Percutaneous Recanalization in Ischemic Stroke Management in Europe Observational Registry

Ischemic Stroke Clinical Trial

— PRIISM2  

Official title:

Percutaneous Recanalization in Ischemic Stroke Management in Europe Observational Registry

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01560247
• Other study ID #: EU-PRIISM-02
• Status: Active, not recruiting
• Phase: N/A
• First received: March 20, 2012
• Last updated: April 3, 2012
• Start date: January 2012
• Est. completion date: December 2014

Study information

• Verified date: April 2012
• Source: MindFrame, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics CommissionSweden: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: December 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Intracranial hemorrhage

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Procedure:
• Mechanical thrombectomy
Mechanical thrombectomy using a MindFrame device

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
MindFrame, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Immediate postprocedure	No
Primary	Safety	The rate of device-related serious adverse events	90 days postprocedure	Yes
Primary	Clinical Efficacy	The rate of modified Rankin Scale (mRS) score 0-2 at 90 days	90 days postprocedure	No