Safety Study of the Rapid System for Acute Ischemic Stroke

November 4, 2013 updated by: Rapid Medical
This is a safety study of the Rapid System for acute ischemic stroke.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

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

  • Sweden
    • Solna
      • Stockholm, Solna, Sweden, 171 76
        • Karolinska hospital

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 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Stroke patients
Device: Rapid System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of participants with Adverse Device Effects (ADEs) Percentage of participants with Adverse Device Effects (ADEs)Percentage
Time Frame: 12 patients
12 patients

Collaborators and Investigators

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

Sponsor

Rapid Medical

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

August 1, 2011

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

July 26, 2011

First Submitted That Met QC Criteria

July 26, 2011

First Posted (Estimate)

July 28, 2011

Study Record Updates

Last Update Posted (Estimate)

November 5, 2013

Last Update Submitted That Met QC Criteria

November 4, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 002-07-01-RR

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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