No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 60
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
640 (estimated)
Sponsor
Nobles Medical Technologies II Inc · Industry
Who this trial is looking for
This trial is looking for adults with a specific type of heart condition and a stroke that does not have a known cause. Participants will undergo evaluations and may receive a device to help prevent future strokes.
I have undergone heart monitoring for at least 24 hours
I have had imaging of my arteries
I have been assessed for a hypercoagulable state
You may not be able to join if
I am pregnant, breastfeeding, or planning to become pregnant
I am younger than 18 or older than 60
I have had a heart attack or unstable angina in the past 6 months
I have significant heart valve problems
I have a low heart function percentage
I have other health issues that affect my life expectancy
I have allergies to contrast material used in imaging
I have a history of drug or alcohol abuse
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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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…
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)
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