NobleStitch EL for Patent Foramen Ovale and Stroke

NobleStitch EL STITCH Trial is a PFO Comparative Trial

Recruiting N/A Interventional Study
Foramen Ovale, Patent Stroke, Ischemic
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.

Are You a Good Fit for This Trial?
Rules you out Significant heart valve problemsUncontrolled diabetes MellitusPulmonary hypertensionUncontrolled systemic hypertensionActive infectionsActive autoimmune disease

You may be able to join if

  • I am between 18 and 60 years old
  • I have been diagnosed with a Patent Foramen Ovale
  • I have had a stroke with no known cause
  • I can provide signed consent to participate
  • I am willing to follow study procedures
  • 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.

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About This Trial

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…
Contacts

James A Thompson, MD

727-767-7328

jthomp80@jhmi.edu

CONTACT

Anthony Nobles, Phd

714-427-0398

anobles@noblesmed2.com

CONTACT