Percutaneous Recanalization in Ischemic Stroke Management in Europe Observational Registry (PRIISM2)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
MindFrame, Inc.
ClinicalTrials.gov Identifier:
NCT01560247
First received: March 20, 2012
Last updated: April 3, 2012
Last verified: April 2012

March 20, 2012
April 3, 2012
January 2012
September 2014   (final data collection date for primary outcome measure)
  • Procedural Efficacy [ Time Frame: Immediate postprocedure ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    The rate of device-related serious adverse events
  • Clinical Efficacy [ Time Frame: 90 days postprocedure ] [ Designated as safety issue: No ]
    The rate of modified Rankin Scale (mRS) score 0-2 at 90 days
  • Procedural Efficacy [ Time Frame: Immediate postprocedure ] [ Designated as safety issue: No ]
    The ability of the MindFrame System to restore blood flow by removing thrombus and establishing final TICI 2b or 3 flow
  • Safety [ Time Frame: 90 days postprocedure ] [ Designated as safety issue: Yes ]
    The rate of device-related serious adverse events
  • Clinical Efficacy [ Time Frame: 90 days postprocedure ] [ Designated as safety issue: No ]
    The rate of MRS score 0-2 at 90 days
Complete list of historical versions of study NCT01560247 on ClinicalTrials.gov Archive Site
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Percutaneous Recanalization in Ischemic Stroke Management in Europe Observational Registry
Percutaneous Recanalization in Ischemic Stroke Management in Europe Observational Registry

To determine the revascularization rate, clinical efficacy and safety of the CE-marked MindFrame System in ischemic stroke patients

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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".

Ischemic Stroke
Procedure: Mechanical thrombectomy
Mechanical thrombectomy using a MindFrame device
Other Names:
  • MindFrame
  • Capture
  • Flow
Treatment Group
Subjects in whom a MindFrame Device was employed for restoration of flow and clot removal
Intervention: Procedure: Mechanical thrombectomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1000
December 2014
September 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinical diagnosis of ischemic stroke for whom the physician has prescribed mechanical thrombectomy as appropriate therapy

Exclusion Criteria:

  • Intracranial hemorrhage
Both
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No
Contact information is only displayed when the study is recruiting subjects
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NCT01560247
EU-PRIISM-02
No
MindFrame, Inc.
MindFrame, Inc.
Not Provided
Principal Investigator: Michael Soderman, MD, PhD Karolinska Institutet
MindFrame, Inc.
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP