NCT01404403

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2011

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 28, 2011

Completed
4 days until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

November 5, 2013

Status Verified

November 1, 2013

Enrollment Period

2.2 years

First QC Date

July 26, 2011

Last Update Submit

November 4, 2013

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

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

    12 patients

Study Arms (1)

Stroke patients

OTHER
Device: Rapid System

Interventions

Rapid SystemDEVICE
Stroke patients

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pre-stroke life expectancy of less than 6 months
  • Current participation in another investigational drug or device study
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Hospital

Stockholm, Solna, 171 76, Sweden

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2011

First Posted

July 28, 2011

Study Start

August 1, 2011

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

November 5, 2013

Record last verified: 2013-11

Locations

SE(1)