Acute Ischemic StrokeRapidPulseFSNCT05122637
Feasibility Study of RapidPulseTM Aspiration System as Frontline Approach for Stroke Patients
A study testing RapidPulseTM Aspiration System in people with Acute Ischemic Stroke, run by RapidPulse, Inc at 5 sites in 5 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- RapidPulseTM Aspiration System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 5 sitesin 5 countries
- Study dates
- 31 Jan 2022to 20 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
About this study
Official title: Feasibility Study of RapidPulseTM Aspiration System as Frontline Approach for Patients With Acute Ischemic Stroke Due to Large Vessel Occlusions
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).
Read the 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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- RapidPulseTM Aspiration System, Standard of Care Aspiration Thrombectomy System
- Keywords
- Large vessel occlusion, Mechanical thrombectomy, Neurovascular intervention
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RapidPulseTM Aspiration SystemDevice
The RapidPulseTM Aspiration System with Medtronic React 71 aspiration catheter and a commercially available pump.
Standard of Care Aspiration Thrombectomy SystemDevice
Commercially available aspiration catheter with commercially available aspiration pump
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | RapidPulseTM Aspiration System with commercially available Medtronic React 71 aspiration catheter and commercially available aspiration pump as frontline approach thrombectomy technique. Receives: Device: RapidPulseTM Aspiration System |
| Control Arm | Other | Treatment with commercially available aspiration catheter with commercially available aspiration pump as frontline approach thrombectomy technique. Receives: Device: Standard of Care Aspiration Thrombectomy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
First Pass Reperfusion Effect (FPE)
Defined by modified Thrombolysis In Cerebral Infarction scale (mTICI 2c-3) flow in the target vessel
Measured: Intra-procedural
Secondary outcomes (4)
Frontline technical success
Defined by mTICI ≥ 2b after the last pass with Study Device with no rescue therapy
Measured: Intra-procedural
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)
Measured: 90 days
Rate of Symptomatic intracranial hemorrhage (sICH) at 24 hours post-procedure
Measured: 24 hours
All cause mortality rate
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start31 Jan 2022
- Primary completion23 Sep 2022
- Study completion20 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- RapidPulse, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Raul G Nogueira, MD, Study chair, University of Pittsburgh Medical Center Stroke Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05122637
- Sponsor's protocol ID
- DEV-0213
- Acronym
- RapidPulseFS
- Status last verified
- Feb 2023
- First submitted
- 3 Nov 2021
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of RapidPulseTM Aspiration System as Frontline Approach for Patients With Acute Ischemic Stroke Due to Large Vessel Occlusions
- ClinicalTrials.gov ID
- NCT05122637
- Acronym / sponsor ID
- RapidPulseFS / DEV-0213
- Conditions
- Acute Ischemic Stroke
- Keywords
- Large vessel occlusion, Mechanical thrombectomy, Neurovascular intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- RapidPulse, IncIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2022 (actual)
- Primary completion
- 23 Sep 2022 (actual)
- Study completion
- 20 Dec 2022 (actual)
- First posted
- 17 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Device: RapidPulseTM Aspiration SystemRapidPulseTM Aspiration System with commercially available Medtronic React 71 aspiration catheter and commercially available aspiration pump as frontline approach thrombectomy technique. |
| Control Arm | Other | Device: Standard of Care Aspiration Thrombectomy SystemTreatment with commercially available aspiration catheter with commercially available aspiration pump as frontline approach thrombectomy technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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 (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RapidPulseTM Aspiration SystemThe RapidPulseTM Aspiration System with Medtronic React 71 aspiration catheter and a commercially available pump. | Device | Treatment Arm |
| Standard of Care Aspiration Thrombectomy SystemCommercially available aspiration catheter with commercially available aspiration pump | Device | Control Arm |
Primary outcome
First Pass Reperfusion Effect (FPE)
Time frame: Intra-procedural
Defined by modified Thrombolysis In Cerebral Infarction scale (mTICI 2c-3) flow in the target vessel
4 secondary outcomes
Frontline technical success
Time frame: Intra-procedural
Good functional outcome measured by Modified Rankin Scale score of 0 - 2 at 90 days post index procedure
Time frame: 90 days
Rate of Symptomatic intracranial hemorrhage (sICH) at 24 hours post-procedure
Time frame: 24 hours
All cause mortality rate
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raul G Nogueira, MD study chair
University of Pittsburgh Medical Center Stroke Institute
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RapidPulseTM Aspiration System in people with Acute Ischemic Stroke, run by RapidPulse, Inc at 5 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Brazil, Denmark, Latvia, Spain, Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First Pass Reperfusion Effect (FPE) (time frame: Intra-procedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2023.