Endovascular Thrombectomy in COVID-19 Infected Patients

Ischemic Stroke Clinical Trial

— ET-COVID-19  

Official title:

Endovascular Thrombectomy in COVID-19 Infected Patients: Intrahospital and Peri-operative Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04406090
• Other study ID #: RECHMPL20_0322
• Status: Completed
• Start date: April 1, 2020
• Est. completion date: June 30, 2020

Study information

• Verified date: May 2020
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

About 5% of COVID-19 patients may present symptoms related to acute ischemic stroke (AIS). Treatment-management and outcomes related to mechanical thrombectomy (MT) for COVID-19 infected patients harboring large vessel occlusion is largely unknown.

This multicentric study aims to investigate morbidity, mortality and neurological outcomes after MT performed in patients with COVID-19 infection.

Description:

Since the identification of the first case of Severe Acute Respiratory Syndrome (SARS) CoV-2 infection in December 2019 in Wuhan, China, the global number of confirmed COVID-19 cases is roughly 5 000 000, with 216 involved countries. Increasing evidence shows that SARS-CoV-2 may be associated with neurological manifestations, with up to 36% of patients showing neurological symptoms related to the neurovirulence of the SARS-CoV-2.

It has been reported that roughly 5% of COVID-19 infected patients may present acute ischemic stroke (AIS), and these patients may have an unfavorable clinical evolution due to the systemic involvement of the infective disease. In addition, these patients are quite young: the mean age of COVID-19 patients having AIS is lower (56 years), compared to general population of AIS patients (mean age=73 years). Moreover, most of these patients require an intensive care units (ICU) management. Stroke mechanisms may be multiple and can include hypercoagulability from critical illness, cardioembolism from virus-related cardiac injury, and severe inflammation. Indeed, the dysfunction of endothelial cells induced by infection may promote an increased thrombin generation and fibrinolysis; moreover, the hypoxia found in severe COVID-19 patients can be a trigger for thrombosis, increasing blood viscosity, and inducing hypoxia-inducible transcription factors.

Outcomes related to the treatment of COVID-19 patients harboring large vessel occlusion and requiring MT is substantially unknown, but it is likely that the combined morbidity and mortality rate of the two pathologies is high. Accordingly, patient's selection, treatment-management, and results should be urgently elucidated.

Involving 4 different countries (France, Italy, Spain, and US), this multicentric cohort study aims to analyze the largest possible number of COVID-19 infected patients treated with MT for AIS, with the intention to provide treatment-results and neurological outcomes, elucidating the best patient-selection and treatment-management.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Patients >18 years infected with the SARR-CoV-2 with acute ischemic stroke, and eligible for mechanical thrombectomy (based on the current guide-lines)

Exclusion criteria:

• Patients <18 years ; no eligibility to mechanical thrombectomy ; absence of diagnosis of COVID-19

Related Conditions & MeSH terms

• Covid 19
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Other:
• Mechanical Trombectomy
Stent retriever for treatment of cerebral arterial occlusions

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intrahospital mortality	Intrahospital mortality after MT for COVID-19 infected patients harboring large vessel occlusion	1day
Primary	short-term morbidity	short-term morbidity after MT for COVID-19 infected patients harboring large vessel occlusion	1 day
Secondary	Angiographic success	Angiographic success after MT for COVID-19 infected patients harboring large vessel occlusion	1 day