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Safety Study of the Rapid System for Acute Ischemic Stroke

NCT ID: NCT01404403

Last Updated: 2013-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2013-10-31

Brief Summary

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This is a safety study of the Rapid System for acute ischemic stroke.

Detailed Description

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Conditions

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Acute Ischemic Stroke

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Stroke patients

Group Type OTHER

Rapid System

Intervention Type DEVICE

Interventions

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Rapid System

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients ≥18 to \<85 years old
* Pre stroke modified Rankin Scale (mRS) of ≤2
* A signed informed consent by patient or a legally acceptable representative

Exclusion Criteria

* Pre-stroke life expectancy of less than 6 months
* Current participation in another investigational drug or device study
* Pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rapid Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Karolinska Hospital

Stockholm, Solna, Sweden

Site Status

Countries

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Sweden

Other Identifiers

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002-07-01-RR

Identifier Type: -

Identifier Source: org_study_id