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Safety Study of the Rapid System for Acute Ischemic Stroke

This study is currently recruiting participants.
Verified July 2011 by Rapid Medical
Sponsor:
Information provided by:
Rapid Medical
ClinicalTrials.gov Identifier:
NCT01404403
First received: July 26, 2011
Last updated: August 10, 2011
Last verified: July 2011
History of Changes
  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: Open Label
Primary Purpose: Treatment

Further study details as provided by Rapid Medical:

Intervention Details:
    Device: Rapid System
    N/A
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01404403

Contacts
Contact: Danel Mayer danel@rapid-medical.com

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

No publications provided

Responsible Party: Danel Mayer, Rapid Medical Ltd
ClinicalTrials.gov Identifier: NCT01404403     History of Changes
Other Study ID Numbers: 002-07-01-RR
Study First Received: July 26, 2011
Last Updated: August 10, 2011
Health Authority: Sweden: Medical Products Agency

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

ClinicalTrials.gov processed this record on May 21, 2013