Stroke, AcutePROSPR-SEANCT03364023
Post-Market Registry Of Stroke Patients Treated With Medtronic Neuro Thrombectomy Devices to Collect Real World Data in South East Asia
An observational study of Stroke, Acute, run by Medtronic Neurovascular Clinical Affairs at 10 sites in 3 countries.
Trial summary
The purpose of this post-market registry is to collect real-world data associated with the use of Medtronic market-released neurothrombectomy devices in acute ischemic stroke (AIS) patients from countries in South East Asia. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke, Acute
- What is being tested?
- Neurothrombectomy
- Type of treatment
- Medical device
- How many people
- 183 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 1 Jan 2018to 2 Jul 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: AIS patients treated with a Medtronic market-released neurothrombectomy device.
Who may be able to join
- Subject/subject's legally authorized representative has given Informed Consent according to country regulations, and/or EC requirements.
- Subject has experienced an Acute Ischemic Stroke due to large intracranial vessel occlusion in at least one of the following intracranial vessels: internal carotid artery (ICA), M1 and M2 segments of the middle cerebral artery (MCA), basilar, and vertebral arteries.
- Subject has been or will be treated with a Medtronic market-released neurothrombectomy device as the initial device used to remove the thrombus.
- Subject is willing to participate in a 90-day follow-up visit.
- Treatment within 8 hours of stroke symptom onset (defined as stroke onset to access puncture).
Who cannot join
- 1. Concurrent participation in another mechanical neurothrombectomy device trial or any other clinical trial with an active treatment arm or where the study procedure or treatment might confound the study analysis.
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
Vietnam4 sites
108 Military Central Hospital
Hanoi
Bach Mai Hospital
Hanoi
Ho Chi Minh City Medicine and Pharmacy University
Ho Chi Minh City
The People's 115 Hospital
Ho Chi Minh City
Singapore3 sites
National Neuroscience Institute
Singapore
National University Hospital
Singapore
Singapore General Hospital
Singapore
Thailand3 sites
Prasat Neurology Institute
Bangkok
Ramathibodi Hospital
Bangkok
Siriraj Hospital
Bangkok
About this study
Official title: Post-Market Registry Of Stroke Patients Treated With Medtronic Neuro Thrombectomy Devices to Collect Real World Data in South East Asia (PROSPR-SEA)
The purpose of this post-market registry is to collect real-world data associated with the use of Medtronic market-released neurothrombectomy devices in acute ischemic stroke (AIS) patients from countries in South East Asia.
Read the detailed description
This is a prospective, multi-center, non-randomized, observational registry designed to collect real world data associated with the use of Medtronic market-released neurothrombectomy devices in acute ischemic stroke (AIS) patients from countries in South East Asia, including Singapore, Thailand and Vietnam. The primary objective of this registry is to assess clinical outcomes associated with the use of these devices in patients experiencing AIS due to large intracranial vessel occlusion within 8 hours of symptom onset. This registry may enroll up to 500 patients.
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402 (j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402 (j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.)
- Conditions
- Stroke, Acute
- Being tested
- Neurothrombectomy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeurothrombectomyDevice
Medtronic Market-Released Neurothrombectomy Device
| Study group | Role | What they receive |
|---|---|---|
| Acute Ischemic Stroke Patients | Acute Ischemic Stroke (AIS) patients treated with Medtronic Market-Released Neurothrombectomy Device Receives: Device: Neurothrombectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin Scale (mRS) at 90 Days
mRS is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke.
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
Secondary outcomes (3)
Number of Participants With Symptomatic Intracranial Hemorrhage (sICH) at 24 Hrs ± 8 Hrs Post Procedure
Number of participants with symptomatic Intracranial hemorrhage (sICH) is defined as >/= 4 points worsening from baseline on the National Institutes of Health Stroke Scale (NIHSS) associated with an image finding of intra-cranial hemorrhage (i.e., intracerebral or intraventricular) at 24 +/- 8 hrs post procedure.
The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. NIHSS scores range from 0 - 42. A score of 0 indicates no stroke symptoms. Higher scores indicate incremental levels of neurological impairment.
Measured: 24 hrs ± 8 hrs post procedure
All-Cause Mortality Through 90 Days Post Procedure
Death through 90 days post procedure classified as neurological or non-neurological, with event leading to death.
Measured: 90 Days Post Procedure
Incidence of Emboli in New Territory (ENT) at 24 Hrs ± 8 Hrs Post Procedure
Emboli in New Territory (ENT) is defined as embolization territories outside of the target downstream territory.
