The purpose of this study is to collect data from real-world use with the Glider Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter to support the effectiveness of the Glider PTCA Balloon for crossing into complex coronary lesions.
Observational Study collecting data on commercial cases in which the Glider PTCA Balloon Catheter is used in accordance with the instructions for use. This study includes up 500 patients at up to 50 study sites.
Study Type
OBSERVATIONAL
Enrollment
100
Alexian Brothers Heart and Vascualr Institute
Elk Grove Village, Illinois, United States
Washington University in St. Louis
St Louis, Missouri, United States
York Hospital
York, Pennsylvania, United States
Cardiovascular Specialists of Texas
Austin, Texas, United States
Technical Success Rate
Percentage of lesions successfully crossed among those attempted with the Glider PTCA catheter.
Time frame: 1 hour
Freedom from Balloon Slippage
Percentage of inflations with the Glider balloon in which the physician user reports no slippage.
Time frame: 1 hour
Lesion Success Rate
Percentage of lesions with \<50% diameter stenosis, or Thrombolysis In Myocardial Infarction (TIMI) 3 flow if side branch is present, without development of MACE during hospital stay.
Time frame: 48 hours
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