Back to resultsPercutaneous Recanalization in Ischemic Stroke Management (PRIISM): A Feasibility Clinical Study (PRIISM)
Primary Purpose
Ischemic Stroke
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
MindFrame System
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Stroke focused on measuring Cerebral Infarction, Stroke, Vascular Diseases, Central Nervous System Diseases, Penumbra, Functional Outcome, Aphasia, Hemiplegia, Left sided weakness, Right Sided weakness
Eligibility Criteria
Inclusion Criteria:
- NIHSS 6 to 30 within 6 hours of symptom onset
- Pre-stroke Modified Rankin Score ≤ 2
- Large Vessel Occlusion
- Patient/patient guardian is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluation.
Patients must meet at least one of the following criteria:
- Eligible for Intravenous rt-PA
- Eligible for Intra-arterial rt-PA - IA rt-PA initiated within 6 hours of symptom onset
- Patient presents within 6 hours of symptom onset
Exclusion Criteria:
- Pregnancy
- Glucose <50mg/dL
- Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR>3.0
- Patient received heparin within 48 hours with a PTT greater than 2 times the lab normal.
- Patient has baseline platelets < 30,000
- Evidence of rapidly improving neurological signs of stroke at time of enrollment
- Coma
- Pre-existing neurological or psychiatric disease that could confound the study results
- Known severe allergy to contrast media or nitinol
- Patient has severe sustained hypertension
- CT/MRI scan reveals significant mass effect with midline shift
- Patient's angiogram shows an arterial stenosis >50% proximal to the embolus.
- Patient's anticipated life expectancy is less than 3 months
- Participation in another clinical investigation that could confound the evaluation of the study device
Sites / Locations
- University of Heidelberg
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment Arm
Arm Description
Outcomes
Primary Outcome Measures
Technical Device Success by as Assessed by the Percentage of Participants Which Established at Least TIMI 2 Flow Upon Deployment of the System Across the Occlusion and Within 30 Minutes of Placing the Guide Catheter.
TIMI Flow is a perfusion scoring system from 0-3 referring to levels of blood flow assessed during reperfusion procedures:
TIMI 0 flow (no perfusion) TIMI 1 flow (penetration without perfusion) TIMI 2 flow (partial reperfusion) TIMI 3 flow (complete perfusion) is normal flow
Procedural Success as Determined by the Overal Percentage of Patients Who Achieve TIMI Grade 2/3 Flow, With or Without the Use of Adjuvant Therapy, in All Treatable Vessels as Confirmed by the Final Post Treatment Angiogram.
TIMI Flow is a scoring system from 0-3 referring to levels of blood flow assessed during percutaneous coronary angioplasty:
TIMI 0 flow (no perfusion) TIMI 1 flow (penetration without perfusion) TIMI 2 flow (partial reperfusion) TIMI 3 flow (complete perfusion) is normal flow
Clinical Success
Clinical Success as determined by achievment of a Modified Rankin Scale score of 0-2 at 90 days postprocedure. The modified Rankin Scale is a measure of a patient's level of functional independence with 0=normal and 6-death. Patients with a score of 0-2 are considered functionally independent.
Secondary Outcome Measures
Number of Device-related Serious Adverse Events
Evaluation of the safety of using the MindFrame System based on device-related serious adverse event(s). Device-related serious adverse events are defined as vessel perforation, intramural arterial dissection, device-related symptomatic intracranial hemorrhage, and significant embolization in a previously uninvolved arterial territory.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00810095
Brief Title
Percutaneous Recanalization in Ischemic Stroke Management (PRIISM): A Feasibility Clinical Study
Acronym
PRIISM
Official Title
A Feasibility Trial to Evaluate the MindFrame System in the Recanalization of Occluded Vessels in Patients Experiencing an Ischemic Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MindFrame, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary study objective is to assess the feasibility of using the MindFrame System to safely and effectively restore blood flow in a thrombotic neurovascular occlusion in patients experiencing an ischemic stroke.
