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Taking people in ItalyNo phase

Compares two devices closing a heart hole to prevent repeat stroke

Compares two devices for closing a heart hole in adults with prior ischemic stroke.

Key facts

Who runs it
Nobles Medical Technologies II Inc
Where
Rome, ItalySee the siteAlso in 1 other country, 1 site
Trial code
Registry title
NobleStitch EL STITCH Trial is a PFO Comparative Trial
Status
Recruiting
People taking part
640 people, planned
Started
1 Jan 2021
Expected to end
30 Jun 2027
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • NobleStitch™EL Suture Mediated Closure System
  • Amplatzer PFO Occluder
Record updated
23 March 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18 to 60 who had a stroke with no known cause and who have a patent foramen ovale (PFO), a small opening in the heart. It compares two PFO closure devices.

Age
18 to 60 years old
Sex
Men and women can join.
Disease stage
A PFO and a stroke of unknown cause (cryptogenic stroke), confirmed by a neurologist. The stroke caused sudden nerve problems lasting 24 hours or more, or shorter with a new injury seen on MRI or CT.

Main reasons for not taking part

  • Pregnant, breastfeeding or planning a pregnancy during the study
  • Heart attack or unstable angina within the last 6 months
  • Left ventricular ejection fraction below 50 percent
  • Stroke with a known cause, such as arterial dissection
  • Cannot take antiplatelet drugs or oral anticoagulants

The registry criteria, word for word

Show all 32 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Previous myocardial infarction or unstable angina within 6 months
  • Alcohol and/or drug abuse
  • A requirement for chronic anticoagulation therapy that cannot be discontinued
  • 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
  • Left Ventricular Ejection Fraction <50 percent
  • Age <18 or > 60 years of age
  • 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)

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 60 years old?

Where in Italy

Also in 1 other country, 1 site

  • Ospedale S. EugenioRome, ItalyContact: Tarsia Carmela, MDTaking people

About the trial

What the trial wants 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.

The 2 groups in the trial

  • NobleStitch™ELExisting treatment, for comparison

    Participants treated with the NobleStitch™EL device

    Treatment: NobleStitch™EL Suture Mediated Closure System

  • Amplatzer PFO OccluderExisting treatment, for comparison

    Participants treated with the Amplatzer PFO Occluder device

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Plain-language title
Compares two devices closing a heart hole to prevent repeat strokeGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT04339699, who can take part
Record updated
23 March 2026