To evaluate the acute safety and device procedural success of the Emerge 1.20 mm PTCA dilatation catheter when used as a pre-dilatation device in the stenotic portion of coronary arteries or bypass grafts.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
The Emerge 1.20 mm device is the next-generation Boston Scientific PTCA dilatation catheter. It is a sterile, single-use, intravascular medical device used to improve lumen diameter. The catheter consists of a shaft with a balloon near the distal tip. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures.
Piedmont Heart Institute
Atlanta, Georgia, United States
Device Procedural Success
Device procedural success consisting of the following: 1. Successful delivery, inflation, deflation and withdrawal of the study balloon. 2. No evidence of vessel perforation, flow limiting dissection (grade C or higher) or reduction in TIMI flow from baseline related to the study balloon. 3. Final TIMI flow grade of 3 at the conclusion of the percutaneous coronary intervention procedure
Time frame: Peri-procedural
In-hospital Major Adverse Cardiac Events (MACE)
In-hospital MACE: 1. All death (cardiac and non-cardiac) 2. Myocardial infarction (MI) 3. Target Vessel Revascularization (TVR) 4. In-hospital Stent Thrombosis (ST) within the target vessel 5. Clinically significant arrhythmias (requiring intervention)
Time frame: Participants will be followed for the duration of hospital stay (an expected average of 24 hours)
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