Foramen Ovale, PatentSTITCHNCT04339699
NobleStitch EL STITCH Trial is a PFO Comparative Trial
A study testing NobleStitch™EL Suture Mediated Closure System and Amplatzer PFO Occluder in people with Foramen Ovale, Patent and Stroke, Ischemic, run by Nobles Medical Technologies II Inc at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Foramen Ovale, Patent, Stroke, Ischemic
- What is being tested?
- NobleStitch™EL Suture Mediated Closure System and Amplatzer PFO Occluder
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 640 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Jan 2021to 30 Jun 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
TMC HealthCare
Tucson, Arizona, 85712
Natalia E Calles, MPH, 520-324-5512, natalia.eliascalles@tmcaz.com
Thomas Waggoner, MD
Italy1 site, 1 recruiting
- Recruiting
Ospedale S. Eugenio
Rome, Lazio, 00144
Tarsia Carmela, MD, +390651002864, tarsiacarmen@gmail.com
Achille Gaspardone, MD, +390651002864, achille.gaspardone@aslroma2.it
About this study
Official title: 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
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.
Read the detailed description
To demonstrate the non-inferiority of the NobleStitch™ EL with medical management in both safety and effectiveness compared to the FDA-approved Amplatzer Occluder with medical management for PFO Closure.
To demonstrate that the NobleStitch EL does not increase the incidence of ischemic stroke compared to published medical management data.
- Conditions
- Foramen Ovale, Patent, Stroke, Ischemic
- Being tested
- NobleStitch™EL Suture Mediated Closure System, Amplatzer PFO Occluder
- Keywords
- Patent Foramen Ovale, Stroke
- Medical subject headings
- Foramen Ovale, Patent, Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NobleStitch™EL Suture Mediated Closure SystemDevice
Percutaneous closure of Patent Foramen Ovale (PFO) using NobleStitch™EL suture Medicate Closure System
Amplatzer PFO OccluderDevice
Percutaneous closure of Patent Foramen Ovale (PFO) using Amplatzer PFO Occluder
| Study group | Role | What they receive |
|---|---|---|
| NobleStitch™EL | Active comparator | Participants treated with the NobleStitch™EL device Receives: Device: NobleStitch™EL Suture Mediated Closure System |
| Amplatzer PFO Occluder | Active comparator | Participants treated with the Amplatzer PFO Occluder device Receives: Device: Amplatzer PFO Occluder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective PFO closure rate of the NobleStitch EL
Effectiveness PFO closure rate of NobleStitch EL suture mediated closure with medical management compared to Amplatzer PFO occluder with medical management for PFO closure. Effective PFO closure rate defined as Grade 0 or 1 shunt at rest and during Valsalva at 6 month post closure attempts
Measured: 6 months
Secondary outcomes (1)
Decreased event rate of recurrent ischemic stroke following PFO closure using NobleStitch EL
Safety of NobleStitch EL suture mediated closure system as compared to Amplatzer PFO Occluder Procedural and device related adverse event rate at 6 month follow up recurrent ischemic stroke through 5 years follow up
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2020
- Study start1 Jan 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Foramen Ovale, PatentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A 640 participants indicated for percutaneous transcatheter closure of a PFO to reduce risk of recurrent Ischemic Stroke; between ages 18 - 60 years, who have had a Cryptogenic Stroke due to Paradoxical Embolism. To be conducted both in the USA and the European Union.
- Masking
- None (open label)
- Enrolment
- 640 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nobles Medical Technologies II Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anthony A Nobles, PhD, Study director, Nobles Medical Technologies II Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04339699
- Sponsor's protocol ID
- 748824-0819
- Acronym
- STITCH
- Status last verified
- Mar 2026
- First submitted
- 1 Apr 2020
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data (IPD) from the completed STITCH clinical trial that underlie the results reported in the Study, shall after deidentification (text, tables, figures, and appendices).
Publications
Gaspardone A, De Marco F, Sgueglia GA, De Santis A, Iamele M, D'Ascoli E, Tusa M, Corciu A, Mullen M, Nobles A, Carminati M, Bedogni F. Novel percutaneous suture-mediated patent foramen ovale closure technique: early results of the NobleStitch EL Italian Registry. EuroIntervention. 2018 Jun 8;14(3):e272-e279. doi: 10.4244/EIJ-D-18-00023.
PubMed 29616629