health St. Vincent Medical Center
Toledo, Ohio, 43608
United States
WellSpan Health
York, Pennsylvania, 17403
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
Semmes-Murphey Foundation
Memphis, Tennessee, 38120
United States
DHR Health Institute for Research and Development
Edinburg, Texas, 78539
United States
HCA Houston Kingwood
Houston, Texas, 77004
United States
University of Utah
Salt Lake City, Utah, 84112
United States
Valley Medical Center
Renton, Washington, 98055
United States
West Virginia Univeristy
Morgantown, West Virginia, 26506
United States

Collaborators and Investigators

Sponsor: Mercy Health Ohio

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-08
Study Completion Date2027-05-08

Study Record Updates

Study Start Date2024-05-08
Study Completion Date2027-05-08

Terms related to this study

Keywords Provided by Researchers

  • Stroke
  • Ischemic Stroke
  • Thrombectomy

Additional Relevant MeSH Terms

  • Acute Ischemic Stroke