Scoreflex NC - Scoring PTCA Catheter
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 Scoreflex NC Scoring Percutaneous Transluminal Coronary Angioplasty (PTCA) catheters in subjects with stenotic coronary arteries during percutaneous coronary intervention. Two-hundred (200) subjects will be treated at up to 15 U.S. sites with the Scoreflex NC Scoring PTCA catheter 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
- NCT03763747
- Run by
- OrbusNeich
- People needed
- 200
- Starts
- 2019-02-27
- Expected to finish
- 2019-12-27
- Last updated by the study team
- 2021-08-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- The Cardiac and Vascular Institute Research Foundation — Gainesville, Florida, United States
- University of Miami — Miami, Florida, United States
- Piedmont Heart Institute — Atlanta, Georgia, United States
- Atlanta VA Healthcare System — Decatur, Georgia, United States
- Delmarva Heart Research Foundation Inc./Peninsula Regional Medical Center — Salisbury, Maryland, United States
- CentraCare Heart and Vascular Center — Saint Cloud, Minnesota, United States
- Cardiology Associates Research, LLC — Tupelo, Mississippi, United States
- Deborah Heart and Lung Center — Browns Mills, New Jersey, United States
- The Lindner Research Center/The Christ Hospital Heart and Vascular — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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