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
  Purpose

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


Condition Intervention
Ischemic Stroke
Procedure: Mechanical thrombectomy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Percutaneous Recanalization in Ischemic Stroke Management in Europe Observational Registry

Resource links provided by NLM:


Further study details as provided by MindFrame, Inc.:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 1000
Study Start Date: January 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Treatment Group
Subjects in whom a MindFrame Device was employed for restoration of flow and clot removal
Procedure: Mechanical thrombectomy
Mechanical thrombectomy using a MindFrame device
Other Names:
  • MindFrame
  • Capture
  • Flow

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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".

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Intracranial hemorrhage
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01560247

Sponsors and Collaborators
MindFrame, Inc.
Investigators
Principal Investigator: Michael Soderman, MD, PhD Karolinska Institutet
  More Information

No publications provided

Responsible Party: MindFrame, Inc.
ClinicalTrials.gov Identifier: NCT01560247     History of Changes
Other Study ID Numbers: EU-PRIISM-02
Study First Received: March 20, 2012
Last Updated: April 3, 2012
Health Authority: Germany: Ethics Commission
Sweden: Institutional Review Board

Keywords provided by MindFrame, Inc.:
Stroke
Ischemic Stroke
Revascularization
Mechanical thrombectomy
Neurothrombectomy

Additional relevant MeSH terms:
Ischemia
Stroke
Cerebral Infarction
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on July 26, 2014