Diagnostic Accuracy for Hemodynamically ICAS of MR-FFR Co... | NCT05631470

Studies
Diagnostic Accuracy for Hemodynamically ICAS of MR-FFR Comparing With Pressure-wire-based FFR.

NCT05631470

Sponsor

Xuanwu Hospital, Beijing

Status

Completed

Last Update Posted

Apr 27, 2023Actual

Enrollment

42Actual

Phase

Not provided

Conditions

Stroke, Ischemic
Intracranial Atherosclerosis

Interventions

MR screening

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

Jan 2023

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

Jun 18, 2019Actual

Primary Completion Date

Mar 1, 2023Actual

Completion Date

Mar 1, 2023Actual

First Submitted Date

Nov 21, 2022

First Submission Date that Met QC Criteria

Nov 21, 2022

First Posted Date

Nov 30, 2022Actual

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

Apr 25, 2023

Last Update Posted Date

Apr 27, 2023Actual

Name	Class
National Key Research and Development Project, China	UNKNOWN

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 aim of this study was to determine the diagnostic accuracy of MR-FFR to detect functionally significant ICAS comparing with pressure-wire-based FFR.

Detailed Description

This study will perform a head-to-head comparison between MR-FFR and pressure-wire-based FFR in patients with ICAS. Pressure-wire-based FFR will be used as the gold standard for intravascular pressure gradient measurement. The efficacy and safety of non-invasive FFR will be assessed in this study.

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

42Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Enrolled		Participants with ICAS will be scheduled for both MR screening and pressure-wire-based FFR measurement.	Diagnostic Test: MR screening

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MR screening	Diagnostic Test	This study is to compare the results of MR-FFR with pressure-wired-based FFR measurement.	Enrolled

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diagnostic accuracy of MR-FFR measurement.	The consistency of the two groups in the interpretation of hemodynamic conditions across the ICAS lesion.	3 days

Secondary Outcomes

Measure	Description	Time Frame
The rate of all-cause stroke and mortality.		3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients aged 18 years or older.
Patients with transient ischemic attack (TIA) or nondisabling ischemic stroke caused by a focal ICAS lesion located in intracranial anterior circulation (intracranial internal carotid artery and their major branches).
50% to 99% stenosis (calculated by modified WASID method) of responsible arterial occlusion, confirmed by digital subtraction angiography (DSA).
Informed of the study protocol and objectives.

Exclusion Criteria:

Non-atherosclerotic MCA stenosis
Combined with moderate or severe stenosis of other extracranial and intracranial arteries
Previous endovascular treatment or surgery for cerebrovascular diseases
Large cerebral infarction (more than 1/2 MCA perfusion area)
Combined with other neurological diseases, such as aneurysm, arteriovenous malformation, tumor, hydrocephalus, cerebral trauma, cerebral hemorrhage, multiple sclerosis, epilepsy and intracranial infection.
Vascular abnormality or stunting, resulting in the impossibility of endovascular intervention
Liver and kidney dysfunction, or severe allergy to the contrast agent
Severe coagulation dysfunction
Pregnancy or in the preparation for pregnancy
Patients who cannot tolerate or do not allow MR screening, including metal implanting and claustrophobia
Patients with severe dementia or mental disorders, who cannot cooperate with examination

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

Patients with symptomatic ICAS resorting to endovascular therapy in our center were recruited consecutively.

Sampling Method

Non-Probability Sample

ID	Term
D000083242	Ischemic Stroke
D002537	Intracranial Arteriosclerosis

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