Emergent Large Vessel Occlusion Endovascular Rescue Therapy With Underlying Intracranial Stenosis (NCT07356284) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Emergent Large Vessel Occlusion Endovascular Rescue Therapy With Underlying Intracranial Stenosis
342 participantsStarted 2026-06-01
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 18 to 80 years of age
✓. Presenting with symptoms consistent with AIS
✓. 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
✓. NIHSS ≥ 6
✓. Ability to randomize within 24 hours of stroke onset.
✓. Pre-stroke mRS score 0-2
✓. Ability to obtain signed informed consent.
✓. ASPECTS Score ≥ 6 by non-contrast CT scan
Exclusion criteria
✕. Females who are pregnant, or those of child-bearing potential with positive urine or serum beta Human Chorionic Gonadotropin (HCG) test
✕. Known severe allergy (more than a rash) to contrast media uncontrolled by medications.
✕. CT evidence of the following conditions:
✕. Acute bilateral strokes
✕. Contraindication to antiplatelet (aspirin, clopidogrel, ticagrelor, cangrelor) or contrast agents
✕. 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
✕. 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
✕. Baseline platelet count \<80,000 per microliter (µl)