Ischemic StrokePRIISM2NCT01560247
Percutaneous Recanalization in Ischemic Stroke Management in Europe Observational Registry
An observational study of Ischemic Stroke, run by MindFrame, Inc..
Trial summary
To determine the revascularization rate, clinical efficacy and safety of the CE-marked MindFrame System in ischemic stroke patients Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Mechanical thrombectomy
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Dec 2014
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The purpose of this registry is to compile data in a "real world setting". All subjects in whom there is an attempt to use the device will be included in the registry. All subjects must be recruited according to the Mindframe System "Instructions For Use".
Who may be able to join
- Clinical diagnosis of ischemic stroke for whom the physician has prescribed mechanical thrombectomy as appropriate therapy
Who cannot join
- Intracranial hemorrhage
About this study
To determine the revascularization rate, clinical efficacy and safety of the CE-marked MindFrame System in ischemic stroke patients
Read the detailed description
To determine the revascularization rate, clinical efficacy and safety in a "real-world setting" of the CE-marked MindFrame System in ischemic stroke patients with thrombotic neurovascular occlusions caused by an embolus deemed appropriate for endovascular treatment. Target vessels include the basilar, internal carotid and middle cerebral (M1 and M2 segments) arteries.
- Conditions
- Ischemic Stroke
- Being tested
- Mechanical thrombectomy
- Keywords
- Stroke, Ischemic Stroke, Revascularization, Mechanical thrombectomy, Neurothrombectomy
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical thrombectomyProcedure or surgery
Also called MindFrame, Capture, Flow
Mechanical thrombectomy using a MindFrame device
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Subjects in whom a MindFrame Device was employed for restoration of flow and clot removal Receives: Procedure: Mechanical thrombectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural Efficacy
The ability of the MindFrame System to restore blood flow by removing thrombus and establishing final Thrombolysis in Cerebral Infarction (TICI) 2b or 3 perfusion
Measured: Immediate postprocedure
Safety
The rate of device-related serious adverse events
Measured: 90 days postprocedure
Clinical Efficacy
The rate of modified Rankin Scale (mRS) score 0-2 at 90 days
Measured: 90 days postprocedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2012 (estimated)
- Study startJan 2012
- Primary completionSep 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MindFrame, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Soderman, MD, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01560247
- Sponsor's protocol ID
- EU-PRIISM-02
- Acronym
- PRIISM2
- Status last verified
- Apr 2012
- First submitted
- 20 Mar 2012
- Last updated
- 5 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Recanalization in Ischemic Stroke Management in Europe Observational Registry
- ClinicalTrials.gov ID
- NCT01560247
- Acronym / sponsor ID
- PRIISM2 / EU-PRIISM-02
- Conditions
- Ischemic Stroke
- Keywords
- Stroke, Ischemic Stroke, Revascularization, Mechanical thrombectomy, Neurothrombectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- MindFrame, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 22 Mar 2012 (estimated)
- 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.
To determine the revascularization rate, clinical efficacy and safety of the CE-marked MindFrame System in ischemic stroke patients
Detailed description
To determine the revascularization rate, clinical efficacy and safety in a "real-world setting" of the CE-marked MindFrame System in ischemic stroke patients with thrombotic neurovascular occlusions caused by an embolus deemed appropriate for endovascular treatment. Target vessels include the basilar, internal carotid and middle cerebral (M1 and M2 segments) arteries.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | – | Procedure: Mechanical thrombectomySubjects in whom a MindFrame Device was employed for restoration of flow and clot removal |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The purpose of this registry is to compile data in a "real world setting". All subjects in whom there is an attempt to use the device will be included in the registry. All subjects must be recruited according to the Mindframe System "Instructions For Use".
Key inclusion criteria (1 listed)
- Clinical diagnosis of ischemic stroke for whom the physician has prescribed mechanical thrombectomy as appropriate therapy
Key exclusion criteria (1 listed)
- Intracranial hemorrhage
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 |
|---|---|---|
| Mechanical thrombectomyAlso: MindFrame, Capture, FlowMechanical thrombectomy using a MindFrame device | Procedure or surgery | Treatment Group |
Primary outcome
Procedural Efficacy
Time frame: Immediate postprocedure
The ability of the MindFrame System to restore blood flow by removing thrombus and establishing final Thrombolysis in Cerebral Infarction (TICI) 2b or 3 perfusion
Safety
Time frame: 90 days postprocedure
The rate of device-related serious adverse events
Clinical Efficacy
Time frame: 90 days postprocedure
The rate of modified Rankin Scale (mRS) score 0-2 at 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2012.
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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.
Michael Soderman, MD, PhD principal investigator
Karolinska Institutet
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, run by MindFrame, Inc..
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 1 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: status not confirmed, as of the sponsor's last update on 5 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Procedural Efficacy (time frame: Immediate postprocedure). The study lists 3 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 5 Apr 2012.