REperfusion Therapy for Acute Ischemic STrOke Due to Larg... | NCT05311605

Studies
REperfusion Therapy for Acute Ischemic STrOke Due to Large aRtEry Occlusion

NCT05311605

Sponsor

Beijing Tiantan Hospital

Status

Unknown status

Last Update Posted

Mar 21, 2024Actual

Enrollment

1,600Estimated

Phase

Not provided

Conditions

Stroke
Vascular Occlusion
Endovascular Treatment
Mechanical Thrombectomy
Perfusion Imaging

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 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 23, 2023Actual

Primary Completion Date

Sep 30, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Mar 28, 2022

First Submission Date that Met QC Criteria

Mar 28, 2022

First Posted Date

Apr 5, 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

Mar 19, 2024

Last Update Posted Date

Mar 21, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yunyun Xiong, Professor of Neurology and Stroke Center, Beijing Tiantan HospitalPrincipal Investigator

Lead Sponsor

Beijing Tiantan HospitalOTHER

Collaborators

Name	Class
National Natural Science Foundation of China	OTHER_GOV
Beijing Municipal Science & Technology Commission	OTHER
Beijing Municipal Administration of Hospitals	OTHER_GOV

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 the study was to establish a clinical and advanced imaging database of acute ischemic stroke patients treated with mechanical thrombectomy due to large vessel occlusion of anterior circulation within 24 hours from stroke onset in China, and to investigate the predictors and potential mechanisms of futile recanalization after mechanical thrombectomy.

Detailed Description

The time-window of mechanical thrombectomy for ischemic stroke has extended from 4.5 hours to 24 hours based on the results of the DAWN and DEFUSE 3 trials. However, evidence on the effectiveness and safety of mechanical thrombectomy within 24 hours in the real-world is insufficient.

This is a multi-center, prospective, registry cohort study that acute ischemic stroke patients treated with mechanical thrombectomy due to large vessel occlusion of anterior circulation within 24 hours from stroke onset in China. A retrospective dataset was also build in these stroke centers for analysis. A total of 1600 patients with advanced imaging data were anticipated to be enrolled.

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

Retention

Enrollment

1,600Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Favorable functional outcome	proportion of mRS score 0-2 at 3 months. The modified Rankin Scale (mRS) has a minimum value of 0 and maximum value of 6. Higher value indicated worse functional outcome	3 months from stroke onset

Secondary Outcomes

Measure	Description	Time Frame
Excellent functional outcome at 90 days	proportion of mRS score 0-1 at 3 months	3 months from stroke onset
Ordinal distribution of mRS at 90 days	Number of participants with the ordinal distribution of mRS at 90 days

Other Outcomes

Measure	Description	Time Frame
Infarction volume at 24 hours	infarction volume: volume of the tissue with CBF <30% or ADC<600×10-6mm2/s	24 hours after thrombectomy completed
symptomatic intracerebral hemorrhage at 36 hours	symptomatic intracerebral hemorrhage based on Heidelberg criterion

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Older than 18 years;
Perfusion imaging completed including CTA+CTP or MRA+PWI+DWI before thrombectomy
Large vessel occlusion of cerebral anterior circulation (ICA, MCA-M1 or MCA-M2) confirmed by CTA or MRA, planned to receive or received stenting or aspiration thrombectomy
Time intervals ≤ 24 hours from stroke onset to groin puncture.(fulfilled the inclusion of DAWN or DEFUSE 3 trial if the time intervals from stroke onset to groin puncture was ≥6 hours)
mRS score ≤2 before admission
Informed consent obtained for longitudinal enrolled patients, waived of consent for retrospectively included cases

Exclusion Criteria:

Had a history of infective disease, immunity disease, radiotherapy at head or neck, carotid dissection or other carotid disease.
Unable to receive CT or MR scan due to heart failure, cardiac pacemaker, metal implants or claustrophobia, etc.
Unable to be injected with contrast agent due to allergy, renal dysfunction, etc.
Unlikely to adhere to the study protocol or follow-up ( life expectancy ≤ 3 months)
Already participated in other drug trials

Accepts Healthy Volunteers

Not provided

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

ischemic stroke patients that received mechanical thrombectomy due to large vessel occlusion of anterior circulation within 24 hours from stroke onset and had perfusion imaging both before and after thrombectomy.

Sampling Method

Probability Sample

Name	Role	Phone	Extension	Email
Yunyun Xiong, MD, PhD	Contact	00861059975213		xiongyunyun@bjtth.org

Name	Affiliation	Role
Yunyun Xiong, MD, PhD	Beijing Tiantan Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Yunyun Xiong	Recruiting	Beijing			China

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke
D000083242	Ischemic Stroke

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided