18 and older, any sex, with Coronary Artery Disease or Coronary Disease. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Device Procedural SuccessPrimary· Peri-procedural (at Day 0)
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
Group
Value
95% CI
Sapphire II PRO
59
Number of Participants With In-hospital Major Adverse Cardiac Events (MACE)Secondary· Endpoints will be measured through hospital discharge (expected to be within 24 hours)
In-hospital Major Adverse Cardiac Events (MACE)
* All death (cardiac and non-cardiac)
* Myocardial infarction (MI)
* Target Lesion Revascularization (TLR)
Group
Value
95% CI
Sapphire II PRO
1
Number of Participants With In-hospital Stent Thrombosis (ST) Within the Target VesselSecondary· Endpoint will be measured through hospital discharge (expected to be within 24 hours)
In-hospital stent thrombosis (ST) within the target vessel
Group
Value
95% CI
Sapphire II PRO
0
Number of Participants With Clinically Significant Arrhythmias (Requiring Intervention)Secondary· Endpoint will be measured through hospital discharge (expected to be within 24 hours)
Time frame: Per the protocol, adverse events were collected from the point of subject enrollment through study completion at hospital discharge (hospital stay expected to be an average of 24 hours)..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by OrbusNeich
Last refreshed: 11 May 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03052530.