Safety and Efficacy of Cera™ Patent Foramen Ovale Occluders.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorLifetech Scientific (Shenzhen) Co., Ltd.
About this trial
To evaluate the performance of Cera™ patent foramen ovale occluders developed by Lifetech Scientific (Shenzhen) Co., LTD;
Eligibility criteria
Qualifiers
Patients aged 18-60 years;
Be able to understand the purpose of the experiment, voluntarily participate in the experiment and sign the informed consent;
Patent foramen ovale was confirmed by Transthoracic echocardiography (TTE) or Transesophageal echocardiography (TEE);
The presence of medium or large right-to-left shunt was confirmed by Right-heart acoustic contrast (cTTE or cTCD);
Disqualifiers
Carotid atherosclerotic stenosis was determined by the investigator based on CT or vascular ultrasound (> 50%);
Large cerebral infarction occurred within 4 weeks (MR/CT or DWI image ASPECTS score <6 points or infarction volume ≥70 ml or infarction area > 1/3 middle cerebral artery blood supply area);
Patients with intracardiac thrombosis or tumor, intracardiac vegetations;
Acute myocardial infarction or unstable angina within 6 months;
Trial design
Treatments tested in this trial
- Cera™ patent foramen ovale occluders
- Another patent foramen ovale occluders
Treatment groups
244 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov