REperfusion Therapy for Acute Ischemic STrOke Due to Large aRtEry Occlusion

Stroke Clinical Trial

— RESTORE  

Official title:

REperfusion Therapy for Acute Ischemic STrOke Due to Large aRtEry Occlusion

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05311605
• Other study ID #: KY-2022-029-01
• Status: Recruiting
• Start date: February 23, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Beijing Tiantan Hospital
• Contact: Yunyun Xiong, MD, PhD
• Phone: 00861059975213
• Email: xiongyunyun[@]bjtth.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1600
• Est. completion date: December 31, 2024
• Est. primary completion date: September 30, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endovascular Treatment
• Ischemic Stroke
• Mechanical Thrombectomy
• Perfusion Imaging
• Stroke
• Vascular Occlusion

Locations

Country	Name	City	State
China	Yunyun Xiong	Beijing

Sponsors (4)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital	Beijing Municipal Administration of Hospitals, Beijing Municipal Science & Technology Commission, National Natural Science Foundation of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	symptomatic intracerebral hemorrhage at 36 hours	symptomatic intracerebral hemorrhage based on Heidelberg criterion	36 hours after thrombectomy completed
Other	Mortality at 90 days	Mortality of all-cause	90 days after thrombectomy completed
Primary	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	Excellent functional outcome at 90 days	proportion of mRS score 0-1 at 3 months	3 months from stroke onset
Secondary	Ordinal distribution of mRS at 90 days	Number of participants with the ordinal distribution of mRS at 90 days	3 months from stroke onset
Secondary	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
Secondary	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
Secondary	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 .
Secondary	recanalization at 24 hours	proportion of eTICI 2b50/2c/3	24 hours after thrombectomy completed