Measured: 24 hrs ± 8 hrs post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
- Study start1 Jan 2018
- Primary completion2 Jul 2019
- Study completion2 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stroke, AcuteStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Neurovascular Clinical Affairs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ka Sing Lawrence Wong, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03364023
- Sponsor's protocol ID
- MDT16066SOLSEA
- Acronym
- PROSPR-SEA
- Status last verified
- Jul 2020
- First submitted
- 1 Dec 2017
- Last updated
- 19 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No individual participant data will be available.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Registry Of Stroke Patients Treated With Medtronic Neuro Thrombectomy Devices to Collect Real World Data in South East Asia (PROSPR-SEA)
- ClinicalTrials.gov ID
- NCT03364023
- Acronym / sponsor ID
- PROSPR-SEA / MDT16066SOLSEA
- Conditions
- Stroke, Acute
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Medtronic Neurovascular Clinical AffairsIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 2 Jul 2019 (actual)
- Study completion
- 2 Jul 2019 (actual)
- First posted
- 6 Dec 2017 (actual)
- Results
- Posted 19 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this post-market registry is to collect real-world data associated with the use of Medtronic market-released neurothrombectomy devices in acute ischemic stroke (AIS) patients from countries in South East Asia.
Detailed description
This is a prospective, multi-center, non-randomized, observational registry designed to collect real world data associated with the use of Medtronic market-released neurothrombectomy devices in acute ischemic stroke (AIS) patients from countries in South East Asia, including Singapore, Thailand and Vietnam. The primary objective of this registry is to assess clinical outcomes associated with the use of these devices in patients experiencing AIS due to large intracranial vessel occlusion within 8 hours of symptom onset. This registry may enroll up to 500 patients.
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402 (j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402 (j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute Ischemic Stroke Patients | – | Device: NeurothrombectomyAcute Ischemic Stroke (AIS) patients treated with Medtronic Market-Released Neurothrombectomy Device |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- AIS patients treated with a Medtronic market-released neurothrombectomy device.
Key inclusion criteria (5 listed)
- Subject/subject's legally authorized representative has given Informed Consent according to country regulations, and/or EC requirements.
- Subject has experienced an Acute Ischemic Stroke due to large intracranial vessel occlusion in at least one of the following intracranial vessels: internal carotid artery (ICA), M1 and M2 segments of the middle cerebral artery (MCA), basilar, and vertebral arteries.
- Subject has been or will be treated with a Medtronic market-released neurothrombectomy device as the initial device used to remove the thrombus.
- Subject is willing to participate in a 90-day follow-up visit.
- Treatment within 8 hours of stroke symptom onset (defined as stroke onset to access puncture).
Key exclusion criteria (1 listed)
- 1. Concurrent participation in another mechanical neurothrombectomy device trial or any other clinical trial with an active treatment arm or where the study procedure or treatment might confound the study analysis.
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 |
|---|---|---|
| NeurothrombectomyMedtronic Market-Released Neurothrombectomy Device | Device | Acute Ischemic Stroke Patients |
Primary outcome
Modified Rankin Scale (mRS) at 90 Days
Time frame: 90 Days Post Procedure
mRS is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke. 0 No symptoms at all 1. No significant disability despite symptoms; able to carry out all usual duties and activities 2. Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 3. Moderate disability; requiring some help, but able to walk without assistance 4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5. Severe disability; bedridden, incontinent and requiring constant nursing care and attention 6. Dead
3 secondary outcomes
Number of Participants With Symptomatic Intracranial Hemorrhage (sICH) at 24 Hrs ± 8 Hrs Post Procedure
Time frame: 24 hrs ± 8 hrs post procedure
All-Cause Mortality Through 90 Days Post Procedure
Time frame: 90 Days Post Procedure
Incidence of Emboli in New Territory (ENT) at 24 Hrs ± 8 Hrs Post Procedure
Time frame: 24 hrs ± 8 hrs post procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No individual participant data will be available.
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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.
Ka Sing Lawrence Wong, MD principal investigator
Chinese University of Hong Kong
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Acute, run by Medtronic Neurovascular Clinical Affairs at 10 sites in 3 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 5 inclusion and 1 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 19 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Vietnam, Singapore, Thailand. 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?
Yes. Results are posted in the registry (first posted 19 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Modified Rankin Scale (mRS) at 90 Days (time frame: 90 Days Post Procedure). 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 19 Aug 2020.