RECO in the Endovascular Treatment of Acute Ischemic Stroke

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

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

Study Overview

• Status: Recruiting
• Conditions: Intracranial Artery Occlusion With Infarction (Disorder)
• Intervention / Treatment: Device: RECO

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Baixue Jia, PhD,MD; Phone Number: 86-010-67098857; Email: beckyberry@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100010
      • Recruiting
      • Beijing Tiantan Hospital
      • Contact: Zhongrong Miao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with acute ischemic stroke caused by large vessel occlusion and using RECO to receive endovascular treatment.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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]

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in NIHSS score immediately after the procedure	difference between NIHSS score immediately after the procedure and baseline	within 2 hours after the procedure
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
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
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
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
Recanalization rate at the end of the procedure	modified thrombolysis in cerebral infarction (mTICI) 2b-3	Immediately after the procedure
Recanalization rate after the first attempt	mTICI score 2b-3	Immediately after the first attempt of endovascular treatment
Parenchymal hematoma (PH2)	PH2 is defined as the rate of hematoma >30percent in infarct area	12-36 hours after the procedure
Any intracranial hemorrhage on imaging	Based on the image	12-36 hours after the procedure
All-cause mortality within 90 days	mortality	90±7 days after the procedure
Time from onset to arrival	record the time	At baseline, after arrival at the hospital immediately
Time from arrival to imaging	record the time	At baseline, after taking any brain imaging immediately
Time from imaging to puncture	record the time	At baseline, during the procedure, after successful groin puncture immediately
Time from puncture to recanalization	record the time	At baseline, during the procedure, after successful recanalization immediately

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Investigators: Principal Investigator: Zhongrong Miao, PhD,MD, Capital Medical University, Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2020
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): July 30, 2022

Study Registration Dates

• First Submitted: November 6, 2020
• First Submitted That Met QC Criteria: April 8, 2021
• First Posted (Actual): April 12, 2021

Study Record Updates

• Last Update Posted (Actual): April 14, 2021
• Last Update Submitted That Met QC Criteria: April 11, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: endovascular treatment; registry; Acute ischemic stroke
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Infarction; Ischemic Stroke
• Other Study ID Numbers: KY 2019-080-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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