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Safety Study of the Rapid System for Acute Ischemic Stroke

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01404403
First Posted: July 28, 2011
Last Update Posted: November 5, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Rapid Medical
  Purpose
This is a safety study of the Rapid System for acute ischemic stroke.

Condition Intervention Phase
Acute Ischemic Stroke Device: Rapid System Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Further study details as provided by Rapid Medical:

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

Enrollment: 12
Study Start Date: August 2011
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Stroke patients Device: Rapid System

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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 Submitted: July 26, 2011
First Posted: July 28, 2011
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