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New treatment option for Foramen Ovale, Patent
Official title NobleStitch EL STITCH Trial is a PFO Comparative Trial
ClinicalTrials.gov ID: NCT04339699
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- 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:
You likely can't join if
- Female participant who is pregnant, lactating or planning a pregnancy during the course of the study
- Age \ 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
See the full eligibility 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...
- Hypercoagulable state assessment to rule out an underlying hypercoagulable state
- Female participant who is pregnant, lactating or planning a pregnancy during the course of the study
- Age \ 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)
The study team makes the final eligibility decision.
Where it's taking place
- Tucson, Arizona, United States
- Rome, Lazio, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tucson, Arizona, United States; Rome, Lazio, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.