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Safety Study of the Rapid System for Acute Ischemic Stroke

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ClinicalTrials.gov Identifier: NCT01404403
Recruitment Status : Completed
First Posted : July 28, 2011
Last Update Posted : November 5, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This is a safety study of the Rapid System for acute ischemic stroke.

Condition or disease Intervention/treatment Phase
Acute Ischemic Stroke Device: Rapid System Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : August 2011
Primary Completion Date : October 2013
Study Completion Date : October 2013
Arms and Interventions

Arm Intervention/treatment
Stroke patients Device: Rapid System


Outcome Measures

Primary Outcome Measures :
  1. Percentage of participants with Adverse Device Effects (ADEs) Percentage of participants with Adverse Device Effects (ADEs)Percentage [ Time Frame: 12 patients ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01404403


Locations
Sweden
Karolinska Hospital
Stockholm, Solna, Sweden, 171 76
Sponsors and Collaborators
Rapid Medical
More Information

Responsible Party: Rapid Medical
ClinicalTrials.gov Identifier: NCT01404403     History of Changes
Other Study ID Numbers: 002-07-01-RR
First Posted: July 28, 2011    Key Record Dates
Last Update Posted: November 5, 2013
Last Verified: November 2013

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