Safety Study of the Rapid System for Acute Ischemic Stroke | NCT01404403

Studies
Safety Study of the Rapid System for Acute Ischemic Stroke

NCT01404403

Sponsor

Rapid Medical

Status

Completed

Last Update Posted

Nov 5, 2013Estimated

Enrollment

12Actual

Phase

Phase 1

Conditions

Acute Ischemic Stroke

Interventions

Rapid System

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2011

Primary Completion Date

Oct 2013Actual

Completion Date

Oct 2013Actual

First Submitted Date

Jul 26, 2011

First Submission Date that Met QC Criteria

Jul 26, 2011

First Posted Date

Jul 28, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 4, 2013

Last Update Posted Date

Nov 5, 2013Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Label	Type	Description	Intervention Names
Stroke patients	Other		Device: Rapid System

Name	Type	Description	Arm Group Labels	Other Names
Rapid System	Device		Stroke patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of participants with Adverse Device Effects (ADEs) Percentage of participants with Adverse Device Effects (ADEs)Percentage		12 patients

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Karolinska Hospital		Stockholm	Solna	171 76	Sweden

Condition Browse Module

MeSH Terms

ID	Term
D000083242	Ischemic Stroke

Ancestor Terms

ID	Term
D020521	Stroke
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided