NCT04339699 NobleStitch EL STITCH Trial is a PFO Comparative Trial
| NCT ID | NCT04339699 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nobles Medical Technologies II Inc |
| Condition | Foramen Ovale, Patent |
| Study Type | INTERVENTIONAL |
| Enrollment | 640 participants |
| Start Date | 2021-01-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 640 participants in total. It began in 2021-01-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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)
Contact & Investigator
Anthony A Nobles, PhD
STUDY DIRECTOR
Nobles Medical Technologies II Inc
Frequently Asked Questions
Who can join the NCT04339699 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Foramen Ovale, Patent. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04339699 currently recruiting?
Yes, NCT04339699 is actively recruiting participants. Contact the research team at jthomp80@jhmi.edu for enrollment information.
Where is the NCT04339699 trial being conducted?
This trial is being conducted at Tucson, United States, Rome, Italy.
Who is sponsoring the NCT04339699 clinical trial?
NCT04339699 is sponsored by Nobles Medical Technologies II Inc. The principal investigator is Anthony A Nobles, PhD at Nobles Medical Technologies II Inc. The trial plans to enroll 640 participants.