Compares two devices closing a heart hole to prevent repeat stroke
Compares two devices for closing a heart hole in adults with prior ischemic stroke.
Plain-language title generated from the registry record
Registry title: NobleStitch EL STITCH Trial is a PFO Comparative Trial
Key facts
- Where
- Rome, ItalySee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 60 years old?
Source: NCT04339699, who can take part
Where in Italy
- Ospedale S. EugenioRome, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Nobles Medical Technologies II Inc
- Trial code
- NCT04339699
- Record updated
- 23 March 2026
- Original description
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.Read full original descriptionShow less
STITCH - Prospective Multi Center Comparative Parallel Concurrent Study of the NobleStitch EL Compared to FDA Approved Amplatzer Occluder Device for Closure of Patent Foramen Ovale to Prevent Recurrent Ischemic Stroke
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.
Inclusion: 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; Stroke is defined as an acute focal neurological deficit, presumed to be due to focal ischemia, and either:; Symptoms persisting ≥24 hours, or; Symptoms persisting <24 hours with Magnetic Resonance or CT findings of a new, neuroanatomical relevant infarct; Cryptogenic stroke was defined as a stroke of unknown cause; Prolonged cardiac rhythm monitoring (recommended 30 days and not less than 24 hours required); Intra and extracranial artery imaging: Magnetic Resonance Angiography, CT angiography, or contrast angiography, or contrast angiography or echocardiography of the carotid arteries to rule out ischemic stroke associated with atherosclerotic plaque, arterial dissection, or other vascular diseases. (The aortic arch may also be evaluated by TEE); Hypercoagulable state assessment to rule out an underlying hypercoagulable state.
Exclusion: Previous myocardial infarction or unstable angina within 6 months; Alcohol and/or drug abuse; A requirement for chronic anticoagulation therapy that cannot be discontinued; Contrast allergy; Atrial Septal Defect (baseline left to right shunt assessed by TEE or other congenital heart diseases; Perspective participants with known causes of Ischemic Stroke; Perspective participants with prosthetic heart valves; Uncontrolled diabetes Mellitus; Pulmonary hypertension; Uncontrolled systemic hypertension; Neurological deficits not due to stroke that may affect neurologic assessments; Active autoimmune disease; Active infection; Left Ventricular Ejection Fraction <50 percent; Age <18 or > 60 years of age; Female participant who is pregnant, lactating or planning a pregnancy during the course of the study; Clinically significant mitral or aortic valve stenosis or severe regurgitation; Progressive neurological dysfunction or reduced life expectancy; Active Endocarditis; Arterial dissection; Contraindicated or unsuitable for antiplatelet agents or oral anticoagulants; Intracranial pathology; Anatomic features (inability to achieve vascular access).