Safety Study of the Rapid System for Acute Ischemic Stroke

Phase 1

Completed

• Conditions: Acute Ischemic Stroke
• Interventions: Device: Rapid System

• Registration Number: NCT01404403
• Lead Sponsor: Rapid Medical

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-07-26
• Study First Submitted QC: 2011-07-26
• Study First Posted: 2011-07-28
• Study Start: 2011-08
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-04
• Last Update Posted: 2013-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stroke patients	Rapid System	-

Primary Outcome Measures

Name	Time	Method
Percentage of participants with Adverse Device Effects (ADEs) Percentage of participants with Adverse Device Effects (ADEs)Percentage	12 patients

Trial Locations

Locations (1)

Karolinska Hospital; 🇸🇪 Stockholm, Solna, Sweden