Pulse Endovascular ReperFUSION for Acute Ischemic Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorEuphrates Vascular, Inc.
About this trial
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.
Each subject will receive the Pulse NanoMED procedure after attempted neurovascular therapy to achieve better reperfusion.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 score greater than 2b50 at the end of the procedure with three or less MT device passes.
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).
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Pulse NanoMED System
DeviceThe Pulse NanoMED System is comprised of iron nanoparticles and a small, portable, magnetic Workstation.
Treatment groups
8 Participants
are divided into 1 treatment groupGroup A: Group/CohortExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
24 hours, 7 days (or discharge, if earlier), 30 days, and 90 days post-procedureSecondary outcomes
1
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.
Time frame
24 hours, 7 days (or discharge, if earlier), 30 days, and 90 days post-procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov