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New treatment option for Acute Ischemic Stroke AIS
Official title Pulse Endovascular ReperFUSION for Acute Ischemic Stroke
ClinicalTrials.gov ID: NCT06052969
What this study is testing
- What it's testing
- 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. The 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- The participant provides written informed consent using an Informed Consent Form (ICF) that is reviewed and approved by the Institutional Review...
- The participant is ≥ 18 years old and less than 85 years old.
- Patients with symptomatic large vessel occlusion (LVO) who undergo MT as part of their standard of care and have residual occlusion involving the...
- Estimated delay to onset of rescue Pulse NanoMED MicroBead administration \<9 hours from symptom onset, defined as the point in time the patient was...
- Post-MT and has had thrombolytic therapy \<9 hours prior to the proposed start time of System therapy
You likely can't join if
- NIHSS score on admission \>25
- Use of carotid artery stents during the endovascular procedure requiring dual antiplatelet therapy
- Female who is pregnant or lactating or has a positive pregnancy test at the time of admission
- Current participation in another investigational drug or device treatment study
- Known allergy or sensitivity to iron
- Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency
See the full eligibility criteria
- 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.
- The participant is ≥ 18 years old and less than 85 years old.
- 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...
- Estimated delay to onset of rescue Pulse NanoMED MicroBead administration \<9 hours from symptom onset, defined as the point in time the patient was last known well (LKW).
- Post-MT and has had thrombolytic therapy \<9 hours prior to the proposed start time of System therapy
- No significant pre-stroke functional disability (modified Rankin scale 0-1)
- Baseline NIHSS≥6
- ASPECTS \>6 on non-contrast CT (NCCT) scan if symptoms lasting \<8 hours
- CT-Perfusion (CTP) is optional, if performed, should demonstrate rCBF \<30% lesion volume ≤70 mL.
- Imaging should be obtained within 75 minutes of the onset of mechanical thrombectomy.
- NIHSS score on admission \>25
- Use of carotid artery stents during the endovascular procedure requiring dual antiplatelet therapy
- Female who is pregnant or lactating or has a positive pregnancy test at the time of admission
- Current participation in another investigational drug or device treatment study
- Known allergy or sensitivity to iron
- Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency
- Known coagulopathy, INR \>1.7, or use of novel anticoagulants \<12h from symptom onset
- Known Platelets \<100,000
- Known Renal Failure as defined by a serum creatinine \>3.0 mg/dl (or 265.2 μmol/l) or glomerular Filtration Rate [GFR] \<30
- Subject who requires hemodialysis or peritoneal dialysis or who has a contraindication to angiogram for whatever reason
- Any hemorrhage on CT/MRI
- Clinical presentation suggests a subarachnoid hemorrhage, even if initial CT or MRI scan is normal.
- Suspicion of aortic dissection
- Subject currently uses or has a recent history of illicit drug(s) or abuses alcohol.
- History of life-threatening allergy (more than rash) to contrast medium
- SBP \>185mmHg or DBP \>110mmHg refractory to treatment
- Serious, advanced, terminal illness with anticipated life expectancy \<6 months
- Pre-existing neurological or psychiatric disease that would confound evaluation
- Presumed vasculitis or septic embolization
- Known sensitivity or allergy to contrast materials that cannot be previously treated properly
- The subject takes Coumadin and its interruption could compromise their safety
- Known allergy or contraindication to double antiplatelet treatment
- Known hypersensitivity or contraindication to iron or polyethylene glycol-based agents
- Known contraindication to MRI (examples include, but are not known, implantable cardioverter-defibrillator, pacemaker, clip-on or spiral aneurysm, neurostimulator)
- The physical geometry of the subject that prevents the placement of the magnet
- The subject has signs or symptoms of systemic infection/sepsis (temperature of ≥38.0 Celsius and/or white blood cell count of ≥12,000 cells/uL). If the subject has a localized infection, such as cellulitis or...
- Known or suspected cardiovascular condition that causes a secondary or tertiary heart block, tachycardia-bradycardia syndrome, or symptomatic postural hypotension requiring medical intervention
- Known or suspected symptomatic hemochromatosis or hemosiderosis
- Known or suspected liver disease, such as hepatitis and/or cirrhosis
- The subject has received iron replacement therapy or contrast for iron-based MRI in the previous 30 days
The study team makes the final eligibility decision.
Where it's taking place
- Columbia, South Carolina, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Columbia, South Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.