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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MindFrame, Inc.
ClinicalTrials.gov Identifier:
NCT00810095
First received: December 15, 2008
Last updated: June 19, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Ischemic Stroke
Device: MindFrame System
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Feasibility Trial to Evaluate the MindFrame System in the Recanalization of Occluded Vessels in Patients Experiencing an Ischemic Stroke

Resource links provided by NLM:


Further study details as provided by MindFrame, Inc.:

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. [ Time Frame: Immediately postprocedure ] [ Designated as safety issue: No ]

    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. [ Time Frame: Immediately postprocedure ] [ Designated as safety issue: No ]

    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 [ Time Frame: 90 days postprocedure ] [ Designated as safety issue: No ]
    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 [ Time Frame: Treatment to 90 days postprocedure ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 40
Study Start Date: March 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Arm Device: MindFrame System
Thrombectomy Catheter designed to rapidly restore blood flow in patients experiencing an ischemic stroke
Other Names:
  • IRIIS System
  • Clot
  • Thrombus
  • Mechanical Thrombectomy
  • Ischemic Stroke
  • Intervention
  • Neurovascular

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00810095

Locations
Germany
University of Heidelberg
Heidelberg, Germany
Sponsors and Collaborators
MindFrame, Inc.
Investigators
Principal Investigator: Martin Bendszus, MD, PhD Heidelberg University
  More Information

No publications provided

Responsible Party: MindFrame, Inc.
ClinicalTrials.gov Identifier: NCT00810095     History of Changes
Other Study ID Numbers: EU-PRIISM-01
Study First Received: December 15, 2008
Results First Received: March 21, 2012
Last Updated: June 19, 2012
Health Authority: Germany: Ethics Commission
Poland: Ethics Committee
Sweden: Institutional Review Board

Keywords provided by MindFrame, Inc.:
Cerebral Infarction
Stroke
Vascular Diseases
Central Nervous System Diseases
Penumbra
Functional Outcome
Aphasia
Hemiplegia
Left sided weakness
Right Sided weakness

Additional relevant MeSH terms:
Ischemia
Stroke
Cerebral Infarction
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on August 19, 2014