Sapphire 3 CTO Study
Completed · Not applicable
Conditions studied: Coronary Artery Disease, Coronary Disease, Myocardial Ischemia, Heart Diseases, Arteriosclerosis, Cardiovascular Diseases, Chronic Total Occlusion, Chronic Total Occlusion of Coronary Artery
In brief
A prospective, open label, multi-center, single arm, observational study designed to evaluate the acute safety and device performance of the Sapphire 3 0.85, 1.0 and 1.25mm diameter coronary dilatation catheter in predilatation of Chronic Total Occlusion (CTO) lesions during percutaneous coronary intervention. One hundred seventy (170) subjects will be enrolled with a target of one hundred fifty-three (153) evaluable subjects by the angiographic core laboratory at up to 15 clinical sites with the Sapphire 3 0.85, 1.0 and 1.25mm diameter PTCA dilatation catheter to pre-dilate CTO lesions in coronary arteries during their index procedure. All subjects will be screened according to the protocol inclusion and exclusion criteria and will be followed through study completion, which is defined as 24-hours post-procedure or hospital discharge, whichever comes first.
Key facts
- Study ID
- NCT06358508
- Run by
- OrbusNeich
- People needed
- 170
- Starts
- 2024-11-06
- Expected to finish
- 2025-10-21
- Last updated by the study team
- 2026-01-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Stanford Health Care — Stanford, California, United States
- Torrance Memorial Medical Center — Torrance, California, United States
- Emory University Hospital Midtown — Atlanta, Georgia, United States
- Piedmont Heart Institute — Atlanta, Georgia, United States
- Emory University Hospital — Atlanta, Georgia, United States
- Emory St. Joseph's Hospital — Atlanta, Georgia, United States
- Atlanta VA Health Care System — Decatur, Georgia, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Brigham and Women's Hospital Heart and Vascular Center — Boston, Massachusetts, United States
- Henry Ford Health System — Detroit, Michigan, United States
- Minneapolis Heart Institute Foundation — Minneapolis, Minnesota, United States
- University of Washington — Seattle, Washington, United States
- Hospital Universitari de Bellvitge — Barcelona, Spain
- Hospital Clinico Universitario de Valladolid — Valladolid, Spain
Full record on ClinicalTrials.gov
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