This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Safety Study of the Rapid System for Acute Ischemic Stroke

This study has been completed.
Information provided by (Responsible Party):
Rapid Medical Identifier:
First received: July 26, 2011
Last updated: November 4, 2013
Last verified: November 2013
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: 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


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

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01404403

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

Responsible Party: Rapid Medical Identifier: NCT01404403     History of Changes
Other Study ID Numbers: 002-07-01-RR
Study First Received: July 26, 2011
Last Updated: November 4, 2013

Additional relevant MeSH terms:
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia processed this record on August 16, 2017