[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06052969":3,"trial-entities:NCT06052969":84,"trial-summary:NCT06052969":88},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":38,"secondary_outcomes":43,"sex":47,"minimum_age":48,"maximum_age":49,"healthy_volunteers":50,"eligibility_criteria":51,"std_ages":55,"locations":58,"central_contacts":76,"overall_officials":81,"references":82,"see_also_links":83},"NCT06052969","MED-CLN-001P","Pulse Endovascular ReperFUSION for Acute Ischemic Stroke","PERFUSION AIS - Pulse Endovascular ReperFUSION for Acute Ischemic Stroke: An Early Feasibility Clinical Study","RECRUITING","2026-03-15","2025-08","2025-08-07","2023-10-01","Euphrates Vascular, Inc.","INDUSTRY",true,"Prospective, multi-center, single-arm early feasibility study enrolling a minimum of 15 subjects at up to a minimum of 3 active investigational sites in the United States.\n\nThe subjects must be diagnosed with acute ischemic stroke (AIS), must be post-mechanical thrombectomy, will have had intravenous thrombolytics, and have a visible MCA, ACA or PCA occlusive clot on initial angiographic imaging.\n\nEach subject will receive the Pulse NanoMED procedure after attempted neurovascular therapy to achieve better reperfusion.",null,[19,20],"Acute Ischemic Stroke AIS","Cerebral Arterial Disease",[22,23],"MicroBeads","Pulse NanoMed System","INTERVENTIONAL","TREATMENT",[27],"NA",{"count":29,"type":30},8,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36},"DEVICE","Pulse NanoMED System","The Pulse NanoMED System is comprised of iron nanoparticles and a small, portable, magnetic Workstation.",[37],"Group\u002FCohort",[39],{"measure":40,"description":41,"timeFrame":42},"Primary Objective","To test the safety and feasibility of the Pulse NanoMED System in ischemic stroke patients. The potential clinical benefit of early recanalization will be visually assessed by a core laboratory by comparing baseline DSA, CTA, or MRA images with images taken at set timepoints.","24 hours, 7 days (or discharge, if earlier), 30 days, and 90 days post-procedure",[44],{"measure":45,"description":46,"timeFrame":42},"Secondary Objective","To test the hypothesis that ischemic stroke patients that receive thrombolytic therapy and endovascular therapy will have improved reperfusion as assessed by eTICI and clinical outcomes when provided adjunctive treatment with the Pulse NanoMED System.","ALL","18 Years","85 Years",false,{"inclusion":52,"exclusion":53,"raw_text":54},[],[],"Inclusion Criteria:\n\n1. The participant provides written informed consent using an Informed Consent Form (ICF) that is reviewed and approved by the Institutional Review Board (IRB) or an acceptable patient surrogate.\n2. The participant is ≥ 18 years old and less than 85 years old.\n3. Patients with symptomatic large vessel occlusion (LVO) who undergo MT as part of their standard of care and have residual occlusion involving the anterior, middle or posterior cerebral arteries resulting in a eTICI score greater than 2b50 at the end of the procedure with three or less MT device passes.\n4. Estimated delay to onset of rescue Pulse NanoMED MicroBead administration \\\u003C9 hours from symptom onset, defined as the point in time the patient was last known well (LKW).\n5. Post-MT and has had thrombolytic therapy \\\u003C9 hours prior to the proposed start time of System therapy\n6. No significant pre-stroke functional disability (modified Rankin scale 0-1)\n7. Baseline NIHSS≥6\n8. ASPECTS \\>6 on non-contrast CT (NCCT) scan if symptoms lasting \\\u003C8 hours\n9. CT-Perfusion (CTP) is optional, if performed, should demonstrate rCBF \\\u003C30% lesion volume ≤70 mL.\n10. Imaging should be obtained within 75 minutes of the onset of mechanical thrombectomy.\n\nExclusion Criteria:\n\n1. NIHSS score on admission \\>25\n2. Use of carotid artery stents during the endovascular procedure requiring dual antiplatelet therapy\n3. Female who is pregnant or lactating or has a positive pregnancy test at the time of admission\n4. Current participation in another investigational drug or device treatment study\n5. Known allergy or sensitivity to iron\n6. