Back to resultsFeasibility Study of RapidPulseTM Aspiration System as Frontline Approach for Patients With Acute Ischemic Stroke (PULSE-F)
Primary Purpose
Acute Ischemic Stroke
Status
Recruiting
Phase
Not Applicable
Locations
Georgia
Study Type
Interventional
Intervention
RapidPulseTM Aspiration System
Sponsored by
About this trial
This is an interventional device feasibility trial for Acute Ischemic Stroke focused on measuring Stroke, Large Vessel Occlusion, Mechanical Thrombectomy, Neurovascular Intervention
Eligibility Criteria
Inclusion Criteria:
- Age 18 years or older
- Clinical diagnosis of acute ischemic stroke with symptom onset (or last seen normal) within 24 hours
- Large vessel occlusion (LVO) involving the intracranial internal carotid artery (ICA), middle cerebral artery (MCA) M1 or M2 segments, basilar or vertebral artery
- Target occlusion can be accessed by the Medtronic React 71 aspiration catheter
Exclusion Criteria:
- Known or suspected intracranial atherosclerotic disease (ICAD)
- Tandem occlusions
Sites / Locations
- National Institute of SurgeryRecruiting
- Pineo Medical EcosystemsRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment Arm
Arm Description
Each subject will undergo baseline evaluation for acute ischemic stroke due to large vessel occlusion, per standard of care and undergo mechanical thrombectomy procedure, aspiration to remove thrombus in the neuro-vasculature using the RapidPulseTM (feasibility) device.
Outcomes
Primary Outcome Measures
First Pass Reperfusion Effect (FPE)
Defined by mTICI greater than or equal to 2c after one reperfusion attempt
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05577351
Brief Title
Feasibility Study of RapidPulseTM Aspiration System as Frontline Approach for Patients With Acute Ischemic Stroke
Acronym
PULSE-F
Official Title
PULSE-F: Feasibility Study of RapidPulseTM Aspiration System as Frontline Approach for Patients With Acute Ischemic Stroke Due to Large Vessel Occlusions
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 23, 2023 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RapidPulse, Inc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A feasibility study to evaluate the initial safety and performance of the RapidPulseTM Aspiration System in the treatment of patients with Acute Ischemic Stroke (AIS) due to Large Vessel Occlusion (LVO) in the intracranial ICA, M1, M2, basilar or vertebral arteries.
Detailed Description
The purpose of this prospective, open label clinical trial is to assess the initial safety and performance of the RapidPulseTM Aspiration System as frontline approach for patients with acute ischemic stroke due to large vessel occlusions identified within 24 hours of symptom onset (or last seen normal). The study will enroll up to a maximum of 50 subjects in 2 centers in Georgia. Subjects will undergo mechanical thrombectomy procedure and will have post-operative assessments completed at 24 hours and on Day 5-7 or upon hospital discharge.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke
Keywords
Stroke, Large Vessel Occlusion, Mechanical Thrombectomy, Neurovascular Intervention
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective, multi-center, open-label, single-arm study to assess the initial technical effectiveness and safety of the RapidPulseTM (feasibility version). As such, no formal statistical hypothesis will be tested in this study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
Each subject will undergo baseline evaluation for acute ischemic stroke due to large vessel occlusion, per standard of care and undergo mechanical thrombectomy procedure, aspiration to remove thrombus in the neuro-vasculature using the RapidPulseTM (feasibility) device.
Intervention Type
Device
Intervention Name(s)
RapidPulseTM Aspiration System
Other Intervention Name(s)
Aspiration Thrombectomy
Intervention Description
The RapidPulseTM Aspiration System paired with a single-use, disposable tubing set specific for use with the RapidPulseTM Aspiration System
Primary Outcome Measure Information:
Title
First Pass Reperfusion Effect (FPE)
Description
Defined by mTICI greater than or equal to 2c after one reperfusion attempt
Time Frame
Intra-procedural
Other Pre-specified Outcome Measures:
Title
Frontline Technical Success
Description
As defined by mTICI 2b or greater after the last pass with Study Device (no rescue therapy)
Time Frame
Intra-procedural
Title
Final mTICI
Description
After all passes (including any rescue therapy)
Time Frame
Intra-procedural
Title
Modified First Pass Reperfusion Effect (mFPE)
Description
Defined as mTICI 2b or greater after one device pass
Time Frame
Intra-procedural
Title
Device-related and procedure-related adverse events
Description
Including vessel injury, distal emboli, emboli in new territory (ENT) and vessel spasm
Time Frame
Intra and post-procedural (up to 24 hours)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 years or older
Clinical diagnosis of acute ischemic stroke with symptom onset (or last seen normal) within 24 hours
Large vessel occlusion (LVO) involving the intracranial internal carotid artery (ICA), middle cerebral artery (MCA) M1 or M2 segments, basilar or vertebral artery
Target occlusion can be accessed by the Medtronic React 71 aspiration catheter
Exclusion Criteria:
Known or suspected intracranial atherosclerotic disease (ICAD)
Tandem occlusions
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cynthia Yang
Phone
9498367402
Email
cyang@rapidpulsemed.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raul G Nogueira, MD
Organizational Affiliation
University of Pittsburgh Medical Center Stroke Institute
Official's Role
Study Chair
Facility Information:
Facility Name
National Institute of Surgery
City
Tbilisi
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giorgi Egutidze, MD
Email
eguta1985@gmail.com
Facility Name
Pineo Medical Ecosystems
City
Tbilisi
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Tsiskaridze, MD
Email
alexander.tsiskaridze@tsu.ge
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Feasibility Study of RapidPulseTM Aspiration System as Frontline Approach for Patients With Acute Ischemic Stroke
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