- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06029491
The Pivotal Study of RapidPulseTM Aspiration System (PIVOTAL)
September 1, 2023 updated by: RapidPulse, Inc
The Pivotal Study of RapidPulseTM Aspiration System as Frontline Approach for Patient With Acute Ischemic Stroke Due to Large Vessel Occlusions
The goal of this clinical trials is to demonstrate the safety and effectiveness for the RapidPulseTM Aspiration System in patients experiencing acute ischemic stroke within 8 hours of symptom onset or last seen normal.
Subjects will undergo mechanical thrombectomy (a procedure to remove a clot in the brain which is preventing blood flow), with the RapidPulseTM Aspiration System.
Participation in the trial is for 90 days.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
The purpose of this prospective, open label clinical trials is to demonstrate the safety and effectiveness for the RapidPulseTM Aspiration System as frontline approach in the treatment of large vessel occlusions in patients experiencing Acute Ischemic Stroke within 8 hours of symptom onset or last seen normal.
The target sample size for this clinical trial is 170 subjects enrolled in up to 30 sites globally.
The maximum number of subjects that may be enrolled is 340.
Subjects will undergo mechanical thrombectomy procedure and will have postoperative assessments completed at 24 hours and on day 5-7 or hospital discharge (whichever comes first).
The final study visit will occur approximately 90 days after the index event.
The primary effectiveness endpoint is the proportion of patients who achieve First Pass Reperfusion Effect (FPE) as defined by modified treatment in cerebral infarction score (mTICI) ≥ 2c after the first pass as assessed by an independent Imaging Core Lab.
The primary safety endpoint is the proportion of patients with symptomatic ICH (sICH) at 24 hours post-thrombectomy as assessed by a central events committee (CEC).
Study Type
Interventional
Enrollment (Estimated)
170
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Cynthia Yang
- Phone Number: 9498367402
- Email: cyang@rapidpulsemed.com
Study Locations
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Istanbul, Turkey, 34295
- Istanbul Aydan University VM MedicalPark Florya
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Contact:
- Ata Aydincan
- Phone Number: 0090 532 413 20 86
- Email: aaydincan@croturk.com
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Principal Investigator:
- Serdar Geyik, MD
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age 18 to 80 years
- Clinical diagnosis of acute ischemic stroke with NIH Stroke Scale (NIHSS) score ≥ 6
- Able to be treated within 8 hours of symptom onset or last known normal (LKN)
- Able to be treated within 120 minutes from the time of the qualifying baseline CT/MR image
- Pre-morbid Modified Rankin Scale (mRS) score 0-1
- Angiographic confirmation of large vessel occlusion (LVO) in the anterior (intracranial ICA or MCA M1 or M2 segments) or posterior circulation (vertebral or basilar arteries) as confirmed by digital subtraction angiography (DSA) irrespective of IV thrombolysis administration
- Candidate to receive treatment with ADAPT technique (Direct Aspiration First-Pass Technique)
Exclusion Criteria:
- Intracranial Hemorrhage (ICH)
- Alberta Stroke Program Early CT Score (ASPECTS) <6
- Intracranial Atherosclerotic Disease (ICAD)
- Multiple or tandem occlusions
- Life expectancy less than 90 days
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment Arm
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 the thrombus in the neuro-vasculature using the RapidPulseTM Aspiration System.
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The RapidPulseTM Aspiration System is designed to remove occlusive thrombus from the occluded cerebral vasculature using precisely pulsed aspiration.
The system is comprised of the multi-use, non-sterile RapidPulse TM Aspiration Pump, the single use, sterile RapidPulseTM Tube set, the single use, non-sterile RapidPulseTM Collection Canister and the single use, sterile RapidPulseTM 071 Catheter.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary Effectiveness Endpoint
Time Frame: Intra-procedural
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The proportion of patients who achieve First Pass Reperfusion Effect (FPE) as defined by mTICI ≥ 2c after the first pass as assessed by an independent Imaging Core Lab.
