Emergent Large Vessel Occlusion Endovascular Rescue Therapy With Underlying Intracranial Stenosis (EVEREST)

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Ischemic Stroke; Brain Stroke; Stenting Treatment
• Intervention / Treatment: Procedure: Mechanical Thrombectomy plus adjunct stenting; Device: Mechanical Thrombectomy

• Study Type: Interventional
• Enrollment (Estimated): 342
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Mouhammad Jumaa, MD; Email: Mouhammad.JumaaMD@ProMedica.org
• Study Contact Backup: Name: Sami Al Kasab, MD; Phone Number: 4192913498; Email: alkasab@musc.edu

Study Locations

• United States
  • Ohio
    • Toledo, Ohio, United States, 43606
      • Recruiting
      • ProMedica Toledo Hospital
      • Principal Investigator: Mouhammad Jumaa, MD
      • Contact: Kathryn Scalzo; Phone Number: 4192914068; Email: Kathryn.Scalzo@ProMedica.org
      • Contact: Scalzo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

    -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Randomized to Mechanical Thrombectomy (MT) plus adjunct Stenting; Patients will have mechanical thrombectomy (MT) and stenting	Procedure: Mechanical Thrombectomy plus adjunct stenting; Mechanical thrombectomy and adjunct stentiing; Other Names: Stenting; mechanical thrombectomy
Active Comparator: Randomized to Mechanical Thrombectomy (MT); Patients will only have mechanical thrombectomy (MT) done	Device: Mechanical Thrombectomy; Mechanical thrombectomy only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Efficacy Endpoint	• Utility weighted 90-day Modified Rankin Score (mRS)	90 (+/- 30) days post treatment
Primary Safety Endpoint	Rate of symptomatic intracranial hemorrhage (sICH: Parenchymal hematoma Type 2 (PH2) with ≥4 points NIHSS worsening) at 24 hours (-12/+16 hours) from randomization)	90 (+/- 30 ) days post treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Safety Endpoint	Any neurological deterioration with ≥4 points worsening on NIHSS before discharge and unrelated to sICH or sedation (In addition to the routine 24-hour CT/Magnetic Resonance Imaging (MRI) scan, repeat neuroimaging is mandatory for any subsequent neurological deterioration at any time during hospitalization).	8 (+/- 3) days or Discharge post treatment
Secondary Safety Endpoint	Embolization into new territory (ENT)	Immediate post treatment
Secondary Safety Endpoint	Distal embolization (DE)	Immediate post treatment
Secondary Safety Endpoint	Major vessel injury (perforation, dissection)	Immediate post treatment
Secondary Safety Endpoint	Ipsilateral recurrent stroke in the territory of the index artery from Day 1 through 1-year	1 year (+/- 60) days post treatment
Secondary Safety Endpoint	Rates of stent re-stenosis and stent thrombosis at the end of endovascular procedure	Immediate post treatment
Secondary Safety Endpoint	• Intracranial stent stenosis (WASID) and stent thrombosis at any time between Day 1 to one year follow up	1 year (+/- 60) days post treatment
Secondary Safety Endpoint	Intracranial reintervention between Day 1 through 1-year (Any intervention or reintervention will be captured during that period)	1 year (+/- 60) days post treatment
Secondary Safety Endpoints	Neurological and All-Cause Mortality at 90 days and 1-year	1 year (+/- 60) days post treatment
Secondary Safety Endpoint	All serious adverse events (SAE), including serious adverse device events (SADE), serious adverse procedural events (SAPE), and unanticipated SAE.	1 year (+/- 60) days post treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Efficacy Endpoints	Utility weighted one-year Modified Rankin Score (mRS)	1 year (+/-60) days post treatment
Secondary Efficacy Endpoints	90-day and one-year mRS ordinal shift (mRS 5 and 6 combined)	90 (+/-30) days post treatment
Secondary Efficacy Endpoints	90-day and one-year dichotomized mRS 0-2 outcome	1 year (+/- 60) days post treatment
Secondary Efficacy Endpoints	90-day and one-year dichotomized mRS 0-3 outcome	1 year (+/-60) days post treatment
Secondary Efficacy Endpoints	Change in NIHSS at 24 hours (12-40 hours hours) from randomization	Immediate post treatment
Secondary Efficacy Endpoints	Change in NIHSS	Day 8 (+/-3) days or discharge post treatment
Secondary Efficacy Endpoints	NIHSS of 0-2 or improvement of 8 or more points	Day 8 (+/-) 3 days post treatment
Secondary Efficacy Endpoints	Rate of substantial reperfusion in the treatment arm at the end of procedure as TICI2b50 and TICI2b67 or higher	Immediately post treatment
Secondary Efficacy Endpoints	Procedural/time metrics: Door to qualifying image, Image to Puncture, Puncture to mTICI 2b-3, Puncture to end of the procedure (defined as the final angiogram on the affected hemisphere)	Immediate post treatment
Secondary Efficacy Endpoints	Length of hospital stay	Day 8 (+/- 3) days post treatment
Secondary Efficacy Endpoints	Effectiveness of stenting as measured by % stenosis within the MT adjunct stenting arm	1 year (+/-60) days post treatment

Collaborators and Investigators

• Sponsor: ProMedica Health System
• Investigators: Principal Investigator: Sami Al Kasab, MD, Medical University of South Carolina; Principal Investigator: Mouhammad Jumaa, MD, ProMedica Toledo Hospital; Study Director: Tanya Siddiqui, ProMedica Health System

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2026
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2030

Study Registration Dates

• First Submitted: January 20, 2026
• First Submitted That Met QC Criteria: January 20, 2026
• First Posted (Actual): January 21, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: mechanical thrombectomy; Acute Ischemic stroke
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Ischemic Stroke; Equipment and Supplies; Prostheses and Implants; Stents
• Other Study ID Numbers: EVEREST

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes