Occlusive StrokeNCT03438565
SURE 18 Registry -Asahi Chikai Black 18 in LVO Stroke
An observational study of Occlusive Stroke, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
The objective of this study is to obtain post market data on the Asahi Chikai Black 18 neurovascular guidewire in the treatment of intracranial large vessel occlusive stroke. This will be compared to a historical control that will include the prior 50 consecutive patients fitting the same selection criteria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Occlusive Stroke
- What is being tested?
- Asahi Chikai Black 18 neurovascular guidewire
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2018to 1 Feb 2020
- How long will I take part?
- 90 Days
- Phase
- Observational
- 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
Study population: For the prospective portion, patients will be enrolled if their doctor decides to treat them with the ASAHI Chikai Black 18 Neurovascular Guidewire. For the retrospective portion, 50 consecutive mechanical thrombectomy cases will be evaluated.
Who may be able to join
- Male or female patients presenting with acute anterior cerebral circulation large vessel occlusive stroke
- ASPECT score 5 or better
- Occlusion of the ICA terminus and M1 MCA
- Favorable CT perfusion with clinical/radiologic mismatch
- Last known well out to 24 hours
- Age limit >18 years
- Baseline mRS 0-3
Who cannot join
- Intracranial hemorrhage
- ASPECTS (Alberta stroke program early CT score) <5
- Unfavorable CT perfusion
- Baseline mRS 4 or greater
- Large vessel occlusive stroke with tandem lesion of the cervical internal carotid artery or posterior circulation
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Safety and Utility Profile of the Asahi Chikai Black 18 neuRovascular guidewirE in Large Vessel Occlusive Stroke: SURE 18 Registry
The objective of this study is to obtain post market data on the Asahi Chikai Black 18 neurovascular guidewire in the treatment of intracranial large vessel occlusive stroke. This will be compared to a historical control that will include the prior 50 consecutive patients fitting the same selection criteria.
Read the detailed description
This is a prospective registry collecting information on 50 patients treated with the ASAHI Chikai Black 18 microguidewire. Patients will undergo mechanical thrombectomy for acute large vessel occlusive stroke within the anterior circulation as is standard of care.
Additionally, this study will have a retrospective portion which will examine 50 consecutive patients who meet inclusion/exclusion criteria treated for acute anterior circulation large vessel occlusive stroke prior to the initiation of the Sure -18 Registry. This retrospective cohort will be 50 consecutive mechanical thrombectomy cases performed using any neurovascular microguidewire other than the device under study (Asahi Chikai Black 18) at the same enrolling centers leading up to December 10, 2018.
- Conditions
- Occlusive Stroke
- Being tested
- Asahi Chikai Black 18 neurovascular guidewire
- Keywords
- Asahi Chikai Black 18 Neurovascular Guidewire, Prospective, Retrospective
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asahi Chikai Black 18 neurovascular guidewireDevice
The Asahi Chikai Black 18 microguidewire employs a reverse tapered shaft with 0.018" tip and 0.014" proximal shaft, which provides additional support and tactile feedback.
| Study group | Role | What they receive |
|---|---|---|
| Participants with intracranial large vessel occlusive stroke | 50 patients who have been treated with the Asahi Chikai Black 18 neurovascular guidewire. Receives: Device: Asahi Chikai Black 18 neurovascular guidewire | |
| Historical Control Group | The historical control will include 50 retrospective consecutive patients (who fulfill inclusion and exclusion criteria) treated for acute anterior circulation large vessel occlusive stroke prior to the initiation of the Sure -18 registry. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to clot engagement
Time from guide catheter placement within the target ICA to clot engagement
Measured: 30 days
Number of device related serious adverse events
Safety profile as measured by number of Intra-procedural device related serious adverse events
Measured: Day 1
Secondary outcomes (3)
Modified Rankin Scale (mRS)
0 No symptoms at all
- No significant disability despite symptoms; able to carry out all usual duties and activities
- Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
- Moderate disability; requiring some help, but able to walk without assistance
- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
- Severe disability; bedridden, incontinent and requiring constant nursing care and attention
- Dead
Measured: 90 days post procedure
Change in NIH Stroke Scale (NIHSS)
The score for each ability is a number between 0 (normal functioning) to 4 (completely impaired). The NIHSS has 11 different items and the highest possible score is 42. The higher the score, the more impaired a stroke patient is.
Measured: 24 hours
Number of neurovascular guidewires required per case
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start18 Mar 2018
- Primary completion1 Feb 2020
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occlusive StrokeStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 100 participants (actual)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Asahi Intecc USA Inc
- Responsible party
- Principal investigator, Reade A De Leacy, Icahn School of Medicine at Mount Sinai
- Investigators
- Reade De Leacy, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03438565
- Sponsor's protocol ID
- GCO 17-2723
- Status last verified
- Mar 2020
- First submitted
- 13 Feb 2018
- Last updated
- 10 Mar 2020
- 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 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Utility Profile of the Asahi Chikai Black 18 neuRovascular guidewirE in Large Vessel Occlusive Stroke: SURE 18 Registry
- ClinicalTrials.gov ID
- NCT03438565
- Acronym / sponsor ID
- GCO 17-2723
- Conditions
- Occlusive Stroke
- Keywords
- Asahi Chikai Black 18 Neurovascular Guidewire, Prospective, Retrospective
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Asahi Intecc USA Inc
- Study start
- 18 Mar 2018 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 19 Feb 2018 (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 this study is to obtain post market data on the Asahi Chikai Black 18 neurovascular guidewire in the treatment of intracranial large vessel occlusive stroke. This will be compared to a historical control that will include the prior 50 consecutive patients fitting the same selection criteria.
Detailed description
This is a prospective registry collecting information on 50 patients treated with the ASAHI Chikai Black 18 microguidewire. Patients will undergo mechanical thrombectomy for acute large vessel occlusive stroke within the anterior circulation as is standard of care.
Additionally, this study will have a retrospective portion which will examine 50 consecutive patients who meet inclusion/exclusion criteria treated for acute anterior circulation large vessel occlusive stroke prior to the initiation of the Sure -18 Registry. This retrospective cohort will be 50 consecutive mechanical thrombectomy cases performed using any neurovascular microguidewire other than the device under study (Asahi Chikai Black 18) at the same enrolling centers leading up to December 10, 2018.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 90 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with intracranial large vessel occlusive stroke | – | Device: Asahi Chikai Black 18 neurovascular guidewire50 patients who have been treated with the Asahi Chikai Black 18 neurovascular guidewire. |
| Historical Control Group | – | –The historical control will include 50 retrospective consecutive patients (who fulfill inclusion and exclusion criteria) treated for acute anterior circulation large vessel occlusive stroke prior to the initiation of the Sure -18 registry. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- For the prospective portion, patients will be enrolled if their doctor decides to treat them with the ASAHI Chikai Black 18 Neurovascular Guidewire. For the retrospective portion, 50 consecutive mechanical thrombectomy cases will be evaluated.
Key inclusion criteria (7 listed)
- Male or female patients presenting with acute anterior cerebral circulation large vessel occlusive stroke
- ASPECT score 5 or better
- Occlusion of the ICA terminus and M1 MCA
- Favorable CT perfusion with clinical/radiologic mismatch
- Last known well out to 24 hours
Key exclusion criteria (5 listed)
- Intracranial hemorrhage
- ASPECTS (Alberta stroke program early CT score) <5
- Unfavorable CT perfusion
- Baseline mRS 4 or greater
- Large vessel occlusive stroke with tandem lesion of the cervical internal carotid artery or posterior circulation
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 |
|---|---|---|
| Asahi Chikai Black 18 neurovascular guidewireThe Asahi Chikai Black 18 microguidewire employs a reverse tapered shaft with 0.018" tip and 0.014" proximal shaft, which provides additional support and tactile feedback. | Device | Participants with intracranial large vessel occlusive stroke |
Primary outcome
Time to clot engagement
Time frame: 30 days
Time from guide catheter placement within the target ICA to clot engagement
Number of device related serious adverse events
Time frame: Day 1
Safety profile as measured by number of Intra-procedural device related serious adverse events
3 secondary outcomes
Modified Rankin Scale (mRS)
Time frame: 90 days post procedure
Change in NIH Stroke Scale (NIHSS)
Time frame: 24 hours
Number of neurovascular guidewires required per case
Time frame: Day 1
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 10 Mar 2020.
- 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.
Reade De Leacy, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Occlusive Stroke, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
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 7 inclusion and 5 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 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Time to clot engagement (time frame: 30 days). The study lists 2 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 10 Mar 2020.