A Multi-center, Registry evaluating the efficacy and safety of the use of Angionix Balloon in Patient with Coronary Artery Disease
Adult aged 19 years or older at baseline
Patients diagnosed with coronary artery disease
Patients requiring percutaneous transluminal coronary angioplasty (PTCA) with Angionix Balloon or Angionix NC Balloon
Patients who voluntarily agree to participate in this study and sign an informed consent form
Patients presenting with cardiogenic shock based on the investigator's clinical judgment
Patients with vessel dissection already identified on coronary angiography prior to PTCA procedure based on the investigator's clinical judgment
Pregnant or lactating women
Patients who have other clinically significant findings that make them unsuitable for study participation based on the investigator's medical judgment
Adult patients with coronary artery disease who visit participating medical centers and are scheduled to undergo percutaneous transluminal coronary angioplasty (PTCA) using Angionix Balloon or Angionix NC Balloon in routine clinical practice.
Cohort
Prospective
Angionix Balloon
DevicePercutaneous transluminal coronary angioplasty (PTCA) balloon dilatation catheter (Angionix Balloon and Angionix NC Balloon) used for lesion preparation and post-stent dilation in patients with coronary artery disease. Balloon dilatation is performed at nominal pressure or higher for approximately 5 to 10 seconds according to standard clinical procedure.
Successful lesion expansion with Angionix Balloon
Successful lesion expansion is defined as achievement of less than 50% stenosis of the original vessel diameter in the target stenotic lesion treated with Angionix Balloon.
Final procedural success
Final procedural success is defined as successful balloon angioplasty (minimum diameter stenosis \< 30% + final TIMI flow grade 3 without fatal complications during procedure for DCB/POBA) or successful stent implantation (minimum diameter stenosis \< 20% + final TIMI flow grade 3 without fatal complications during procedure).
Incidence of fatal complications during procedure
Occurrence of fatal complications during the procedure, defined as: perforation, cardiac tamponade, emergent operation, intraprocedural stent thrombosis, no reflow / acute closure, distal embolization, side branch occlusion, or stent migration.
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Yonsei University
Lead sponsor
NOBAMEDI CO., LTD.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
