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.
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