NCT07356284 · ProMedica Health System
Emergent Large Vessel Occlusion Endovascular Rescue Therapy With Underlying Intracranial Stenosis
(EVEREST)
What this study is about
The study objective is to establish the safety and effectiveness 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.
View original scientific description
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
• Utility weighted 90-day Modified Rankin Score (mRS)
Primary Safety Endpoint
Time frame: 90 (+/- 30 ) days post treatment
Rate of symptomatic intracranial hemorrhage (sICH: Parenchymal hematoma Type 2 (PH2) with ≥4 points NIHSS worsening) at 24 hours (-12/+16 hours) from randomization)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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 \-
Where
- Toledo, Ohio
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 22, 2026 · Source of record for eligibility and locations