Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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 ] [ 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
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

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 processed this record on March 03, 2015