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Recruiting NCT07356284

Emergent Large Vessel Occlusion Endovascular Rescue Therapy With Underlying Intracranial Stenosis

Phase III Interventional Brain Stroke Stenting Treatment Acute Ischemic Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mechanical Thrombectomy plus adjunct stenting, Mechanical Thrombectomy.
Who it may be relevant to
Registry conditions: Brain Stroke, Stenting Treatment, Acute Ischemic Stroke. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Procedure Mechanical Thrombectomy plus adjunct stenting
    Mechanical thrombectomy and adjunct stentiing
  • Device Mechanical Thrombectomy
    Mechanical thrombectomy only

Primary outcome measures

  • Primary Efficacy Endpoint [Time frame: 90 (+/- 30) days post treatment]
  • Primary Safety Endpoint [Time frame: 90 (+/- 30 ) days post treatment]
Secondary outcome measures (10)
  • Secondary Safety Endpoint [Time frame: 8 (+/- 3) days or Discharge post treatment]
  • Secondary Safety Endpoint [Time frame: Immediate post treatment]
  • Secondary Safety Endpoint [Time frame: Immediate post treatment]
  • Secondary Safety Endpoint [Time frame: Immediate post treatment]
  • Secondary Safety Endpoint [Time frame: 1 year (+/- 60) days post treatment]
  • Secondary Safety Endpoint [Time frame: Immediate post treatment]
  • Secondary Safety Endpoint [Time frame: 1 year (+/- 60) days post treatment]
  • Secondary Safety Endpoint [Time frame: 1 year (+/- 60) days post treatment]
  • Secondary Safety Endpoints [Time frame: 1 year (+/- 60) days post treatment]
  • Secondary Safety Endpoint [Time frame: 1 year (+/- 60) days post treatment]

Eligibility criteria

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
  • 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 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:
  • 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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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • ProMedica Toledo Hospital — Toledo

Identifiers

NCT: NCT07356284 · EVEREST

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