Back to resultsFeasibility Study of RapidPulseTM Aspiration System as Frontline Approach for Stroke Patients (RapidPulseFS)
Primary Purpose
Acute Ischemic Stroke
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
RapidPulseTM Aspiration System
Standard of Care Aspiration Thrombectomy System
Sponsored by
About this trial
This is an interventional treatment trial for Acute Ischemic Stroke focused on measuring Large vessel occlusion, Mechanical thrombectomy, Neurovascular intervention
Eligibility Criteria
Key Inclusion Criteria:
- Age 18 years or older
- Clinical diagnosis of acute ischemic stroke with NIH Stroke Scale (NIHSS) score ≥ 6 with symptom onset (or last seen normal) up to 24 hours
- Large vessel occlusion in the intracranial internal carotid artery (ICA), middle cerebral artery (MCA) M1 or M2 segments, basilar or vertebral artery
Key Exclusion Criteria:
- Evidence of hemorrhage
- Significant mass effect and/or midline shift
- Vessel tortuosity too difficult to allow endovascular access per investigator judgment
- Severe or fatal co-morbidities
Sites / Locations
- General Hospital of Fortaleza
- Odense University Hospital
- Pauls Stradiņš Clinical University Hospital
- Hospital General Universitari d'Alicante
- Istanbul Aydin University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Treatment Arm
Control Arm
Arm Description
RapidPulseTM Aspiration System with commercially available Medtronic React 71 aspiration catheter and commercially available aspiration pump as frontline approach thrombectomy technique.
Treatment with commercially available aspiration catheter with commercially available aspiration pump as frontline approach thrombectomy technique.
Outcomes
Primary Outcome Measures
First Pass Reperfusion Effect (FPE)
Defined by modified Thrombolysis In Cerebral Infarction scale (mTICI 2c-3) flow in the target vessel
Secondary Outcome Measures
Frontline technical success
Defined by mTICI ≥ 2b after the last pass with Study Device with no rescue therapy
Good functional outcome measured by Modified Rankin Scale score of 0 - 2 at 90 days post index procedure
The Modified Rankin Scale (mRS) measures neurological disability or dependence for stroke patients on a scale of 0 (no symptoms) to 6 (deceased)
Rate of Symptomatic intracranial hemorrhage (sICH) at 24 hours post-procedure
All cause mortality rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05122637
Brief Title
Feasibility Study of RapidPulseTM Aspiration System as Frontline Approach for Stroke Patients
Acronym
RapidPulseFS
Official Title
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
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 31, 2022 (Actual)
Primary Completion Date
September 23, 2022 (Actual)
Study Completion Date
December 20, 2022 (Actual)
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
Yes
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).
Detailed Description
The purpose of this study is to evaluate the initial safety and performance of the RapidPulse Inc. RapidPulseTM Aspiration System as frontline approach for use in the treatment of patients with Acute Ischemic Stroke (AIS) due to Large Vessel Occlusion (LVO). This is a prospective, multi-center, open label study comparing the safety and performance of the RapidPulseTM Aspiration System with non-randomized retrospective controls who otherwise meet the same study inclusion/exclusion criteria. The study will enroll a maximum of 100 participants in the Treatment Arm and a maximum of 200 participants in the Control Arm at in up to 10 centers in Europe and/or Latin America. Subjects data will be collected through hospitalization with a 3 months post-procedure study visit.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke
Keywords
Large vessel occlusion, Mechanical thrombectomy, Neurovascular intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
RapidPulseTM Aspiration System with commercially available Medtronic React 71 aspiration catheter and commercially available aspiration pump as frontline approach thrombectomy technique.
Arm Title
Control Arm
Arm Type
Other
Arm Description
Treatment with commercially available aspiration catheter with commercially available aspiration pump as frontline approach thrombectomy technique.
Intervention Type
Device
Intervention Name(s)
RapidPulseTM Aspiration System
Intervention Description
The RapidPulseTM Aspiration System with Medtronic React 71 aspiration catheter and a commercially available pump.
Intervention Type
Device
Intervention Name(s)
Standard of Care Aspiration Thrombectomy System
Intervention Description
Commercially available aspiration catheter with commercially available aspiration pump
Primary Outcome Measure Information:
Title
First Pass Reperfusion Effect (FPE)
Description
Defined by modified Thrombolysis In Cerebral Infarction scale (mTICI 2c-3) flow in the target vessel
Time Frame
Intra-procedural
Secondary Outcome Measure Information:
Title
Frontline technical success
Description
Defined by mTICI ≥ 2b after the last pass with Study Device with no rescue therapy
Time Frame
Intra-procedural
Title
Good functional outcome measured by Modified Rankin Scale score of 0 - 2 at 90 days post index procedure
Description
The Modified Rankin Scale (mRS) measures neurological disability or dependence for stroke patients on a scale of 0 (no symptoms) to 6 (deceased)
Time Frame
90 days
Title
Rate of Symptomatic intracranial hemorrhage (sICH) at 24 hours post-procedure
Time Frame
24 hours
Title
All cause mortality rate
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Age 18 years or older
Clinical diagnosis of acute ischemic stroke with NIH Stroke Scale (NIHSS) score ≥ 6 with symptom onset (or last seen normal) up to 24 hours
Large vessel occlusion in the intracranial internal carotid artery (ICA), middle cerebral artery (MCA) M1 or M2 segments, basilar or vertebral artery
Key Exclusion Criteria:
Evidence of hemorrhage
Significant mass effect and/or midline shift
Vessel tortuosity too difficult to allow endovascular access per investigator judgment
Severe or fatal co-morbidities
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
General Hospital of Fortaleza
City
Fortaleza
Country
Brazil
Facility Name
Odense University Hospital
City
Odense
Country
Denmark
Facility Name
Pauls Stradiņš Clinical University Hospital
City
Riga
Country
Latvia
Facility Name
Hospital General Universitari d'Alicante
City
Alicante
Country
Spain
Facility Name
Istanbul Aydin University
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Feasibility Study of RapidPulseTM Aspiration System as Frontline Approach for Stroke Patients
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