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NCT04339699 · ClinicalTrials.gov registry record · NA
NobleStitch EL STITCH Trial is a PFO Comparative Trial
A NA study of Stroke, Ischemic and Foramen Ovale, Patent, sponsored by Nobles Medical Technologies II.
- Recruiting
- Registry status
- NA
- Development phase
- 640
- Enrollment target
- 2
- Study locations
NCT04339699: Recruiting NA study of Stroke, Ischemic and Foramen Ovale, Patent, sponsored by Nobles Medical Technologies II.
NCT04339699 is a NA study of Stroke, Ischemic and Foramen Ovale, Patent that is actively recruiting participants, run by Nobles Medical Technologies II. The registered enrollment target is 640 participants, above the 270-participant average among 33 other Stroke, Ischemic trials with a reported enrollment target (137% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04339699, a NA study of Stroke, Ischemic and Foramen Ovale, Patent, is actively recruiting participants, sponsored by Nobles Medical Technologies II.
- RECRUITING
- Registry status
- NA
- Development phase
- 640 participants
- Enrollment target
- 2
- Study locations
Study Summary
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.
Primary Outcome
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
Conditions Studied
Interventions
- DEVICE NobleStitch™EL Suture Mediated Closure System
- DEVICE Amplatzer PFO Occluder
Study Locations (2)
Arizona
- TMC HealthCare - Tucson
Lazio
- Ospedale S. Eugenio - Rome
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 640 participants |
| Start Date | 2021-01-01 |
| Est. Completion | 2027-06-30 |
| Phase | NA |
What NCT04339699 shows while recruiting
NCT04339699 is an interventional study that assigns participants to a tested intervention. The registered 640 participants enrollment target is mid-sized for trials with a published cap, above the 270-participant average among 33 other Stroke, Ischemic trials with a reported enrollment target (137% higher).
The record links to 2 conditions, with Stroke, Ischemic appearing as the primary indexed condition, and to 2 interventions - of which NobleStitch™EL Suture Mediated Closure System is the first listed.
NCT04339699 reports a single indexed study location in Arizona, Lazio.
Frequently Asked Questions
What is clinical trial NCT04339699 about?
NCT04339699 is a clinical study titled "NobleStitch EL STITCH Trial is a PFO Comparative 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.
What is the current status of trial NCT04339699?
This trial is currently recruiting. It is a NA study. The enrollment target is 640 participants. The study started on 2021-01-01. Estimated completion is 2027-06-30.
What conditions does trial NCT04339699 study?
This clinical trial studies the following conditions: Stroke, Ischemic, Foramen Ovale, Patent.
What interventions are being tested in trial NCT04339699?
The interventions under investigation include: NobleStitch™EL Suture Mediated Closure System (DEVICE), Amplatzer PFO Occluder (DEVICE).
Who is sponsoring clinical trial NCT04339699?
This trial is sponsored by Nobles Medical Technologies II, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04339699 being conducted?
This trial has 2 study locations across Arizona, Lazio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stroke, Ischemic
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04339699's enrollment target sits among peer trials
640 4th of 33 higher than 30 of 33 other Stroke, Ischemic trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stroke, Ischemic trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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