NobleStitch EL STITCH Trial is a PFO Comparative Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorNobles Medical Technologies II Inc
About this trial
STITCH - Prospective Multi-Center Comparative Parallel Concurrent Study of the NobleStitch™ EL versus FDA-approved Amplatzer Occluder device for closure of Patent Foramen Ovale to prevent recurrent Ischemic stroke.
Eligibility criteria
Qualifiers
Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Male or female ages 18 - 60 years old
A PFO and a Cryptogenic Stroke verified by a neurologist
Disqualifiers
Female participant who is pregnant, lactating or planning a pregnancy during the course of the study
Age <18 or > 60 years of age
Previous myocardial infarction or unstable angina within 6 months
Clinically significant mitral or aortic valve stenosis or severe regurgitation
Trial design
Treatments tested in this trial
- NobleStitch™EL Suture Mediated Closure System
- Amplatzer PFO Occluder
Treatment groups
640 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov