NCT07356284 Emergent Large Vessel Occlusion Endovascular Rescue Therapy With Underlying Intracranial Stenosis
| NCT ID | NCT07356284 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | ProMedica Health System |
| Condition | Brain Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 342 participants |
| Start Date | 2026-05-19 |
| Primary Completion | 2030-06-01 |
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 342 participants in total. It began in 2026-05-19 with a primary completion date of 2030-06-01.
⚠ 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 study objective is to establish the safety and efficacy of endovascular adjunct stenting for patients undergoing mechanical thrombectomy (MT) that are found to have residual stenosis (70-99%) following attempted clot retrieval with either aspiration catheters or stent retrievers, per device instructions for use and device labeling.
Eligibility Criteria
Inclusion Criteria: 1. 18 to 80 years of age 2. Presenting with symptoms consistent with AIS 3. Imaging evidence of an anterior occlusion of the Internal Carotid Artery (ICA) or Middle Cerebral Artery Main Stem (MCA M1), or proximal M2 segment AND residual 70-99% stenosis of the index artery following attempted clot retrieval with either aspiration catheters or stent retrievers, per device instructions for use and device labeling 4. NIHSS ≥ 6 5. Ability to randomize within 24 hours of stroke onset. 6. Pre-stroke mRS score 0-2 7. Ability to obtain signed informed consent. 8. ASPECTS Score ≥ 6 by non-contrast CT scan 9. Score-ICAD score of ≥11 points at screening and/or persistent stenotic occlusion of ≥70% after MT 10. If indicated, thrombolytic therapy shall be initiated per the institution's usual care and the most recent version of the AHA/ASA Guidelines. Subjects eligible for IV thrombolysis should receive it without delay. 11. For subjects presenting \>6 hours from stroke onset, infarct core volume \<50 cc quantified by CTP 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. CT evidence of the following conditions: * Midline shift or herniation * Evidence of intracranial hemorrhage * Mass effect with effacement of the ventricles 4. Acute bilateral strokes 5. Contraindication to antiplatelet (aspirin, clopidogrel, ticagrelor, cangrelor) or contrast agents 6. Intracranial tumors other than small meningioma, that do not require surgery for at least one year post randomization. Small meningioma is defined as a lesion measuring ≤20mm in maximum diameter or ≤4cm3 in volume, with no associated mass effect, peritumoral edema, or progressive neurological symptoms 7. Known hemorrhagic diathesis, coagulation factor deficiency, or on anticoagulant therapy with an International Normalized Ratio (INR) of \>3.0 or Partial Thromboplastin Time (PTT) \>3 times of normal 8. Baseline platelet count \<80,000 per microliter (µl) 9. Life expectancy less than one year prior to stroke onset 10. Participation in another randomized clinical trial that could confound the evaluation of the study outcomes. 11. 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 12. New diagnosis of atrial fibrillation or a history of atrial fibrillation 13. Suspected device-induced vasospasm defined as smooth transient narrowing of the target vessel 14. Vessel dissection including any of the following: presence of dissection flap, false lumen, contrast stagnation in the vessel wall, and/or improving stenosis \-
Contact & Investigator
Sami Al Kasab, MD
PRINCIPAL INVESTIGATOR
Medical University of South Carolina
Frequently Asked Questions
Who can join the NCT07356284 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Brain 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 NCT07356284 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 342 participants.
Is NCT07356284 currently recruiting?
Yes, NCT07356284 is actively recruiting participants. Contact the research team at alkasab@musc.edu for enrollment information.
Where is the NCT07356284 trial being conducted?
This trial is being conducted at Toledo, United States.
Who is sponsoring the NCT07356284 clinical trial?
NCT07356284 is sponsored by ProMedica Health System. The principal investigator is Sami Al Kasab, MD at Medical University of South Carolina. The trial plans to enroll 342 participants.
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