NCT05611242 Proximal Internal Carotid Artery Acute Stroke Secondary to Tandem or Local Occlusion Thrombectomy Trial
| NCT ID | NCT05611242 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Mercy Health Ohio |
| Condition | Acute Ischemic Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 404 participants |
| Start Date | 2024-05-08 |
| Primary Completion | 2028-03-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 404 participants in total. It began in 2024-05-08 with a primary completion date of 2028-03-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
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)
Contact & Investigator
Osama O Zaidat, MD, MS
PRINCIPAL INVESTIGATOR
Mercy Health St. Vincent Medical Center
Frequently Asked Questions
Who can join the NCT05611242 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 79 Years, studying Acute Ischemic Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05611242 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 404 participants.
Is NCT05611242 currently recruiting?
Yes, NCT05611242 is actively recruiting participants. Contact the research team at jolvany@mercy.com for enrollment information.
Where is the NCT05611242 trial being conducted?
This trial is being conducted at Mobile, United States, Glendale, United States, Irvine, United States, Pomona, United States and 11 additional locations.
Who is sponsoring the NCT05611242 clinical trial?
NCT05611242 is sponsored by Mercy Health Ohio. The principal investigator is Osama O Zaidat, MD, MS at Mercy Health St. Vincent Medical Center. The trial plans to enroll 404 participants.
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