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Pulse Endovascular ReperFUSION for Acute Ischemic Stroke (PERFUSION AIS)

Primary Purpose

Acute Ischemic Stroke AIS, Cerebral Arterial Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pulse NanoMED System
Sponsored by
Euphrates Vascular, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke AIS focused on measuring MicroBeads, Pulse NanoMed System

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion 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 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). 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. Exclusion Criteria: 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 osteomyelitis, or the infection is properly treated and controlled, according to the discretion of the researcher, the patient can enroll 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

Sites / Locations

  • University of South Carolina - PrismaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Group/Cohort

Arm Description

Subjects presenting to the emergency department with AIS, eligible for thrombolytic therapy, and with evidence of an occlusive clot by angiographic imaging will be considered for inclusion in the study. Post-thrombolytic therapy and mechanical thrombectomy eligible Subjects will receive the experimental NanoMED device.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 11, 2023
Last Updated
October 2, 2023
Sponsor
Euphrates Vascular, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT06052969
Brief Title
Pulse Endovascular ReperFUSION for Acute Ischemic Stroke
Acronym
PERFUSION AIS
Official Title
PERFUSION AIS - Pulse Endovascular ReperFUSION for Acute Ischemic Stroke: An Early Feasibility Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
March 15, 2024 (Anticipated)
Study Completion Date
March 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Euphrates Vascular, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke AIS, Cerebral Arterial Disease
Keywords
MicroBeads, Pulse NanoMed System

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective, multi-center, single-arm early feasibility study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group/Cohort
Arm Type
Experimental
Arm Description
Subjects presenting to the emergency department with AIS, eligible for thrombolytic therapy, and with evidence of an occlusive clot by angiographic imaging will be considered for inclusion in the study. Post-thrombolytic therapy and mechanical thrombectomy eligible Subjects will receive the experimental NanoMED device.
Intervention Type
Device
Intervention Name(s)
Pulse NanoMED System
Intervention Description
The Pulse NanoMED System is comprised of iron nanoparticles and a small, portable, magnetic Workstation.
Primary Outcome Measure Information:
Title
Primary Objective
Description
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-procedure
Secondary Outcome Measure Information:
Title
Secondary Objective
Description
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-procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion 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 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). 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. Exclusion Criteria: 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 osteomyelitis, or the infection is properly treated and controlled, according to the discretion of the researcher, the patient can enroll 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kristen Hlozek, PhD
Phone
857-334-0851
Email
kristen@euphratesvascular.com
Facility Information:
Facility Name
University of South Carolina - Prisma
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Souvik Sen, MD, MS, MPH
Phone
803-545-6073
Email
souvik.sen@uscmed.sc.edu
First Name & Middle Initial & Last Name & Degree
Souvik Sen, MD, MS, MPH

12. IPD Sharing Statement

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Pulse Endovascular ReperFUSION for Acute Ischemic Stroke

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