Emergent Large Vessel Occlusion Endovascular Rescue Therapy With Underlying Intracranial Stenosis

NCT07356284 | Not Yet Recruiting Phase 3 DMC FDA Device

• 1 other identifier: EVEREST
• Study Type: interventional
• Target: 342
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Brain Stroke; Stenting Treatment; Acute Ischemic Stroke

Keywords

mechanical thrombectomy; Acute Ischemic stroke

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Secondary Safety Endpoint

  8 (+/- 3) days or Discharge post treatment

• Secondary Safety Endpoint

  Immediate post treatment

• Secondary Safety Endpoint

  Immediate post treatment

• Secondary Safety Endpoint

  Immediate post treatment

• Secondary Safety Endpoint

  1 year (+/- 60) days post treatment

Other Outcomes (11)

• Secondary Efficacy Endpoints

  1 year (+/-60) days post treatment

• Secondary Efficacy Endpoints

  90 (+/-30) days post treatment

• Secondary Efficacy Endpoints

  1 year (+/- 60) days post treatment

Study Arms (2)

Randomized to Mechanical Thrombectomy (MT) plus adjunct Stenting

EXPERIMENTAL

Patients will have mechanical thrombectomy (MT) and stenting

Procedure: Mechanical Thrombectomy plus adjunct stenting

Randomized to Mechanical Thrombectomy (MT)

ACTIVE COMPARATOR

Patients will only have mechanical thrombectomy (MT) done

Device: Mechanical Thrombectomy

Interventions

Mechanical Thrombectomy plus adjunct stenting PROCEDURE

Mechanical thrombectomy and adjunct stentiing

Also known as: mechanical thrombectomy, Stenting

Randomized to Mechanical Thrombectomy (MT) plus adjunct Stenting

Mechanical Thrombectomy DEVICE

Mechanical thrombectomy only

Randomized to Mechanical Thrombectomy (MT)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ProMedica Health System: lead

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Stents

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Officials

• Sami Al Kasab, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

• Mouhammad Jumaa, MD

  ProMedica Toledo Hospital

  PRINCIPAL INVESTIGATOR

• Tanya Siddiqui

  ProMedica Health System

  STUDY DIRECTOR

Central Study Contacts

Sami Al Kasab, MD

CONTACT

4192913498; alkasab@musc.edu

Mouhammad Jumaa, MD

CONTACT

Mouhammad.JumaaMD@ProMedica.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: January 21, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2030
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share