- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01560247
Percutaneous Recanalization in Ischemic Stroke Management in Europe Observational Registry (PRIISM2)
April 3, 2012 updated by: MindFrame, Inc.
To determine the revascularization rate, clinical efficacy and safety of the CE-marked MindFrame System in ischemic stroke patients
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
1000
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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".
Description
Inclusion Criteria:
- Clinical diagnosis of ischemic stroke for whom the physician has prescribed mechanical thrombectomy as appropriate therapy
Exclusion Criteria:
- Intracranial hemorrhage
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Treatment Group
Subjects in whom a MindFrame Device was employed for restoration of flow and clot removal
|
Mechanical thrombectomy using a MindFrame device
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Immediate postprocedure
|
Safety
Time Frame: 90 days postprocedure
|
The rate of device-related serious adverse events
|
90 days postprocedure
|
Clinical Efficacy
Time Frame: 90 days postprocedure
|
The rate of modified Rankin Scale (mRS) score 0-2 at 90 days
|
90 days postprocedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michael Soderman, MD, PhD, Karolinska Institutet
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Anticipated)
September 1, 2014
Study Completion (Anticipated)
December 1, 2014
Study Registration Dates
First Submitted
March 20, 2012
First Submitted That Met QC Criteria
March 21, 2012
First Posted (Estimate)
March 22, 2012
Study Record Updates
Last Update Posted (Estimate)
April 5, 2012
Last Update Submitted That Met QC Criteria
April 3, 2012
Last Verified
April 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EU-PRIISM-02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ischemic Stroke
-
Nordsjaellands HospitalRigshospitalet, Denmark; Metropolitan University CollegeCompletedTransient Ischemic Attack | Stroke, Ischemic | Stroke HemorrhagicDenmark
-
University of CalgaryThe George Institute for Global Health, AustraliaNot yet recruitingAcute Ischemic Stroke AIS | Stroke, Acute, Stroke Ischemic | Stroke AcuteCanada, Australia
-
Second Affiliated Hospital, School of Medicine,...Shanghai Zhongshan Hospital; First Affiliated Hospital of Wenzhou Medical University and other collaboratorsRecruitingAcute Ischemic Stroke and Transient Ischemic AttacksChina
-
Medtronic Cardiac Rhythm and Heart FailureMedtronic Bakken Research CenterCompletedCryptogenic Symptomatic Transient Ischemic Attack | Cryptogenic Ischemic StrokeNetherlands, United States, France, Belgium, Germany, Sweden, Italy, Austria, Canada, Denmark, Finland, Greece, Slovakia, Spain
-
University Hospital, BrestCompletedStroke, Ischemic | Stroke HemorrhagicFrance
-
Sheffield Teaching Hospitals NHS Foundation TrustUnknownFatigue | Stroke, Ischemic | Stroke HemorrhagicUnited Kingdom
-
Umbria Bioengineering TechnologiesRecruitingStroke, Ischemic | Stroke HemorrhagicItaly
-
BayerRecruitingAcute Non-cardioembolic Ischemic Stroke | Prevention of Ischemic Stroke | High-risk Transient Ischemic AttackUnited States, Switzerland, Belgium, Australia, Sweden, Canada, Taiwan, Spain, Korea, Republic of, Latvia, Israel, Malaysia, China, Greece, Japan, Turkey, Netherlands, Romania, United Kingdom, Portugal, Hungary, Italy, Brazil, France, S... and more
-
University of AlbertaCompletedTransient Ischemic Attack | Minor Ischemic StrokeCanada
-
Stephanie HarrisonActive, not recruitingTransient Ischemic Attack | Stroke, IschemicUnited Kingdom
Clinical Trials on Mechanical thrombectomy
-
ThrombX MedicalNot yet recruitingIschemic Stroke
-
phenox Inc.CompletedIschemia | Pathologic Processes | Cardiovascular Diseases | Vascular Diseases | Cerebrovascular Disorders | Brain Diseases | Central Nervous System Diseases | Nervous System Diseases | Stroke, Ischemic | Stroke, AcuteUnited States, Germany
-
Hospital Clinic of BarcelonaGermans Trias i Pujol Hospital; Hospital Universitario Ramon y Cajal; Hospital... and other collaboratorsRecruitingStroke | Thrombectomy | IschemicSpain
-
University Hospital, MontpellierRecruitingStroke | Large Vessel Occlusion | IschemicFrance
-
Stryker NeurovascularCompletedIschemic StrokeUnited States, Spain, France, Switzerland, Belgium, Canada, Czechia, Germany, Italy, Korea, Republic of, United Kingdom
-
University Hospital, MontpellierCompleted
-
The Cleveland ClinicCompletedAcute Ischemic StrokeUnited States
-
Paul J. GagneRecruitingAcute Deep Venous Thrombosis of Ileofemoral VeinUnited States
-
SurModics, Inc.RecruitingPeripheral Arterial Disease | Acute Limb IschemiaUnited States
-
Inje University Haeundae Paik HospitalKorean Neuroendovascular SocietyEnrolling by invitationAcute Cerebral Ischemia Requiring for Mechanical ThrombectomyKorea, Republic of