Acute Ischemic StrokeSUMMITNZNCT05429658
Single Arm Trial to Evaluate the Safety and Effectiveness of the Route 92 Medical Reperfusion System
A study testing Thrombectomy in people with Acute Ischemic Stroke, run by Route 92 Medical, Inc. at 2 sites in New Zealand.
Trial summary
The objective of the study is to evaluate the safety and effectiveness of the Route 92 Medical Monopoint Reperfusion System with the Hi Point 88 and HiPoint 70 Reperfusion Catheters when used to aspirate emboli in acute ischemic stroke patients. 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?
- Thrombectomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 2 sitesNew Zealand
- Study dates
- 27 Sep 2019to 24 Feb 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
- The consent process has been completed with the subject, Legally Authorized Representative, or two physician best interest and consent is documented
- Age >18 years
- Clinical signs consistent with an acute ischemic stroke
- Baseline National Institutes of Health Stroke Scale (NIHSS) score >= 6
- Pre-stroke modified Rankin Score (mRS) <= 2
- Acute occlusion of the M1 segment of the middle cerebral artery (MCA), internal carotid artery (ICA), vertebral or basilar arteries confirmed via computed tomography angiography (CTA) and/or magnetic resonance angiography (MRA)
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- The Investigator estimates that at least one delivery of the Route 92 Medical Reperfusion System can be completed within 24 hours of time last known well
- In the opinion of the Investigator, reperfusion of the ischemic territory will result in clinical benefit
- Angiographic confirmation of an occlusion of the M1 segment* of the middle cerebral artery, internal carotid artery, vertebral or basilar arteries with a modified Thrombolysis In Cerebral Infarction (mTICI) scale score of 0-1
Who cannot join
- Known pregnancy or breast feeding
- Known comorbidity that may complicate treatment or prevent improvement or follow-up
- Known life expectancy < 12 months
- Known history of severe allergy to contrast medium
- Subject known to have suffered a stroke in the past 90 days
- Subject participating in another study involving an investigational device or drug.
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- Known connective tissue disorder affecting the arteries (e.g. Marfan syndrome, fibromuscular dysplasia, Ehlers-Danlos syndrome)
- Any known pre-existing hemorrhagic or coagulation deficiency
- Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of recent/ fresh hemorrhage
- Baseline CT or MRI showing intracranial tumor (except small meningioma)
- Angiographic evidence of dissection in the extracranial or intracranial arteries
- Angiographic evidence of carotid dissection
- Angiographic evidence of multiple vascular occlusions (e.g., bilateral anterior circulation, anterior/posterior circulation). Note: tandem occlusions may be included at the discretion of the operating physician.
Trial locations and contacts
2 sites in 1 country.
New Zealand2 sites
Auckland City Hospital
Auckland, 1023
Christchurch Hospital
Christchurch, 8011
About this study
Official title: A Prospective, Single-arm, Interventional Clinical Trial to Evaluate the Safety and Effectiveness of the Route 92 Medical MonoPoint Reperfusion System for Aspiration Embolectomy in Acute Ischemic Stroke Patients
The objective of the study is to evaluate the safety and effectiveness of the Route 92 Medical Monopoint Reperfusion System with the Hi Point 88 and HiPoint 70 Reperfusion Catheters when used to aspirate emboli in acute ischemic stroke patients.
Read the detailed description
The objective of the study is to evaluate the safety and effectiveness of the Route 92 Medical Monopoint Reperfusion System with the Hi Point 88 and HiPoint 70 Reperfusion Catheters when used to aspirate emboli in acute ischemic stroke patients.
The study design is an interventional, prospective, single-arm, open label clinical trial.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Thrombectomy
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThrombectomyDevice
The Route 92 Medical Reperfusion System is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease within the internal carotid, middle cerebral, basilar and vertebral arteries.
| Study group | Role | What they receive |
|---|---|---|
| Thrombectomy | Experimental | Aspiration of clot with large bore catheter in acute ischemic stroke patients Receives: Device: Thrombectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness
The primary effectiveness endpoint is arterial revascularization as measured by a modified Thrombolysis in Cerebrovascular Infarction (mTICI) score of 2b or greater at the end of angiography after all endovascular treatments.
Measured: Procedure
Device-related peri-procedural complications
dissection or perforation
Measured: Procedure
Symptomatic Intracranial Cerebral Hemorrhage (SICH)
defined as type 2 parenchymal hemorrhage with a deterioration in National Institutes of Health Stroke Scale [NIHSS] score of >=4 points
Measured: 24 hour
Embolization to a previously uninvolved territory
Embolization to a previously uninvolved territory
Measured: Procedure
Secondary outcomes (4)
NIHSS score
The National Institutes of Health Stroke Scale (NIHSS) is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke
Measured: 24 hours after treatment
Modified Rankin Score
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or who have other causes of neurological disability
Measured: 90 days after treatment
Procedure Time
Total procedure time from insertion of Route 92 Reperfusion System to final angiogram
Measured: Procedure
Procedure-Related SAEs
Serious Adverse Events related to the interventional procedure
Measured: Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start27 Sep 2019
- Primary completion22 Nov 2021
- Study completion24 Feb 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Route 92 Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stefan Brew, MBChB, MHB, Principal investigator, Auckland City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05429658
- Sponsor's protocol ID
- CIP 0605
- Acronym
- SUMMITNZ
- Status last verified
- Jun 2022
- First submitted
- 16 Jun 2022
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm, Interventional Clinical Trial to Evaluate the Safety and Effectiveness of the Route 92 Medical MonoPoint Reperfusion System for Aspiration Embolectomy in Acute Ischemic Stroke Patients
- ClinicalTrials.gov ID
- NCT05429658
- Acronym / sponsor ID
- SUMMITNZ / CIP 0605
- Conditions
- Acute Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Route 92 Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Sep 2019 (actual)
- Primary completion
- 22 Nov 2021 (actual)
- Study completion
- 24 Feb 2022 (actual)
- First posted
- 23 Jun 2022 (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.
The objective of the study is to evaluate the safety and effectiveness of the Route 92 Medical Monopoint Reperfusion System with the Hi Point 88 and HiPoint 70 Reperfusion Catheters when used to aspirate emboli in acute ischemic stroke patients.
Detailed description
The objective of the study is to evaluate the safety and effectiveness of the Route 92 Medical Monopoint Reperfusion System with the Hi Point 88 and HiPoint 70 Reperfusion Catheters when used to aspirate emboli in acute ischemic stroke patients.
The study design is an interventional, prospective, single-arm, open label clinical trial.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thrombectomy | Experimental | Device: ThrombectomyAspiration of clot with large bore catheter in acute ischemic stroke patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The consent process has been completed with the subject, Legally Authorized Representative, or two physician best interest and consent is documented
- Age >18 years
- Clinical signs consistent with an acute ischemic stroke
- Baseline National Institutes of Health Stroke Scale (NIHSS) score >= 6
- Pre-stroke modified Rankin Score (mRS) <= 2
Key exclusion criteria (13 listed)
- Known pregnancy or breast feeding
- Known comorbidity that may complicate treatment or prevent improvement or follow-up
- Known life expectancy < 12 months
- Known history of severe allergy to contrast medium
- Subject known to have suffered a stroke in the past 90 days
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 |
|---|---|---|
| ThrombectomyThe Route 92 Medical Reperfusion System is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease within the internal carotid, middle cerebral, basilar and vertebral arteries. | Device | Thrombectomy |
Primary outcome
Effectiveness
Time frame: Procedure
The primary effectiveness endpoint is arterial revascularization as measured by a modified Thrombolysis in Cerebrovascular Infarction (mTICI) score of 2b or greater at the end of angiography after all endovascular treatments.
Device-related peri-procedural complications
Time frame: Procedure
dissection or perforation
Symptomatic Intracranial Cerebral Hemorrhage (SICH)
Time frame: 24 hour
defined as type 2 parenchymal hemorrhage with a deterioration in National Institutes of Health Stroke Scale [NIHSS] score of >=4 points
Embolization to a previously uninvolved territory
Time frame: Procedure
Embolization to a previously uninvolved territory
4 secondary outcomes
NIHSS score
Time frame: 24 hours after treatment
Modified Rankin Score
Time frame: 90 days after treatment
Procedure Time
Time frame: Procedure
Procedure-Related SAEs
Time frame: Procedure
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 28 Mar 2024.
- 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.
Stefan Brew, MBChB, MHB principal investigator
Auckland City Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thrombectomy in people with Acute Ischemic Stroke, run by Route 92 Medical, Inc. at 2 sites in New Zealand.
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 9 inclusion and 13 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 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in New Zealand. 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?
Effectiveness (time frame: Procedure). The study lists 4 primary outcomes in all. 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 28 Mar 2024.