Status:
RECRUITING
Russian Registry of Endovascular Closure of PFO
Lead Sponsor:
National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
Conditions:
Patent Foramen Ovale
Eligibility:
All Genders
18-70 years
Brief Summary
The study will include all patients over 18 years of age who underwent endovascular closure of patent foramen ovale in medical centers in the Russian Federation, who gave written informed consent to t...
Detailed Description
Ischemic stroke is the fifth most common cause of death and the leading cause of disability among adult patients worldwide. Cryptogenic stroke is a very broad term that applies in cases of incomplete ...
Eligibility Criteria
Inclusion
- Patients with an ischemic event (cryptogenic ischemic stroke, transient ischemic attack, embolism of other organs and systems) associated with a PFO;
- Presence of an open oval confirmed by ultrasound diagnostic methods;
- Age of patients from 18 years;
- Life expectancy of at least 1 year;
- Signed informed consent for endovascular closure of a PFO.
Exclusion
- Inability to receive antiplatelet therapy;
- Presence of acute inflammatory diseases;
- Acute stage of cerebral circulatory failure (30 days);
- Myocardial infarction or aortocoronary bypass surgery within the previous 30 days;
- Carotid or vertebral artery dissection;
- Severe cardiac valve pathology;
- Presence of blood clots in the cardiac cavities;
- Refusal of the patient to participate in the study.
Key Trial Info
Start Date :
December 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT06156670
Start Date
December 1 2023
End Date
December 31 2025
Last Update
January 29 2025
Active Locations (1)
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1
National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
Moscow, Russia