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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
STITCH Trial Summary
This trial will compare the effectiveness of two devices for closing a PFO to reduce the risk of recurrent stroke.
Eligible Conditions
- Ischemic Stroke
- Patent Foramen Ovale
STITCH Trial 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
STITCH 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is a person such as myself eligible to join this clinical investigation?
"This medical trial is targeting 640 patients between 18 and 60 years of age who have a patent foramen ovale."
Answered by AI
Does this medical experiment permit individuals who are beyond the age of 35 to take part?
"This research project is open to participants of legal age or older, and under the age of sixty."
Answered by AI
What is the aggregate figure of participants in this research project?
"Affirmative, the online records from clinicaltrials.gov confirm that this experiment is currently recruiting volunteers. This project was initially publicized on December 1st 2020 and has been amended as of April 20th 2021. 640 participants are being sought out at one medical facility."
Answered by AI
Is there an active recruitment stage in this trial?
"Affirmative. The information posted on clinicaltrials.gov demonstrates that this medical experiment is currently recruiting subjects, which was initially announced December 1st 2020 and last revised April 20th 2021. 640 participants are needed to be recruited from a single clinic site."
Answered by AI
Who else is applying?
What state do they live in?
Alabama
Louisiana
Pennsylvania
How old are they?
18 - 65
What site did they apply to?
Inova Cardiovascular Institute
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
Why did patients apply to this trial?
What questions have other patients asked about this trial?
How soon is this trial starting in? What all does it involve?
PatientReceived 2+ prior treatments
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