An observational study in Coronary Artery Disease, sponsored by Yonsei University. Not yet recruiting at 3 sites in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Yonsei University · Observational
A Multi-center, Registry evaluating the efficacy and safety of the use of Angionix Balloon in Patient with Coronary Artery Disease
This study is designed to evaluate the safety and efficacy of the Angionix Balloon-a domestically developed coronary balloon dilatation catheter-when used in percutaneous coronary angioplasty (PTCA) for patients with coronary artery disease.
The main objectives are to assess procedural success rates, vessel expansion success, and the occurrence of major complications during real-world clinical use in lesion preparation and stent post-dilation.
5,676 studies on the registry are indexed under Coronary Artery Disease; 958 are open to participants now.
This study's planned enrollment of 600 is above the median of 335 across 1,978 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Yonsei University is the lead sponsor of 1,410 studies on the registry; 235 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Adult patients aged 19 years or older with coronary artery disease who require percutaneous transluminal coronary angioplasty (PTCA) using Angionix Balloon or Angionix NC Balloon.
Device: Angionix Balloon
Percutaneous 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.
Time frame: During the procedure (immediately after balloon dilatation)
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).
Time frame: At the end of the PTCA 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.
Time frame: Periprocedural
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Mar 2028, 15 months later.
Of 726 non-industry observational studies under Coronary Artery Disease, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 122. This study's planned 15 months is below that.
Counting every sponsor, half of 857 studies reached it within 43 months; a quarter within 22 and three quarters within 88.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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