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.
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At a Glance
Age
18 – 60
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
640 (estimated)
Sponsor
Nobles Medical Technologies II Inc · Industry
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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