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NCT03763747 · ClinicalTrials.gov registry record · NA
Scoreflex NC - Scoring PTCA Catheter
A NA study, sponsored by OrbusNeich.
- Completed
- Registry status
- NA
- Development phase
- 200
- Enrollment target
NCT03763747: Completed NA study, sponsored by OrbusNeich.
NCT03763747 is a NA study that has completed, run by OrbusNeich. The registered enrollment target is 200 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03763747, a NA study, has completed, sponsored by OrbusNeich.
- COMPLETED
- Registry status
- NA
- Development phase
- 200 participants
- Enrollment target
Study Summary
A prospective, open label, multi-center, single arm, observational study designed to evaluate the acute safety and device procedural success of the Scoreflex NC Scoring Percutaneous Transluminal Coronary Angioplasty (PTCA) catheters in subjects with stenotic coronary arteries during percutaneous coronary intervention. Two-hundred (200) subjects will be treated at up to 15 U.S. sites with the Scoreflex NC Scoring PTCA catheter during their index procedure. All subjects will be screened according to the protocol inclusion and exclusion criteria and will be followed through hospital discharge.
Primary Outcome
Device procedural success consisting of the following: * Successful delivery, inflation, deflation, and withdrawal of the study balloon * No evidence of vessel perforation, flow limiting dissection (grade C or higher) or reduction in Thrombolysis In Myocardial Infarction (TIMI) flow from baseline as related to the Scoreflex NC study balloon * Final TIMI flow grade of 3 at the conclusion of the percutaneous coronary intervention (PCI) procedure
Interventions
- DEVICE Scoreflex NC Scoring PTCA catheter
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2019-02-27 |
| Est. Completion | 2019-12-27 |
| Phase | NA |
What the finished NCT03763747 record still lists
NCT03763747 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 1 intervention - of which Scoreflex NC Scoring PTCA catheter is the first listed.
NCT03763747 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03763747 about?
NCT03763747 is a clinical study titled "Scoreflex NC - Scoring PTCA Catheter". A prospective, open label, multi-center, single arm, observational study designed to evaluate the acute safety and device procedural success of the Scoreflex NC Scoring Percutaneous Transluminal Coronary Angioplasty (PTCA) catheters in subjects with stenotic coronary arteries during percutaneous cor...
What is the current status of trial NCT03763747?
This trial is currently completed. It is a NA study. The enrollment target is 200 participants. The study started on 2019-02-27. Estimated completion is 2019-12-27.
What interventions are being tested in trial NCT03763747?
The interventions under investigation include: Scoreflex NC Scoring PTCA catheter (DEVICE).
Who is sponsoring clinical trial NCT03763747?
This trial is sponsored by OrbusNeich, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03763747's enrollment target sits among peer trials
200 506th of 2000 higher than 1,434 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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