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Intra-procedural
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Primary Safety Endpoint
Time Frame: Post-procedural (24 hours post-thrombectomy)
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The proportion of patients with symptomatic ICH (sICH) at 24 hours post-thrombectomy as assessed by CEC.
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Post-procedural (24 hours post-thrombectomy)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Key Secondary Endpoint #1
Time Frame: Intra-procedural
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Proportion of patients who achieve mTICI ≥ 2b, based on the best mTICI score within a maximum of 3 passes where only aspiration with Study Device was used without rescue, as assessed by an independent Imaging Core Lab.
The performance goal is 0.55.
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Intra-procedural
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Key Secondary Endpoint #2
Time Frame: Intra-procedural
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The proportion of patients achieving FPE reperfusion as defined by mTICI ≥ 2c after one reperfusion attempt as assessed by independent Imaging Core Lab.
The performance goal is 0.4547.
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Intra-procedural
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Key Secondary Endpoint #3
Time Frame: Post-procedure (90 days post-thrombectomy)
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Proportion of patients who achieve mRS ≤2 at 90-days post treatment.
The performance goal is 0.4578.
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Post-procedure (90 days post-thrombectomy)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Technical Endpoint #1
Time Frame: Intra-procedural
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Modified First Pass Reperfusion Effect (mFPE) as defined by mTICI ≥ 2b after one device pass as assessed by an independent Imaging Core lab.
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Intra-procedural
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Technical Endpoint #2
Time Frame: Intra-procedural
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Final mTICI ≥ 2b after all passes (including any rescue therapy) at procedure conclusion as assessed by independent Imaging Core Lab.
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Intra-procedural
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Technical Endpoint #3
Time Frame: Intra-procedural
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Time from arterial puncture (procedure initiation) to achieve mTICI ≥ 2b using first line aspiration treatment.
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Intra-procedural
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Clinical Endpoint #1
Time Frame: Post-procedure (24 hours post-thrombectomy)
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Proportion of patients with major early neurological recovery at 24-hours as defined by reduction in NIHSS score from baseline of at least 8 points or reaching NIHSS 0-1.
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Post-procedure (24 hours post-thrombectomy)
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Clinical Endpoint #2
Time Frame: Pre-procedure to post-procedure (index event assessment to 24 hours post-thrombectomy)
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Change in NIHSS score from Baseline to 24-hours.
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Pre-procedure to post-procedure (index event assessment to 24 hours post-thrombectomy)
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Safety Endpoint #1
Time Frame: Intra-procedural to post-procedure (through 90 days post-thrombectomy)
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All device-related and procedure-related serious adverse events as assessed by an independent CEC.
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Intra-procedural to post-procedure (through 90 days post-thrombectomy)
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Safety Endpoint #2
Time Frame: Intra-procedural to post-procedure (through 90 days post-thrombectomy)
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All-cause mortality assessed through 90 days post index procedure.
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Intra-procedural to post-procedure (through 90 days post-thrombectomy)
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Safety Endpoint #3
Time Frame: Intra-procedural
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Device-related vasospasm as assessed by an independent CEC.
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Intra-procedural
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Safety Endpoint #4
Time Frame: Intra-procedural
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Embolism in new territory determined based on procedural angiogram as assessed by an independent Imaging Core Lab.
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Intra-procedural
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Safety Endpoint #5
Time Frame: Post-procedural (24 hours post-thrombectomy)
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Any intracranial hemorrhage according to the Heidelberg classification at 24-hours as assessed by an independent Imaging Core Lab.
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Post-procedural (24 hours post-thrombectomy)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Raul G Nogueira, MD, University of Pittsburgh Medical Center Stroke Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
October 1, 2023
Primary Completion (Estimated)
August 1, 2024
Study Completion (Estimated)
November 1, 2024
Study Registration Dates
First Submitted
September 1, 2023
First Submitted That Met QC Criteria
September 1, 2023
First Posted (Actual)
September 8, 2023
Study Record Updates
Last Update Posted (Actual)
September 8, 2023
Last Update Submitted That Met QC Criteria
September 1, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CIP-0002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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