NobleStitch EL versus Amplatzer device for closing a patent foramen ovale after stroke
Official title: 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
Run by Nobles Medical Technologies II Inc · NCT04339699 · Data updated 2026-11-12
This trial will test whether the NobleStitch EL suture closure works as well and is as safe as the Amplatzer occluder for adults 18–60 with a patent foramen ovale who had a cryptogenic ischemic stroke.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 640 (estimated) |
| Sponsor | Nobles Medical Technologies II Inc Industry-sponsored |
| Locations | 2 sites (Tucson, Arizona and 1 other locations) |
| Status | Recruiting |
| Started | January 1, 2021 |
| Main results expected | December 31, 2026 |
| Study ends | June 30, 2027 |
| Registry record updated | March 23, 2026 |
| Trial ID | NCT04339699 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–60 with a confirmed patent foramen ovale and a recent cryptogenic ischemic stroke who meet imaging and prolonged cardiac monitoring requirements and can consent to device closure and follow-up are ideal candidates.
✕Probably not a fit
Patients older than 60, those with a known cause of their stroke (non-cryptogenic), significant extracranial or intracranial atherosclerotic disease, or other contraindications to device closure are unlikely to benefit from this comparison.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, multicenter, parallel-group non-inferiority comparison of the NobleStitch EL suture-mediated closure system versus the FDA-approved Amplatzer PFO occluder, each combined with standard medical management, to prevent recurrent ischemic stroke. Adults aged 18–60 with a PFO and a documented cryptogenic ischemic stroke who meet imaging and prolonged cardiac monitoring requirements are eligible. The trial compares safety and effectiveness endpoints, including recurrent ischemic stroke rates, using concurrent enrollment at multiple sites. The design also references published medical management data to ensure the NobleStitch EL does not increase stroke incidence compared with historical controls.
Why it matters
Potential benefit: If successful, the NobleStitch EL could provide an alternative PFO closure method that avoids leaving a permanent metal implant while offering similar protection against recurrent ischemic stroke.
How similar studies have gone: Randomized trials have shown that occluder devices like Amplatzer reduce recurrent stroke in selected patients, while suture-mediated approaches such as NobleStitch have had smaller and less definitive comparative data.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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 * Left Ventricular Ejection Fraction \<50 percent * Progressive neurological dysfunction or reduced life expectancy * Contrast allergy * Atrial Septal Defect (baseline left to right shunt assessed by TEE or other congenital heart diseases * Active Endocarditis * Perspective participants with known causes of Ischemic Stroke * Arterial dissection * Contraindicated or unsuitable for antiplatelet agents or oral anticoagulants * Perspective participants with prosthetic heart valves * Uncontrolled diabetes Mellitus * Pulmonary hypertension * Uncontrolled systemic hypertension * Intracranial pathology * Neurological deficits not due to stroke that may affect neurologic assessments * Active autoimmune disease * Active infection * Alcohol and/or drug abuse * A requirement for chronic anticoagulation therapy that cannot be discontinued * Anatomic features (inability to achieve vascular access)
Where it's running
-
TMC HealthCare
Tucson, Arizona, United States Recruiting -
Ospedale S. Eugenio
Rome, Lazio, Italy Recruiting
Study contacts
- Study coordinator: James A Thompson, MD
- Email: jthomp80@jhmi.edu
- Phone: 727-767-7328
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.