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

Resource links provided by NLM:

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 ] [ Designated as safety issue: Yes ]

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
Genders Eligible for Study:   Both
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
Please refer to this study by its identifier: NCT01404403

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

No publications provided

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
Health Authority: Sweden: Medical Products Agency

Additional relevant MeSH terms:
Cerebral Infarction
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia processed this record on April 15, 2014