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: Completed NA study, sponsored by OrbusNeich.
NCT03052530 is a NA study that has completed, run by OrbusNeich. The registered enrollment target is 61 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
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 TIMI flow from baseline related to the study balloon * Final TIMI flow grade of 3 at the conclusion of the PCI procedure
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 |
What the finished NCT03052530 record still lists
NCT03052530 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Sapphire II PRO is the first listed.
NCT03052530 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT03052530's enrollment target sits among peer trials
61 1164th of 2000 higher than 837 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04115306 · 61 participants · Phase 1
Phase 1/1b/2 Study of Oral PMD-026 in Patients With Metastatic Breast Cancer
- NCT05070845 · 61 participants · Phase 2
Safety and Efficacy Study of PF-06835375 in Primary Immune Thrombocytopenia
- NCT05187832 · 61 participants · Phase 1
A Study of AND019 in Women With ER Positive HER2 Negative Advanced or Metastatic Breast Cancer
- NCT05269316 · 61 participants · Phase 1
Study to Evaluate IMP9064 as a Monotherapy or in Combination in Patients With Advanced Solid Tumors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI