REperfusion Therapy for Acute Ischemic STrOke Due to Large aRtEry Occlusion (RESTORE)

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Vascular Occlusion; Endovascular Treatment; Mechanical Thrombectomy; Perfusion Imaging

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.

• Study Type: Observational
• Enrollment (Estimated): 1600

Contacts and Locations

• Study Contact: Name: Yunyun Xiong, MD, PhD; Phone Number: 00861059975213; Email: xiongyunyun@bjtth.org

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Yunyun Xiong
    • Contact: Yunyun Xiong; Email: xiongyunyun@bjtth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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	3 months from stroke onset
EQ-5D score at at 90 days	EQ-5D score at 3 months. EuroQol Five Dimensions Questionnaire scale (EQ-5D score) has a minimum value of 0 and maximum value of 100. Lower value indicated worse functional outcome	3 months from stroke onset
Neurological improvement at 24 hours	NIHSS score <=1 or improvement of NIHSS score>=4 compared with baseline NIHSS. National Institution Health Stroke Scale (NIHSS) has a minimum value of 0 and maximum value of 45. Higher value indicated worse severity of neurological impairment.	24 hours from stroke onset
recanalization post-operation	proportion of eTICI 2b50/2c/3. Thrombectomy is a surgical operation using a retrieve stent or aspiration catheter to remove the thrombus inside an occluded vessel and achieve recanalization.The eTICI is a scale to assess the degree of recanalization. So, once the surgeon thought he completed the thrombectomy, he needed to perform a cerebral angiography to assess the degree of recanalization using eTICI.	(Day 0) immediately the surgeon thought the thrombectomy completed and performed a second cerebral angiography .
recanalization at 24 hours	proportion of eTICI 2b50/2c/3	24 hours after thrombectomy completed

Other Outcome Measures

Outcome Measure	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	36 hours after thrombectomy completed
Mortality at 90 days	Mortality of all-cause	90 days after thrombectomy completed

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Collaborators: National Natural Science Foundation of China; Beijing Municipal Science & Technology Commission; Beijing Municipal Administration of Hospitals
• Investigators: Principal Investigator: Yunyun Xiong, MD, PhD, Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2023
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: March 28, 2022
• First Submitted That Met QC Criteria: March 28, 2022
• First Posted (Actual): April 5, 2022

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: endovascular treatment; ischemic stroke; mechanical thrombectomy; perfusion imaging; vascular occlusion
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: KY-2022-029-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No