RecruitingPhase 3NCT07356284

Emergent Large Vessel Occlusion Endovascular Rescue Therapy With Underlying Intracranial Stenosis

Sponsor

ProMedica Health System

Enrollment

342 participants

Start Date

May 19, 2026

Study Type

INTERVENTIONAL

Conditions

Acute Ischemic Stroke Brain Stroke Stenting Treatment

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria11

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
Score-ICAD score of ≥11 points at screening and/or persistent stenotic occlusion of ≥70% after MT
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.
For subjects presenting >6 hours from stroke onset, infarct core volume <50 cc quantified by CTP

Exclusion Criteria18

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:
Midline shift or herniation
Evidence of intracranial hemorrhage
Mass effect with effacement of the ventricles
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)
Life expectancy less than one year prior to stroke onset
Participation in another randomized clinical trial that could confound the evaluation of the study outcomes.
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
New diagnosis of atrial fibrillation or a history of atrial fibrillation
Suspected device-induced vasospasm defined as smooth transient narrowing of the target vessel
Vessel dissection including any of the following: presence of dissection flap, false lumen, contrast stagnation in the vessel wall, and/or improving stenosis
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