Detailed Description
The objective of PRIISM is to assess the feasibility of using the MindFrame System to safely and effectively restore blood flow in a thrombotic neurovascular occlusion in patients with acute ischemic stroke. Safety will be assessed by the device-related serious event rate as it compares to other similar therapies. The events include but are not limited to symptomatic hemorrhage, vessel dissection, embolization and overall morbidity and mortality. Target vessels include the basilar, internal carotid and middle cerebral (M1 and M2 segments) arteries.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
Keywords
Cerebral Infarction, Stroke, Vascular Diseases, Central Nervous System Diseases, Penumbra, Functional Outcome, Aphasia, Hemiplegia, Left sided weakness, Right Sided weakness
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Arm
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
MindFrame System
Other Intervention Name(s)
IRIIS System, Clot, Thrombus, Mechanical Thrombectomy, Ischemic Stroke, Intervention, Neurovascular
Intervention Description
Thrombectomy Catheter designed to rapidly restore blood flow in patients experiencing an ischemic stroke
Primary Outcome Measure Information:
Title
Technical Device Success by as Assessed by the Percentage of Participants Which Established at Least TIMI 2 Flow Upon Deployment of the System Across the Occlusion and Within 30 Minutes of Placing the Guide Catheter.
Description
TIMI Flow is a perfusion scoring system from 0-3 referring to levels of blood flow assessed during reperfusion procedures:
TIMI 0 flow (no perfusion) TIMI 1 flow (penetration without perfusion) TIMI 2 flow (partial reperfusion) TIMI 3 flow (complete perfusion) is normal flow
Time Frame
Immediately postprocedure
Title
Procedural Success as Determined by the Overal Percentage of Patients Who Achieve TIMI Grade 2/3 Flow, With or Without the Use of Adjuvant Therapy, in All Treatable Vessels as Confirmed by the Final Post Treatment Angiogram.
Description
TIMI Flow is a scoring system from 0-3 referring to levels of blood flow assessed during percutaneous coronary angioplasty:
TIMI 0 flow (no perfusion) TIMI 1 flow (penetration without perfusion) TIMI 2 flow (partial reperfusion) TIMI 3 flow (complete perfusion) is normal flow
Time Frame
Immediately postprocedure
Title
Clinical Success
Description
Clinical Success as determined by achievment of a Modified Rankin Scale score of 0-2 at 90 days postprocedure. The modified Rankin Scale is a measure of a patient's level of functional independence with 0=normal and 6-death. Patients with a score of 0-2 are considered functionally independent.
Time Frame
90 days postprocedure
Secondary Outcome Measure Information:
Title
Number of Device-related Serious Adverse Events
Description
Evaluation of the safety of using the MindFrame System based on device-related serious adverse event(s). Device-related serious adverse events are defined as vessel perforation, intramural arterial dissection, device-related symptomatic intracranial hemorrhage, and significant embolization in a previously uninvolved arterial territory.
Time Frame
Treatment to 90 days postprocedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
NIHSS 6 to 30 within 6 hours of symptom onset
Pre-stroke Modified Rankin Score ≤ 2
Large Vessel Occlusion
Patient/patient guardian is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluation.
Patients must meet at least one of the following criteria:
Eligible for Intravenous rt-PA
Eligible for Intra-arterial rt-PA - IA rt-PA initiated within 6 hours of symptom onset
Patient presents within 6 hours of symptom onset
Exclusion Criteria:
Pregnancy
Glucose <50mg/dL
Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR>3.0
Patient received heparin within 48 hours with a PTT greater than 2 times the lab normal.
Patient has baseline platelets < 30,000
Evidence of rapidly improving neurological signs of stroke at time of enrollment
Coma
Pre-existing neurological or psychiatric disease that could confound the study results
Known severe allergy to contrast media or nitinol
Patient has severe sustained hypertension
CT/MRI scan reveals significant mass effect with midline shift
Patient's angiogram shows an arterial stenosis >50% proximal to the embolus.
Patient's anticipated life expectancy is less than 3 months
Participation in another clinical investigation that could confound the evaluation of the study device
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Bendszus, MD, PhD
Organizational Affiliation
Heidelberg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Heidelberg
City
Heidelberg
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Percutaneous Recanalization in Ischemic Stroke Management (PRIISM): A Feasibility Clinical Study
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