NCT05864638

Brief Summary

A Multicenter Registry of Endovascular Treatment for Acute Ischemic Stroke.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
29mo left

Started May 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress56%
May 2023Aug 2028

First Submitted

Initial submission to the registry

April 13, 2023

Completed
27 days until next milestone

Study Start

First participant enrolled

May 10, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 18, 2023

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2028

Expected
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2028

Last Updated

January 27, 2025

Status Verified

January 1, 2025

Enrollment Period

5.3 years

First QC Date

April 13, 2023

Last Update Submit

January 23, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Functional outcome

    Shift (improvement) in scores on the modified Rankin scale (mRS) at 90 days (±7 days). The value range 0-6: higher scores mean a worse outcome.

    90days

Secondary Outcomes (6)

  • Dichotomized modified Rankin scale (mRS)

    90days

  • NIHSS at 24 hours

    24 hours post-procedure

  • NIHSS at 7 days

    7 days post procedure

  • Reperfusion outcome

    Immediately post-procedure

  • Early successful revascularization rate

    During procedure

  • +1 more secondary outcomes

Other Outcomes (5)

  • Death

    7 days and 90 days

  • Intracerebral hemorrhage(ICH)

    90 days

  • Procedure related complication

    within 30 days after procedure

  • +2 more other outcomes

Study Arms (1)

Endovascular treatment

Device: Endovascular treatment

Interventions

Endovascular treatment, such as mechanical thrombectomy with stent, aspiration catheter or stent assisted by intermediate aspiration catheter, as well as combination of mechanical thrombectomy with intra-arterial thrombolysis

Endovascular treatment

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All acute ischemic stroke patients receiving endovascular treatment

You may qualify if:

  • Acute ischemic stroke caused by anterior or posterior circulation vessel occlusion confirmed by computed tomography angiography (CTA) or magnetic resonance angiography (MRA) or digital subtraction angiography (DSA)
  • Undergo intravascular therapy (i.e. access to a cath lab and an arterial puncture)
  • The patient or his/her legal representative agreed to participate in the study and has signed the informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jianimin Liu

Shanghai, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

thrombus

MeSH Terms

Conditions

Ischemic StrokeThrombosis

Condition Hierarchy (Ancestors)

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

Study Officials

  • Jianimin Liu, M.D.

    Changhai Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pengfei Yang, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
90 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Cerebrovascular Disease Center

Study Record Dates

First Submitted

April 13, 2023

First Posted

May 18, 2023

Study Start

May 10, 2023

Primary Completion (Estimated)

August 30, 2028

Study Completion (Estimated)

August 31, 2028

Last Updated

January 27, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

Data can be shared with bona fide researchers after the publication of the main results, based on a submitted protocol to Oriental Collaboration group on Emerging Advanced therapy for Neurovascular diseases Consortium.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data sharing will be available from 12 months after the publication of the main results.
Access Criteria
1. The data sharing will be only for the purposes of health and medical research and within the constraints of the consent under which the data were originally gathered. 2. The Custodian of the Collection will not consider any Proposals for data sharing that unblind, or potentially unblind, randomised comparisons in active / ongoing trials. 3. Requesters should be employees of a recognised academic institution, health service organisation, commercial research organisation or from the pharmaceutical industry. Requesters must have experience in medical research. 4. Requesters must be able to demonstrate through their peer review publications in the area of interest their ability to carry out the proposed use of the requested dataset from a Collection. 5. The Requesters must not have a conflict of interest that may potentially influence their interpretation of any analyses
More information

Locations