Clinical trial NCT05166733: A Retrospective Study of Reco Thrombectomy Stent for Intravascular Treatment of Acute Ischemic Stroke
Official title: A Retrospective Study of Reco Thrombectomy Stent for Intravascular Treatment of Acute Ischemic Stroke
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neurology
Interventional Therapy
Keywords: ischemic stroke
Reco
endovascular treatment
Lead sponsor: The First People's Hospital of Changzhou
Sponsor class: OTHER
Collaborators: name: Jingjiang People's Hospital
name: The Affiliated Hospital of Xuzhou Medical University
name: The Second Hospital of Nanjing Medical University
name: Northern Jiangsu People's Hospital
name: Yixing People's Hospital
First posted: 2021-12-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing endovascular treatment for acute ischemic stroke with the Reco Embolectomy Stent from December 2018 to June 2021.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The time between the onset of the disease and the opening of the blood vessels
timeFrame: Immediately after surgery
measure: Functional independence at 90 days (defined as mRS≤2)
timeFrame: 90day after surgery
measure: Symptomatic intracranial hemorrhage within 24 hours after surgery
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Time from onset to admission
timeFrame: Immediately after surgery
measure: Time from admission and puncture time
timeFrame: Immediately after surgery
measure: Puncture to the time of vessel opening
timeFrame: Immediately after surgery
Other outcomes:
Locations:
city: Changzhou
country: China
facility: The First People's Hospital of Changzhou
state: Jiangsu
Study officials:
References: