NCT04823481

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

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

Study Start

First participant enrolled

January 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 30, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

December 12, 2022

Status Verified

December 1, 2022

Enrollment Period

12 months

First QC Date

March 26, 2021

Last Update Submit

December 9, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • Administration of recanalization treatment before hospital admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Fondation Adolphe de Rothschild

Paris, Île-de-France Region, 75019, France

Location

MeSH Terms

Conditions

Ischemic StrokeThrombosis

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesEmbolism and Thrombosis

Study Officials

  • Pierre Seners, MD,PhD

    Hôpital Fondation Adolphe de Rothschild

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2021

First Posted

March 30, 2021

Study Start

January 1, 2021

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

December 12, 2022

Record last verified: 2022-12

Locations