Safety Study of the Rapid System for Acute Ischemic Stroke

Acute Ischemic Stroke Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01404403
• Other study ID #: 002-07-01-RR
• Status: Completed
• Phase: Phase 1
• First received: July 26, 2011
• Last updated: November 4, 2013
• Start date: August 2011
• Est. completion date: October 2013

Study information

• Verified date: November 2013
• Source: Rapid Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

This is a safety study of the Rapid System for acute ischemic stroke.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Stroke

Intervention

Device:
• Rapid System

Locations

Country	Name	City	State
Sweden	Karolinska Hospital	Stockholm	Solna

Sponsors (1)

Lead Sponsor	Collaborator
Rapid Medical

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants with Adverse Device Effects (ADEs) Percentage of participants with Adverse Device Effects (ADEs)Percentage		12 patients	Yes