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

June 19, 2012 updated by: MindFrame, Inc.

A Feasibility Trial to Evaluate the MindFrame System in the Recanalization of Occluded Vessels in Patients Experiencing an Ischemic Stroke

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Heidelberg, Germany
        • University of Heidelberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. NIHSS 6 to 30 within 6 hours of symptom onset
  2. Pre-stroke Modified Rankin Score ≤ 2
  3. Large Vessel Occlusion
  4. Patient/patient guardian is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluation.

  5. 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:

  1. Pregnancy
  2. Glucose <50mg/dL
  3. Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR>3.0
  4. Patient received heparin within 48 hours with a PTT greater than 2 times the lab normal.
  5. Patient has baseline platelets < 30,000
  6. Evidence of rapidly improving neurological signs of stroke at time of enrollment
  7. Coma
  8. Pre-existing neurological or psychiatric disease that could confound the study results
  9. Known severe allergy to contrast media or nitinol
  10. Patient has severe sustained hypertension
  11. CT/MRI scan reveals significant mass effect with midline shift
  12. Patient's angiogram shows an arterial stenosis >50% proximal to the embolus.
  13. Patient's anticipated life expectancy is less than 3 months
  14. Participation in another clinical investigation that could confound the evaluation of the study device

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Arm
Device: MindFrame System
Thrombectomy Catheter designed to rapidly restore blood flow in patients experiencing an ischemic stroke
Other Names:
  • Intervention
  • Mechanical Thrombectomy
  • IRIIS System
  • Clot
  • Thrombus
  • Ischemic Stroke
  • Neurovascular

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Immediately postprocedure

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.
Time Frame: Immediately postprocedure

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
Time Frame: 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.
90 days postprocedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Device-related Serious Adverse Events
Time Frame: Treatment to 90 days postprocedure
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.
Treatment to 90 days postprocedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MindFrame, Inc.

Investigators

  • Principal Investigator: Martin Bendszus, MD, PhD, Heidelberg University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

December 15, 2008

First Submitted That Met QC Criteria

December 15, 2008

First Posted (Estimate)

December 17, 2008

Study Record Updates

Last Update Posted (Estimate)

July 26, 2012

Last Update Submitted That Met QC Criteria

June 19, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EU-PRIISM-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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