Gadolinium-Enhanced Extracranial MRA Prior to Mechanical... | NCT03971552

Studies
Gadolinium-Enhanced Extracranial MRA Prior to Mechanical Thrombectomy Is Not Associated With an Improved Procedure Speed

NCT03971552

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Status

Completed

Last Update Posted

Jun 3, 2019Actual

Enrollment

912Actual

Phase

Not provided

Conditions

Stroke

Interventions

gadolinium-enhanced extracranial magnetic resonance angiogram

Countries

Not provided

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

May 2019

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

Jan 1, 2012Actual

Primary Completion Date

Dec 31, 2017Actual

Completion Date

Apr 1, 2018Actual

First Submitted Date

May 26, 2019

First Submission Date that Met QC Criteria

May 31, 2019

First Posted Date

Jun 3, 2019Actual

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

May 31, 2019

Last Update Posted Date

Jun 3, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The objective was to assess if performing a pre-intervention gadolinium-enhanced extracranial magnetic resonance angiogram (MRA) in addition to intracranial vascular imaging was associated with improved thrombectomy time metrics.

Consecutive patients (912) treated by mechanical thrombectomy (MT) at a large comprehensive stroke center between January 2012 and December 2017 who were screened using pre-intervention MRI were included. Patient's characteristics and procedural data were collected. Analyses were performed to compare mechanical thrombectomy speed, efficacy, complications, and clinical outcomes between patients with and without pre-intervention gadolinium-enhanced extracranial MRA.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

912Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
gadolinium-enhanced extracranial magnetic resonance angiogram	Procedure	288 of the 912 acute ischemic stroke patients received gadolinium-enhanced extracranial MRA additionally to the standardized stroke MRI imaging protocol.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
time from groin puncture to clot contact	in minute time from onset to recanalization complications [embolic or hemorrhagic]	1 day

Secondary Outcomes

Measure	Description	Time Frame
modified Rankin Score		3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Acute ischemic stroke

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Acute ischemic stroke (AIS) patients who underwent magnetic resonance imaging (MRI) based screening for acute neurovascular evaluation and who underwent mechanical thrombectomy (MT) at one comprehensive stroke center.

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided