← Back to Search

Procedure

NobleStitch™EL for Patent Foramen Ovale (STITCH Trial)

N/A
Waitlist Available
Research Sponsored by Nobles Medical Technologies II Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial compares two devices, NobleStitch™ EL and Amplatzer Occluder, for closing a small hole in the heart in patients who have had a stroke. The goal is to see if NobleStitch™ EL is as safe and effective as the Amplatzer Occluder in preventing future strokes. The Amplatzer Occluder has been widely used and studied for closing various heart defects, demonstrating its safety and efficacy.

Eligible Conditions
  • Patent Foramen Ovale
  • Ischemic Stroke

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Effective PFO closure rate of the NobleStitch EL
Secondary study objectives
Decreased event rate of recurrent ischemic stroke following PFO closure using NobleStitch EL
Other study objectives
The occurrence of recurrent ischemic stroke post procedural of patent foramen ovale closure

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: NobleStitch™ELActive Control1 Intervention
Participants treated with the NobleStitch™EL device
Group II: Amplatzer PFO OccluderActive Control1 Intervention
Participants treated with the Amplatzer PFO Occluder device

Find a Location

Who is running the clinical trial?

Nobles Medical Technologies II IncLead Sponsor
1 Previous Clinical Trials
640 Total Patients Enrolled
HeartStitch.ComLead Sponsor
1 Previous Clinical Trials
250 Total Patients Enrolled
Anthony A Nobles, PhDStudy DirectorNobles Medical Technologies II Inc
1 Previous Clinical Trials
640 Total Patients Enrolled

Media Library

Amplatzer PFO Occluder (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04339699 — N/A
Patent Foramen Ovale Research Study Groups: NobleStitch™EL, Amplatzer PFO Occluder
Patent Foramen Ovale Clinical Trial 2023: Amplatzer PFO Occluder Highlights & Side Effects. Trial Name: NCT04339699 — N/A
Amplatzer PFO Occluder (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04339699 — N/A
~225 spots leftby Dec 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top