[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07356284":3,"trial-entities:NCT07356284":132,"trial-summary:NCT07356284":135},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":21,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":46,"secondary_outcomes":55,"sex":81,"minimum_age":82,"maximum_age":83,"healthy_volunteers":84,"eligibility_criteria":85,"std_ages":92,"locations":95,"central_contacts":116,"overall_officials":123,"references":130,"see_also_links":131},"NCT07356284","EVEREST","Emergent Large Vessel Occlusion Endovascular Rescue Therapy With Underlying Intracranial Stenosis","RECRUITING","2030-06-01","2026-02","2026-05-22","2026-05-19","ProMedica Health System","OTHER",true,"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.",null,[18,19,20],"Brain Stroke","Stenting Treatment","Acute Ischemic Stroke",[22,23],"mechanical thrombectomy","Acute Ischemic stroke","INTERVENTIONAL","TREATMENT",[27],"PHASE3",{"count":29,"type":30},342,"ESTIMATED",[32,40],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":38},"PROCEDURE","Mechanical Thrombectomy plus adjunct stenting","Mechanical thrombectomy and adjunct stentiing",[37],"Randomized to Mechanical Thrombectomy (MT) plus adjunct Stenting",[22,39],"Stenting",{"type":41,"name":42,"description":43,"armGroupLabels":44},"DEVICE","Mechanical Thrombectomy","Mechanical thrombectomy only",[45],"Randomized to Mechanical Thrombectomy (MT)",[47,51],{"measure":48,"description":49,"timeFrame":50},"Primary Efficacy Endpoint","• Utility weighted 90-day Modified Rankin Score (mRS)","90 (+\u002F- 30) days post treatment",{"measure":52,"description":53,"timeFrame":54},"Primary Safety Endpoint","Rate of symptomatic intracranial hemorrhage (sICH: Parenchymal hematoma Type 2 (PH2) with ≥4 points NIHSS worsening) at 24 hours (-12\u002F+16 hours) from randomization)","90 (+\u002F- 30 ) days post treatment",[56,60,63,65,67,70,72,74,76,79],{"measure":57,"description":58,"timeFrame":59},"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\u002FMagnetic Resonance Imaging (MRI) scan, repeat neuroimaging is mandatory for any subsequent neurological deterioration at any time during hospitalization).","8 (+\u002F- 3) days or Discharge post treatment",{"measure":57,"description":61,"timeFrame":62},"Embolization into new territory (ENT)","Immediate post treatment",{"measure":57,"description":64,"timeFrame":62},"Distal embolization (DE)",{"measure":57,"description":66,"timeFrame":62},"Major vessel injury (perforation, dissection)",{"measure":57,"description":68,"timeFrame":69},"Ipsilateral recurrent stroke in the territory of the index artery from Day 1 through 1-year","1 year (+\u002F- 60) days post treatment",{"measure":57,"description":71,"timeFrame":62},"Rates of stent re-stenosis and stent thrombosis at the end of endovascular procedure",{"measure":57,"description":73,"timeFrame":69},"• Intracranial stent stenosis (WASID) and stent thrombosis at any time between Day 1 to one year follow up",{"measure":57,"description":75,"timeFrame":69},"Intracranial reintervention between Day 1 through 1-year (Any intervention or reintervention will be captured during that period)",{"measure":77,"description":78,"timeFrame":69},"Secondary Safety Endpoints","Neurological and All-Cause Mortality at 90 days and 1-year",{"measure":57,"description":80,"timeFrame":69},"All serious adverse events (SAE), including serious adverse device events (SADE), serious adverse procedural events (SAPE), and unanticipated SAE.","ALL","18 Years","80 Years",false,{"inclusion":86,"exclusion":87,"raw_text":91},[],[88,89,90],"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 \\\u003C80,000 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\u002For improving stenosis","Inclusion Criteria:\n\n1. 18 to 80 years of age\n2. Presenting with symptoms consistent with AIS\n3. 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\n4. NIHSS ≥ 6\n5. Ability to randomize within 24 hours of stroke onset.\n6. Pre-stroke mRS score 0-2\n7. Ability to obtain signed informed consent.\n8. ASPECTS Score ≥ 6 by non-contrast CT scan\n9. Score-ICAD score of ≥11 points at screening and\u002For persistent stenotic occlusion of ≥70% after MT\n10. If indicated, thrombolytic therapy shall be initiated per the institution's usual care and the most recent version of the AHA\u002FASA Guidelines. Subjects eligible for IV thrombolysis should receive it without delay.\n11. For subjects presenting \\>6 hours from stroke onset, infarct core volume \\\u003C50 cc quantified by CTP\n\nExclusion Criteria:\n\n1. Females who are pregnant, or those of child-bearing potential with positive urine or serum beta Human Chorionic Gonadotropin (HCG) test\n2. Known severe allergy (more than a rash) to contrast media uncontrolled by medications.\n3. CT evidence of the following conditions:\n\n   * Midline shift or herniation\n   * Evidence of intracranial hemorrhage\n   * Mass effect with effacement of the ventricles\n4. Acute bilateral strokes\n5. Contraindication to antiplatelet (aspirin, clopidogrel, ticagrelor, cangrelor) or contrast agents\n6. 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\n7. 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\n8. Baseline platelet count \\\u003C80,000 per microliter (µl)\n9. Life expectancy less than one year prior to stroke onset\n10. Participation in another randomized clinical trial that could confound the evaluation of the study outcomes.\n11. 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\n12. New diagnosis of atrial fibrillation or a history of atrial fibrillation\n13. Suspected device-induced vasospasm defined as smooth transient narrowing of the target vessel\n14. Vessel dissection including any of the following: presence of dissection flap, false lumen, contrast stagnation in the vessel wall, and\u002For improving stenosis\n\n    \\-",[93,94],"ADULT","OLDER_ADULT",[96],{"facility":97,"status":7,"city":98,"state":99,"zip":100,"country":101,"contacts":102,"geoPoint":113},"ProMedica Toledo Hospital","Toledo","Ohio","43606","United States",[103,108,110],{"name":104,"role":105,"phone":106,"email":107},"Kathryn Scalzo","CONTACT","4192914068","Kathryn.Scalzo@ProMedica.org",{"name":109,"role":105},"Scalzo",{"name":111,"role":112},"Mouhammad Jumaa, MD","PRINCIPAL_INVESTIGATOR",{"lat":114,"lon":115},41.66394,-83.55521,[117,121],{"name":118,"role":105,"phone":119,"email":120},"Sami Al Kasab, MD","4192913498","alkasab@musc.edu",{"name":111,"role":105,"email":122},"Mouhammad.JumaaMD@ProMedica.org",[124,126,127],{"name":118,"affiliation":125,"role":112},"Medical University of South Carolina",{"name":111,"affiliation":97,"role":112},{"name":128,"affiliation":12,"role":129},"Tanya Siddiqui","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":133,"biomarkers":134},[20],[],{"nct_id":4,"found":14,"summary":136,"prompt_version":146},{"design":137,"status":138,"heading":139,"summary":140,"follow_up":141,"word_count":142,"commitments":143,"compensation":144,"drugs_mentioned":145},"This is an interventional study planning to enroll 342 participants. It compares two different procedures for treating stroke.","completed","Endovascular Rescue Therapy for Brain Stroke with Underlying Intracranial Stenosis","This study is looking at how safe and effective two different treatments are for people who have had a brain stroke (acute ischemic stroke). Both treatments involve mechanical thrombectomy, which is a procedure to remove a blood clot. One group will receive mechanical thrombectomy only. The other group will receive mechanical thrombectomy plus adjunct stenting, where a small tube (stent) is placed to keep the artery open. You might be able to join if you are between 18 and 80 years old, have symptoms of an acute ischemic stroke, and imaging shows a blockage in a main brain artery with significant narrowing (70-99% stenosis) remaining after an attempt to remove the clot. The study aims to see how well these treatments work and if they are safe, with results measured about 90 days after treatment. The current recruitment status is unclear.","Participants will be followed for safety and effectiveness for about 90 days after treatment.",141,"Not specified in the trial record.","Not stated in the trial record.",[34,42],"v2"]