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

NCT00810095 | Completed Phase 2 Results DMC

• 1 other identifier: EU-PRIISM-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke

Keywords

Cerebral Infarction; Stroke; Vascular Diseases; Central Nervous System Diseases; Penumbra; Functional Outcome; Aphasia; Hemiplegia; Left sided weakness; Right Sided weakness

Outcome Measures

Primary Outcomes (3)

• 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

  Immediately postprocedure

• 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

  Immediately postprocedure

• 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.

  90 days postprocedure

Secondary Outcomes (1)

• Number of Device-related Serious Adverse Events

  Treatment to 90 days postprocedure

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Device: MindFrame System

Interventions

MindFrame System DEVICE

Thrombectomy Catheter designed to rapidly restore blood flow in patients experiencing an ischemic stroke

Also known as: IRIIS System, Clot, Thrombus, Mechanical Thrombectomy, Ischemic Stroke, Intervention, Neurovascular

Treatment Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MindFrame, Inc.: lead

Study Sites (1)

University of Heidelberg

Heidelberg, Germany

Location

MeSH Terms

Conditions

Ischemic Stroke; Cerebral Infarction; Stroke; Vascular Diseases; Central Nervous System Diseases; Aphasia; Hemiplegia

Interventions

Methods

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Nervous System Diseases; Cardiovascular Diseases; Brain Infarction; Brain Ischemia; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Paralysis

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

• Title: Dr. Thomas J. McCarthy
• Organization: MindFrame, Inc .

tmccarthy@mindframeinc.com

949-204-0806

Study Officials

• Martin Bendszus, MD, PhD

  Heidelberg University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2008
• First Posted: December 17, 2008
• Study Start: March 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: July 26, 2012
• Results First Posted: July 26, 2012

Record last verified: 2012-06

Locations

DE (1)