Trial Outcomes & Findings for Percutaneous Recanalization in Ischemic Stroke Management (PRIISM): A Feasibility Clinical Study (NCT NCT00810095)

Last Updated: 2012-07-26

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

40 participants

Primary outcome timeframe

Immediately postprocedure

Results posted on

2012-07-26

Participant Flow

Participant milestones

Participant milestones
Measure	MindFrame System Treatment Group All participants with acute ischemic stroke who were treated with the 1st generation MindFrame System of neurothrombotic stent retrievers. The first generation MindFrame System was a self-expanding nitinol stent retriever mounted on a hypotube delivery wire and delivered to the occlusion site via a 0.027 inch microcatheter. Eligible patients were aged 18-80 years, had a baseline NIHSS score of 6-30, had a thrombotic occlusion of the ICA, MCA (M1 or M2) or basilar arteries, and could be treated within 6 hours of stroke onset.
Overall Study STARTED	40
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Percutaneous Recanalization in Ischemic Stroke Management (PRIISM): A Feasibility Clinical Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Group n=40 Participants All participants treated with the Test System
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants
Age, Categorical >=65 years	24 Participants n=5 Participants
Age Continuous	63.8 years STANDARD_DEVIATION 13.6 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Region of Enrollment Sweden	23 participants n=5 Participants
Region of Enrollment Germany	14 participants n=5 Participants
Region of Enrollment Poland	3 participants n=5 Participants
Mean Baseline National Institutes of Health Stroke Scale (NIHSS) score	16.5 NIHSS units STANDARD_DEVIATION 4.7 • n=5 Participants
Median Baseline NIHSS score	16 NIHSS units n=5 Participants

PRIMARY outcome

Timeframe: Immediately postprocedure

Population: All participants treated with the Test System

Outcome measures

Outcome measures
Measure	Treatment Group n=40 Participants All participants treated with the Test System
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.	75 percentage of participants

PRIMARY outcome

Timeframe: Immediately postprocedure

Population: Percentage of participants who achieved (TIMI/TICI 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

Outcome measures

Outcome measures
Measure	Treatment Group n=40 Participants All participants treated with the Test System
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.	82.5 percentage of participants

PRIMARY outcome

Timeframe: 90 days postprocedure

Population: Percentage of participants achieving a Modified Rankin Scale score of 0-2 at 90 days postprocedure.

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.

Outcome measures

Outcome measures
Measure	Treatment Group n=40 Participants All participants treated with the Test System
Clinical Success	47.5 percentage of participants

SECONDARY outcome

Timeframe: Treatment to 90 days postprocedure

Population: Per protocol analysis of all participants treated with the 1st generation MindFrame System of neurothrombotic stent retrievers.

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.

Outcome measures

Outcome measures
Measure	Treatment Group n=40 Participants All participants treated with the Test System
Number of Device-related Serious Adverse Events	2 events

Adverse Events

Treatment Group

Serious events: 14 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment Group n=40 participants at risk All participants treated with the Test System
Nervous system disorders Intracranial hemorrhage	15.0% 6/40 • Number of events 6 • All adverse events up to and including the 90-day follow-up
General disorders Death	20.0% 8/40 • Number of events 8 • All adverse events up to and including the 90-day follow-up
Nervous system disorders Disorientation	2.5% 1/40 • Number of events 2 • All adverse events up to and including the 90-day follow-up
Nervous system disorders Malignant infarction	2.5% 1/40 • Number of events 1 • All adverse events up to and including the 90-day follow-up

Other adverse events

Other adverse events
Measure	Treatment Group n=40 participants at risk All participants treated with the Test System
Vascular disorders Epistaxis	7.5% 3/40 • Number of events 3 • All adverse events up to and including the 90-day follow-up
Respiratory, thoracic and mediastinal disorders Pneumonia	7.5% 3/40 • Number of events 3 • All adverse events up to and including the 90-day follow-up
Renal and urinary disorders Urinary Tract Infection	15.0% 6/40 • Number of events 6 • All adverse events up to and including the 90-day follow-up

Additional Information

Dr. Thomas J. McCarthy

MindFrame, Inc .

Phone: 949-204-0806

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place