Actively Recruiting
NobleStitch EL STITCH Trial is a PFO Comparative Trial
Led by Nobles Medical Technologies II Inc · Updated on 2026-03-23
640
Participants Needed
2
Research Sites
338 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
NobleStitch EL STITCH Trial is a PFO Comparative Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Willingness to comply with all study procedures and availability for the study duration
- Male or female aged 18 to 60 years old
- Diagnosed Patent Foramen Ovale (PFO) and cryptogenic stroke verified by a neurologist
- Stroke defined as an acute focal neurological deficit with symptoms lasting 24 hours or more, or symptoms less than 24 hours with MRI or CT showing a new relevant infarct
- Cryptogenic stroke defined as stroke of unknown cause
- Prolonged cardiac rhythm monitoring of at least 24 hours (recommended 30 days)
- Intra and extracranial artery imaging to rule out stroke related to other vascular diseases
- Assessment to exclude hypercoagulable state
You will not qualify if you...
- Female participants who are pregnant, lactating, or planning pregnancy during the study
- Age under 18 or over 60 years
- Previous myocardial infarction or unstable angina within 6 months
- Significant mitral or aortic valve stenosis or severe regurgitation
- Left ventricular ejection fraction less than 50 percent
- Progressive neurological dysfunction or reduced life expectancy
- Allergy to contrast agents
- Atrial septal defect or other congenital heart diseases
- Active endocarditis
- Known causes of ischemic stroke other than cryptogenic
- Arterial dissection
- Contraindication or unsuitability for antiplatelet or oral anticoagulant therapy
- Prosthetic heart valves
- Uncontrolled diabetes mellitus
- Pulmonary hypertension
- Uncontrolled systemic hypertension
- Intracranial pathology
- Neurological deficits unrelated to stroke that affect assessments
- Active autoimmune disease
- Active infection
- Alcohol or drug abuse
- Need for chronic anticoagulation therapy that cannot be stopped
- Anatomic features preventing vascular access
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
TMC HealthCare
Tucson, Arizona, United States, 85712
Actively Recruiting
2
Ospedale S. Eugenio
Rome, Lazio, Italy, 00144
Actively Recruiting
Research Team
J
James A Thompson, MD
CONTACT
A
Anthony Nobles, Phd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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