Sapphire II PRO US Clinical Study
Completed · Not applicable
Conditions studied: Coronary Artery Disease, Coronary Disease, Myocardial Ischemia, Heart Diseases, Arteriosclerosis, Cardiovascular Diseases
In brief
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.
Key facts
- Study ID
- NCT03052530
- Run by
- OrbusNeich
- People needed
- 61
- Starts
- 2017-05-05
- Expected to finish
- 2017-07-24
- Last updated by the study team
- 2018-05-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of Miami — Miami, Florida, United States
- Piedmont Heart Institute — Atlanta, Georgia, United States
- Peninsula Regional Medical Center — Salisbury, Maryland, United States
- The Christ Hospital Heart and Vascular — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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