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Clinical Trials/NCT01404403
NCT01404403CompletedPhase 1

Safety Study of the Rapid System for Acute Ischemic Stroke

Rapid Medical2 sites in 1 country12 target enrollmentStarted: August 1, 2011Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Status
Completed
Sponsor
Enrollment
12
Locations
2
Primary Endpoint
Percentage of participants with Adverse Device Effects (ADEs) Percentage of participants with Adverse Device Effects (ADEs)Percentage
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
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

Outcomes

Primary Outcomes

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

Time Frame: 12 patients

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Rapid Medical
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

Loading locations...

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