Back to resultsSafety Study of the Rapid System for Acute Ischemic Stroke
Primary Purpose
Acute Ischemic Stroke
Status
Completed
Phase
Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
Rapid System
Sponsored by
About this trial
This is an interventional treatment trial for Acute Ischemic Stroke
Eligibility 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
Sites / Locations
- Karolinska Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Stroke patients
Arm Description
Outcomes
Primary Outcome Measures
Percentage of participants with Adverse Device Effects (ADEs) Percentage of participants with Adverse Device Effects (ADEs)Percentage
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01404403
Brief Title
Safety Study of the Rapid System for Acute Ischemic Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rapid Medical
4. Oversight
5. Study Description
Brief Summary
This is a safety study of the Rapid System for acute ischemic stroke.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stroke patients
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Rapid System
Primary Outcome Measure Information:
Title
Percentage of participants with Adverse Device Effects (ADEs) Percentage of participants with Adverse Device Effects (ADEs)Percentage
Time Frame
12 patients
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Karolinska Hospital
City
Stockholm
State/Province
Solna
ZIP/Postal Code
171 76
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Safety Study of the Rapid System for Acute Ischemic Stroke
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