NobleStitch EL STITCH Trial is a PFO Comparative Trial

ConditionsForamen Ovale, Patent Stroke, Ischemic

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-60

SponsorNobles Medical Technologies II Inc

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

NobleStitch™EL Suture Mediated Closure System
Device
Percutaneous closure of Patent Foramen Ovale (PFO) using NobleStitch™EL suture Medicate Closure System
Amplatzer PFO Occluder
Device
Percutaneous closure of Patent Foramen Ovale (PFO) using Amplatzer PFO Occluder

Treatment groups

640 Participants

are divided into 2 treatment groups

Group A: NobleStitch™ELActive comparator 1 intervention

Group B: Amplatzer PFO OccluderActive comparator 1 intervention

Trial outcomes

Primary outcomes

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

Time frame

6 months

Secondary outcomes

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

Time frame

5 years

Other outcomes

The occurrence of recurrent ischemic stroke post procedural of patent foramen ovale closure

Examination of Recurrent Ischemic Stroke through 5 year follow up. Comparison of the rate of Stroke associated with the NobleStitch EL procedure to that expected with medical management

Time frame

5 Years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nobles Medical Technologies II Inc

Lead sponsor

Source ClinicalTrials.gov

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