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

NCT ID: NCT00810095

Last Updated: 2012-07-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2011-04-30

Brief Summary

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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

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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.

Conditions

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Ischemic Stroke

Keywords

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment Arm

Group Type EXPERIMENTAL

MindFrame System

Intervention Type DEVICE

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

Interventions

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MindFrame System

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

Intervention Type DEVICE

Other Intervention Names

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IRIIS System Clot Thrombus Mechanical Thrombectomy Ischemic Stroke Intervention Neurovascular

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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MindFrame, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martin Bendszus, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Heidelberg University

Locations

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University of Heidelberg

Heidelberg, , Germany

Site Status

Countries

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Poland Germany

Other Identifiers

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EU-PRIISM-01

Identifier Type: -

Identifier Source: org_study_id