RECO in the Endovascular Treatment of Acute Ischemic Stroke

Intracranial Artery Occlusion With Infarction (Disorder) Clinical Trial

Official title:

A Prospective ,Multicenter, Registry Study of RECO in the Endovascular Treatment of Acute Ischemic Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04840719
• Other study ID #: KY 2019-080-03
• Status: Recruiting
• Start date: May 22, 2020
• Est. completion date: July 30, 2022

Study information

• Verified date: April 2021
• Source: Beijing Tiantan Hospital
• Contact: Baixue Jia, PhD,MD
• Phone: 86-010-67098857
• Email: beckyberry[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Investigate Reco ® ,the first clot retriever in china as the primary therapyand remedies in the real world.

Description:

Endovascular thrombectomy (EVT) is effective and safe for acute ischemic stroke (AIS) caused by large vessel occlusion (LVO) in major clinical trials. Whether the benefit of EVT in randomized trials could be generalized to clinical practice, especially in developing countries, remains unknown. The Registry was established to evaluate the utilization, and subsequent outcomes of EVT treated AIS patients. This study is a multi-center, prospective registry study initiated by researchers, to investigate Reco ® ,the first clot retriever in china as the primary therapyand remedies in the real world.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: July 30, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age = 18 years old

2. Diagnosis of acute ischemic stroke

3. Imaging confirmed intracranial large artery occlusion (LVO): intracranial internal carotid artery (ICA T/L), middle cerebral artery (MCA M1/M2), anterior cerebral artery (ACA A1/A2), basilar artery (BA), vertebral artery (VA V4), and posterior cerebral artery (PCA P1);ASPECT or PC-ASPECT = 6

4. Initiation of any type of endovascular treatment (EVT), including intra-arterial thrombolysis, mechanical thrombectomy, angioplasty, and stenting

5. The patient or the patient's legal representative is able and willing to sign the informed consent

Exclusion Criteria:

1. Isolated cervical ICA or VA occlusion;

2. No evidence of LVO on DSA.

Related Conditions & MeSH terms

• Infarction
• Intracranial Artery Occlusion With Infarction (Disorder)

Intervention

Device:
• RECO

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional independence at 90 days (modified Rankin Scale of 0-2)	The range of modified Rankin Scale was from 0 to 6. 0-No symptoms;1-No significant disability;2-Slight disability;3-Moderate disability;4-Moderately severe disability;5-Severe disability;6 -Dead.A higher score indicates worse a outcome.	[90±7 days after procedure]
Primary	Symptomatic intracranial hemorrhage (sICH) within 12-36 hours after the procedure	Heidelberg Bleeding Classification): new intracranial hemorrhage detected by brain imaging associated with =4 points total National Institutes of Health Stroke Scale (NIHSS), =2 points in one NIHSS category, leading to intubation/ hemicraniectomy/ EVD placement or other major medical/surgical intervention, or absence of alternative explanation for deterioration	12-36 hours after the procedure
Primary	Time from symptom onset to recanalization	Minutes	From the time of symptom onset until the time of of the recanalization of the occluded artery, assessed up to 48 hours
Secondary	Recanalization rate at the end of the procedure	modified thrombolysis in cerebral infarction (mTICI) 2b-3	Immediately after the procedure
Secondary	Recanalization rate after the first attempt	mTICI score 2b-3	Immediately after the first attempt of endovascular treatment
Secondary	Changes in NIHSS score immediately after the procedure	difference between NIHSS score immediately after the procedure and baseline	within 2 hours after the procedure
Secondary	Changes in NIHSS score 24 hours after the procedure	difference between NIHSS score 24 hours after the procedure and baseline	24 hours after the procedure
Secondary	Changes in NIHSS score 7 days after the procedure or at discharge	difference between NIHSS score 7 days after the procedure or discharge and baseline	7 days after the procedure or discharge
Secondary	EQ-5D 90 days after the procedure	EQ-5D is a standardized instrument for measuring generic health status. Rated level can be coded as a number 1, 2, or 3, which indicates having no problems for 1, having some problems for 2, and having extreme problems for 3. As a result, a person's health status can be defined by a 5-digit number, ranging from 11111 (having no problems in all dimensions) to 33333 (having extreme problems in all dimensions).A higher score indicates a better outcome.	90±7 days after the procedure
Secondary	Barthel index (BI) 90 days after the procedure	The BI has a score of 0-100. A higher score indicates a better outcome.	90±7 days after the procedure
Secondary	Parenchymal hematoma (PH2)	PH2 is defined as the rate of hematoma >30percent in infarct area	12-36 hours after the procedure
Secondary	Any intracranial hemorrhage on imaging	Based on the image	12-36 hours after the procedure
Secondary	All-cause mortality within 90 days	mortality	90±7 days after the procedure
Secondary	Time from onset to arrival	record the time	At baseline, after arrival at the hospital immediately
Secondary	Time from arrival to imaging	record the time	At baseline, after taking any brain imaging immediately
Secondary	Time from imaging to puncture	record the time	At baseline, during the procedure, after successful groin puncture immediately
Secondary	Time from puncture to recanalization	record the time	At baseline, during the procedure, after successful recanalization immediately