Brain StrokePhase 3EVERESTNCT07356284
Emergent Large Vessel Occlusion Endovascular Rescue Therapy With Underlying Intracranial Stenosis
A Phase 3 study testing Mechanical Thrombectomy plus adjunct stenting and Mechanical Thrombectomy in people with Brain Stroke and Stenting Treatment, run by ProMedica Health System at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Brain Stroke, Stenting Treatment, Acute Ischemic Stroke
- What is being tested?
- Mechanical Thrombectomy plus adjunct stenting and Mechanical Thrombectomy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 342 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2026to 1 Jun 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mouhammad Jumaa, MD contact
United States1 site, 1 recruiting
- Recruiting
ProMedica Toledo Hospital
Toledo, Ohio, 43606
Kathryn Scalzo, 4192914068, Kathryn.Scalzo@ProMedica.org
Scalzo
About this study
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
- Being tested
- Mechanical Thrombectomy plus adjunct stenting, Mechanical Thrombectomy
- Keywords
- mechanical thrombectomy, Acute Ischemic stroke
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical Thrombectomy plus adjunct stentingProcedure or surgery
Also called mechanical thrombectomy, Stenting
Mechanical thrombectomy and adjunct stentiing
Mechanical ThrombectomyDevice
Mechanical thrombectomy only
| Study group | Role | What they receive |
|---|---|---|
| Randomized to Mechanical Thrombectomy (MT) plus adjunct Stenting | Experimental | Patients will have mechanical thrombectomy (MT) and stenting Receives: Procedure: Mechanical Thrombectomy plus adjunct stenting |
| Randomized to Mechanical Thrombectomy (MT) | Active comparator | Patients will only have mechanical thrombectomy (MT) done Receives: Device: Mechanical Thrombectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy Endpoint
- Utility weighted 90-day Modified Rankin Score (mRS)
Measured: 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)
Measured: 90 (+/- 30 ) days post treatment
Secondary outcomes (10)
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).
Measured: 8 (+/- 3) days or Discharge post treatment
Secondary Safety Endpoint
Embolization into new territory (ENT)
Measured: Immediate post treatment
Secondary Safety Endpoint
Distal embolization (DE)
Measured: Immediate post treatment
Secondary Safety Endpoint
Major vessel injury (perforation, dissection)
Measured: Immediate post treatment
Secondary Safety Endpoint
Ipsilateral recurrent stroke in the territory of the index artery from Day 1 through 1-year
Measured: 1 year (+/- 60) days post treatment
Secondary Safety Endpoint
Rates of stent re-stenosis and stent thrombosis at the end of endovascular procedure
Measured: Immediate post treatment
Secondary Safety Endpoint
- Intracranial stent stenosis (WASID) and stent thrombosis at any time between Day 1 to one year follow up
Measured: 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)
Measured: 1 year (+/- 60) days post treatment
Secondary Safety Endpoints
Neurological and All-Cause Mortality at 90 days and 1-year
Measured: 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.
Measured: 1 year (+/- 60) days post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start19 May 2026
- Primary completion1 Jun 2030 (estimated)
- Study completion1 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 342 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ProMedica Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sami Al Kasab, MD, Principal investigator, Medical University of South CarolinaMouhammad Jumaa, MD, Principal investigator, ProMedica Toledo HospitalTanya Siddiqui, Study director, ProMedica Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07356284
- Sponsor's protocol ID
- EVEREST
- Acronym
- EVEREST
- Status last verified
- Feb 2026
- First submitted
- 20 Jan 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergent Large Vessel Occlusion Endovascular Rescue Therapy With Underlying Intracranial Stenosis
- ClinicalTrials.gov ID
- NCT07356284
- Acronym / sponsor ID
- EVEREST / EVEREST
- Conditions
- Brain Stroke, Stenting Treatment, Acute Ischemic Stroke
- Keywords
- mechanical thrombectomy, Acute Ischemic stroke
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 342 participants (estimated)
- Lead sponsor
- ProMedica Health SystemUniversity, hospital or other
- Study start
- 19 May 2026 (actual)
- Primary completion
- 1 Jun 2030 (estimated)
- Study completion
- 1 Jun 2030 (estimated)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Randomized to Mechanical Thrombectomy (MT) plus adjunct Stenting | Experimental | Procedure: Mechanical Thrombectomy plus adjunct stentingPatients will have mechanical thrombectomy (MT) and stenting |
| Randomized to Mechanical Thrombectomy (MT) | Active comparator | Device: Mechanical ThrombectomyPatients will only have mechanical thrombectomy (MT) done |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (18 listed)
- 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:
- Acute bilateral strokes
- Contraindication to antiplatelet (aspirin, clopidogrel, ticagrelor, cangrelor) or contrast agents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mechanical Thrombectomy plus adjunct stentingAlso: mechanical thrombectomy, StentingMechanical thrombectomy and adjunct stentiing | Procedure or surgery | Randomized to Mechanical Thrombectomy (MT) plus adjunct Stenting |
| Mechanical ThrombectomyMechanical thrombectomy only | Device | Randomized to Mechanical Thrombectomy (MT) |
Primary outcome
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)
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mouhammad Jumaa, MD contact
Sami Al Kasab, MD principal investigator
Medical University of South Carolina
Mouhammad Jumaa, MD principal investigator
ProMedica Toledo Hospital
Tanya Siddiqui study director
ProMedica Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mechanical Thrombectomy plus adjunct stenting and Mechanical Thrombectomy in people with Brain Stroke and Stenting Treatment, run by ProMedica Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sami Al Kasab, MD (4192913498, alkasab@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Efficacy Endpoint (time frame: 90 (+/- 30) days post treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.