Acute Anterior or Posterior Cerebral Artery Occlusion Rec... | NCT04823481

Studies
Acute Anterior or Posterior Cerebral Artery Occlusion Recanalization Therapy and Relationships With Clinical Outcome (ACAPULCO)

NCT04823481

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Status

Completed

Last Update Posted

Dec 12, 2022Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Ischemic Stroke
Thrombi

Interventions

Not provided

Countries

France

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

Dec 2022

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, 2021Actual

Primary Completion Date

Dec 31, 2021Actual

Completion Date

Dec 31, 2021Actual

First Submitted Date

Mar 26, 2021

First Submission Date that Met QC Criteria

Mar 26, 2021

First Posted Date

Mar 30, 2021Actual

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

Dec 9, 2022

Last Update Posted Date

Dec 12, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Nearly 3% of patients with ischaemic stroke (IS) have an isolated occlusion of the anterior or posterior cerebral artery in the acute phase of the disease. In those patients, intravenous thrombolysis (IT) is indicated for 4.5 hours after symptoms onset. Due to a lack of data, mechanical thrombectomy (MT) is not considered as a gold standard to treat IS alone or in addition with IT. Therefore, observational studies are needed to understand the clinical evolution of patients with IS treated with IT and/or MT. The ACAPULCO retrospective observational study aims to highlight potential benefits of MT in those patients to improve their management and to propose targeted therapies in the future.

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

100Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinico-radiological evolution of IS patients with isolated occlusion of the anterior or posterior cerebral artery.	Good Neurological Condition Good neurological outcome (GNO) at 3 months will defined using the modified Rankin Scale (mRS). A normal/near normal outcome after procedure is associated with a mRS Scale score = 0-1 and severe disability/death is associated with a mRS Scale score = 5-6	90 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥ 18 and < 96
Clinical signs consistent with acute ischemic stroke
Patients who presented within 6 hours of stroke symptoms onset
Isolated occlusion of the anterior or the posterior artery

Exclusion Criteria:

Administration of recanalization treatment before hospital admission

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

95 Years

Standard Ages

AdultOlder Adult

Study Population

Subjects having clinical signs and imaging criteria consistent with acute ischemic stroke who presented within 6 hours of stroke symptoms onset with isolated occlusion of the anterior or the posterior artery.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pierre Seners, MD,PhD	Hôpital Fondation Adolphe de Rothschild	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital Fondation Adolphe de Rothschild		Paris	Île-de-France Region	75019	France

Condition Browse Module

MeSH Terms

ID	Term
D000083242	Ischemic Stroke
D013927	Thrombosis

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