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency\n7. Known coagulopathy, INR \\>1.7, or use of novel anticoagulants \\\u003C12h from symptom onset\n8. Known Platelets \\\u003C100,000\n9. Known Renal Failure as defined by a serum creatinine \\>3.0 mg\u002Fdl (or 265.2 μmol\u002Fl) or glomerular Filtration Rate \\[GFR\\] \\\u003C30\n10. Subject who requires hemodialysis or peritoneal dialysis or who has a contraindication to angiogram for whatever reason\n11. Any hemorrhage on CT\u002FMRI\n12. Clinical presentation suggests a subarachnoid hemorrhage, even if initial CT or MRI scan is normal.\n13. Suspicion of aortic dissection\n14. Subject currently uses or has a recent history of illicit drug(s) or abuses alcohol.\n15. History of life-threatening allergy (more than rash) to contrast medium\n16. SBP \\>185mmHg or DBP \\>110mmHg refractory to treatment\n17. Serious, advanced, terminal illness with anticipated life expectancy \\\u003C6 months\n18. Pre-existing neurological or psychiatric disease that would confound evaluation\n19. Presumed vasculitis or septic embolization\n20. Known sensitivity or allergy to contrast materials that cannot be previously treated properly\n21. The subject takes Coumadin and its interruption could compromise their safety\n22. Known allergy or contraindication to double antiplatelet treatment\n23. Known hypersensitivity or contraindication to iron or polyethylene glycol-based agents\n24. Known contraindication to MRI (examples include, but are not known, implantable cardioverter-defibrillator, pacemaker, clip-on or spiral aneurysm, neurostimulator)\n25. The physical geometry of the subject that prevents the placement of the magnet\n26. The subject has signs or symptoms of systemic infection\u002Fsepsis (temperature of ≥38.0 Celsius and\u002For white blood cell count of ≥12,000 cells\u002FuL). If the subject has a localized infection, such as cellulitis or osteomyelitis, or the infection is properly treated and controlled, according to the discretion of the researcher, the patient can enroll\n27. Known or suspected cardiovascular condition that causes a secondary or tertiary heart block, tachycardia-bradycardia syndrome, or symptomatic postural hypotension requiring medical intervention\n28. Known or suspected symptomatic hemochromatosis or hemosiderosis\n29. Known or suspected liver disease, such as hepatitis and\u002For cirrhosis\n30. The subject has received iron replacement therapy or contrast for iron-based MRI in the previous 30 days",[56,57],"ADULT","OLDER_ADULT",[59],{"facility":60,"status":8,"city":61,"state":62,"zip":63,"country":64,"contacts":65,"geoPoint":73},"University of South Carolina - Prisma","Columbia","South Carolina","29203","United States",[66,71],{"name":67,"role":68,"phone":69,"email":70},"Souvik Sen, MD, MS, MPH","CONTACT","803-545-6073","souvik.sen@uscmed.sc.edu",{"name":67,"role":72},"PRINCIPAL_INVESTIGATOR",{"lat":74,"lon":75},34.00071,-81.03481,[77],{"name":78,"role":68,"phone":79,"email":80},"Kristen Hlozek, PhD","857-334-0851","kristen@euphratesvascular.com",[],[],[],{"nct_id":4,"conditions":85,"biomarkers":87},[86],"Acute Ischemic Stroke",[],{"nct_id":4,"found":15,"summary":89,"prompt_version":99},{"design":90,"status":91,"heading":92,"summary":93,"follow_up":94,"word_count":95,"commitments":96,"compensation":97,"drugs_mentioned":98},"This is an early feasibility study, meaning it's one of the first steps to see if the treatment is safe and works. It's a single-arm study, which means all participants will receive the Pulse NanoMED procedure.","completed","Pulse NanoMED System for Acute Ischemic Stroke","This study is testing a new device called the Pulse NanoMED System for people who have had an acute ischemic stroke (a stroke caused by a blood clot). You might be able to join if you are between 18 and 85 years old, have had a mechanical thrombectomy (a procedure to remove a blood clot), received clot-busting medication (intravenous thrombolytics), and still have a visible clot in certain brain arteries. The study aims to see if the Pulse NanoMED procedure, used after other treatments, can improve blood flow to the brain. Researchers will check your progress at 24 hours, 7 days (or when you leave the hospital), 30 days, and 90 days after the procedure. The current status of this study is unclear, and it plans to enroll at least 15 participants.","Participants will be followed for 90 days after the procedure to assess their progress.",132,"You would receive the Pulse NanoMED procedure after other stroke treatments. Your health will be checked at 24 hours, 7 days (or discharge), 30 days, and 90 days after the procedure.","Not stated in the trial record.",[34],"v2"]