NCT04339699Recruiting
NobleStitch EL STITCH Trial is a PFO Comparative Trial
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
Source: ClinicalTrials.gov · Last updated 23 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 640 (estimated)
- First submitted
- 1 Apr 2020
- Start date
- 1 Jan 2021
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Nobles Medical Technologies II Inc
- Diseases
- Stroke
- NCT number
- NCT04339699
What you commit to
- Study type: Interventional
- Planned participants: 640
- From 1 Jan 2021 to the primary completion date, 31 Dec 2026
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous myocardial infarction or unstable angina within 6 months
- Alcohol and/or drug abuse
- A requirement for chronic anticoagulation therapy that cannot be discontinued
Other illness
- 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
Lab values
- Left Ventricular Ejection Fraction \<50 percent
Age
- Age \<18 or \> 60 years of age
Other
- 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)
Who the study is looking for
- 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
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ospedale S. Eugenio Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| TMC Healthcare Coordinator of this site? Confirm its status | Tucson | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.