Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03052530 · ClinicalTrials.gov registry record · NA
Sapphire II PRO US Clinical Study
A NA study, sponsored by OrbusNeich.
- Completed
- Registry status
- NA
- Development phase
- 61
- Enrollment target
NCT03052530 is a NA study that has completed, run by OrbusNeich. The registered enrollment target is 61 participants.
The verdict
NCT03052530, a NA study, has completed, sponsored by OrbusNeich.
- COMPLETED
- Registry status
- NA
- Development phase
- 61 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 Sapphire II PRO 1.0 and 1.25 mm PTCA dilatation catheters in subjects with stenotic coronary arteries or bypass grafts during percutaneous coronary intervention. Sixty (60) subjects will be treated at up to 5 U.S. sites with the Sapphire II PRO diameters 1.0 and 1.25 mm PTCA dilatation catheters to pre-dilate coronary arteries or bypass grafts during their index procedure. All subjects will be screened according to the protocol inclusion and exclusion criteria and will be followed through hospital discharge.
Interventions
- DEVICE Sapphire II PRO
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2017-05-05 |
| Est. Completion | 2017-07-24 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03052530
The ClinicalTrials.gov registry entry for NCT03052530 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 61 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is OrbusNeich, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Sapphire II PRO is the first listed.
NCT03052530 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03052530 about?
NCT03052530 is a clinical study titled "Sapphire II PRO US Clinical Study". A prospective, open label, multi-center, single arm, observational study designed to evaluate the acute safety and device procedural success of the Sapphire II PRO 1.0 and 1.25 mm PTCA dilatation catheters in subjects with stenotic coronary arteries or bypass grafts during percutaneous coronary inte...
What is the current status of trial NCT03052530?
This trial is currently completed. It is a NA study. The enrollment target is 61 participants. The study started on 2017-05-05. Estimated completion is 2017-07-24.
What interventions are being tested in trial NCT03052530?
The interventions under investigation include: Sapphire II PRO (DEVICE).
Who is sponsoring clinical trial NCT03052530?
This trial is sponsored by OrbusNeich, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.