A Retrospective Study of Reco Thrombectomy Stent for Intravascular Treatment of Acute Ischemic Stroke

Neurology Clinical Trial

Official title:

A Retrospective Study of Reco Thrombectomy Stent for Intravascular Treatment of Acute Ischemic Stroke

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05166733
• Other study ID #: 2021(ke)CL274
• Status: Not yet recruiting
• Start date: December 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: December 2021
• Source: The First People's Hospital of Changzhou
• Contact: Jie Cao
• Phone: 13646125766
• Email: mayday509[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To explore the differences in the green channel process of stroke in various regions of the same province, to target and shorten the time delay of emergency process, and to explore the key technologies of endovascular treatment of acute ischemic stroke. To investigate the use and embolectomy effect of Reco, the first embolectomy stent in China, in economically developed areas. Health economic assessment (cost-benefit analysis) of ischemic stroke patients in various regions of the province.

Description:

The Reco Embolectomy Stent is indicated for patients who cannot be treated with intravenous tissue activator (IVt-PA) or who have failed IVt-PA therapy and is intended to remove thrombus from a large intracranial vessel in patients with ischemic stroke to restore blood flow.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient age =18 years

• The clinical diagnosis was acute ischemic stroke

• Large vascular lesions were detected by head CT, CTA, MRI, MRA or DSA

• Preoperative baseline NIHSS score > 4

• MRS 0-1 before this stroke

• Mechanical thrombectomy was performed

• Use Reco thrombectomy bracket

Exclusion Criteria:

• epileptic seizure

• Sudden coma

• Neurological loss symptoms quickly improved

• Imaging was negative, but clinical symptoms did not rule out subarachnoid hemorrhage

• Previous intracranial hemorrhage, subarachnoid hemorrhage, and brain tumor (with mass effect)

• History of head trauma within 3 months prior to surgery

• History of arterial puncture with difficulty in compression and hemostasis within one week prior to surgery

• Physical examination revealed evidence of active bleeding or trauma (e.g. fracture)

• Women are known to be pregnant or breastfeeding

• Severe allergies to contrast agents are known

Related Conditions & MeSH terms

• Ischemic Stroke
• Neurology

Locations

Country	Name	City	State
China	The First People's Hospital of Changzhou	Changzhou	Jiangsu

Sponsors (6)

Lead Sponsor	Collaborator
PengYa	Jingjiang People's Hospital, Northern Jiangsu Province People's Hospital, The Affiliated Hospital of Xuzhou Medical University, The Second Hospital of Nanjing Medical University, Yixing People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The time between the onset of the disease and the opening of the blood vessels	Calculate the time from onset to vessel opening	Immediately after surgery
Primary	Functional independence at 90 days (defined as mRS=2)	mRS scores were performed 90 days after surgery	90day after surgery
Primary	Symptomatic intracranial hemorrhage within 24 hours after surgery	Symptomatic intracranial hemorrhage was evaluated by CT 24 hours after operation	24 hours after surgery
Secondary	Time from onset to admission	Calculate the time from onset to admission	Immediately after surgery
Secondary	Time from admission and puncture time	Calculate the time from onset to admission	Immediately after surgery
Secondary	Puncture to the time of vessel opening	Calculate the time from puncture to vascular opening	Immediately after surgery