Exploration and Establishment of an Early Warning System... | NCT07045987

Studies
Exploration and Establishment of an Early Warning System for Futile Reperfusion - A I S

NCT07045987

Sponsor

Xijing Hospital

Status

Enrolling by invitation

Last Update Posted

Jul 1, 2025Actual

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Acute Ischemic Stroke (AIS)
Endovascular Thrombectomy
Neurovascular Unit- Brain Lymphatic System

Interventions

Not provided

Countries

China

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

Mar 2025

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2025Actual

Primary Completion Date

May 31, 2028Estimated

Completion Date

May 31, 2029Estimated

First Submitted Date

Jun 23, 2025

First Submission Date that Met QC Criteria

Jun 23, 2025

First Posted Date

Jul 1, 2025Actual

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

Jun 23, 2025

Last Update Posted Date

Jul 1, 2025Actual

Name	Class
National Science and Technology Major Project	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 goal of this prospective cohort registration study is to establish an early warning system for futile recanalization in acute ischemic stroke by analyzing multi-omics information to identify key regulatory nodes and target molecules in ineffective recanalization.

The core issue addressed by this research is: Identifying key regulatory nodes and target molecules closely associated with futile recanalization, revealing the interactions among the neurovascular unit, peripheral immune cells, and the brain lymphatic system, as well as developing early diagnostic biomarkers and novel diagnostic technologies for futile recanalization.

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

Yes

Target Follow-Up Duration

3 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
3-month mRS score		From enrollment to the end of treatment at 3 months

Secondary Outcomes

Not provided

Other Outcomes

Measure	Description	Time Frame
All-cause mortality within 3 months		From enrollment to the end of treatment at 3months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1. Aged ≥18 years 2. Acute ischemic stroke confirmed by clinical and neuroimaging criteria (CT or MRI) 3. Clinical indication for thrombectomy 4. Provision of signed informed consent

Exclusion Criteria:

1. Preexisting dementia or severe disability (modified Rankin Scale score ≥3) 2. Cerebral vascular malformations, neoplasms, abscesses, or other significant non-ischemic brain pathologies 3. Life-limiting systemic comorbidities (e.g., end-stage organ failure, metastatic malignancies) with anticipated survival <6 months 4. Patient or legally authorized representative declined consent 5. Anticipated poor protocol adherence or loss to follow-up

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

Adults (>18y) with thrombectomy-eligible acute ischemic stroke confirmed by neuroimaging, meeting prespecified inclusion/exclusion criteria

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Luojun WANG		Xi’an	Shanxi	710077	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20075087	Result	Hussein HM, Georgiadis AL, Vazquez G, Miley JT, Memon MZ, Mohammad YM, Christoforidis GA, Tariq N, Qureshi AI. Occurrence and predictors of futile recanalization following endovascular treatment among patients with acute ischemic stroke: a multicenter study. AJNR Am J Neuroradiol. 2010 Mar;31(3):454-8. doi: 10.3174/ajnr.A2006. Epub 2010 Jan 14.
31831388

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