Safety Study of the Rapid System for Acute Ischemic Stroke

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

Completed

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Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Karolinska Hospital

Stockholm, Solna, 171 76, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rapid System

Device

Primary outcomes

Percentage of participants with Adverse Device Effects (ADEs) Percentage of participants with Adverse Device Effects (ADEs)Percentage

Time frame: 12 patients

Sponsors and collaborators

Lead sponsor

Rapid Medical

Industry

Registry information

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2013
First posted: Jul 28, 2011
Registry last updated: Nov 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed