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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
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
- Ischemic Stroke
- Patent Foramen Ovale
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Effective PFO closure rate of the NobleStitch EL
Secondary outcome measures
Decreased event rate of recurrent ischemic stroke following PFO closure using NobleStitch EL
Other outcome measures
The occurrence of recurrent ischemic stroke post procedural of patent foramen ovale closure
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
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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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Cryptogenic stroke means that the cause of your stroke is unknown.You have a negative pregnancy test at the time of screening if you are male or female ages 18 - 60 years old.You have a prolonged cardiac rhythm monitoring (recommended 30 days and not less than 24 hours required).You are willing to comply with all study procedures and are available for the duration of the study.
Research Study Groups:
This trial has the following groups:- Group 1: NobleStitch™EL
- Group 2: Amplatzer PFO Occluder
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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