An observational study in Coronary Artery Stenosis, Coronary Artery Disease and Coronary Balloon, sponsored by TEDA International Cardiovascular Hospital. Completed at 3 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-02.
Sponsored by TEDA International Cardiovascular Hospital · Observational
This multi-center, retrospective study included patients diagnosed with coronary artery stenosis treated with NC PTCA balloons between January 2026 and March 2026 at three real-world centers in central China.
This study is designed as a retrospective, multicenter, real-world study. At three centers, no fewer than 100 consecutive patients with coronary heart disease who were admitted between January 2026 and March 2026, treated with NC PTCA balloon catheters, and had complete case information will be enrolled. The primary endpoints are device success rate and procedure success rate, and the secondary endpoints are major adverse cardiovascular events (MACE), target lesion failure (TLF), all-cause death, and myocardial infarction in-hospital.
302 studies on the registry are indexed under Coronary Stenosis; 63 are open to participants now.
This study's enrollment of 200 is close to the median of 200 across 132 observational studies indexed under Coronary Stenosis.
Browse Coronary Stenosis studies →This is the only study on the registry with TEDA International Cardiovascular Hospital as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Patients with coronary heart disease (CHD) who were treated with at least one NC PTCA balloon dilatation catheter during PCI and had complete case information.
Exclusion Criteria:
The Instructions for Use (IFU) clearly specify contraindications, and patient data with incomplete case information that affects the evaluation of the primary endpoint.
The balloon catheter expands a stenotic portion of the coronary artery or bypass graft during percutaneous transluminal coronary angioplasty (PTCA). The balloon catheter can be used for post-delivery expansion of balloon expandable stents.
Device Success Rate
The balloon successfully reached and crossed the target lesion, was successfully inflated, deflated, and withdrawn back into the guide catheter.
Time frame: immediate post-intervention
Procedural Success Rate
Device success, with no device-related adverse events occurring during the inflation process.
Time frame: immediate post-intervention
Major Adverse Cardiovascular Events (MACE) during hospitalization
A composite of cardiac death, myocardial infarction, or target lesion revascularisation (TLR)
Time frame: during hospitalization, 3-7 days post-procedure
Target Lesion Failure (TLF) during hospitalization
A composite of cardiac death, target vessel myocardial infarction, or clinically-driven target lesion revascularisation (CD-TLR)
Time frame: during hospitalization, 3-7 days post-procedure
All-cause mortality during hospitalization
The proportion of patients who died during the in-hospital until discharge
Time frame: during hospitalization, 3-7 days post-procedure
Any myocardial infarction during hospitalization
The proportion of patients who develop any myocardial infarction during the in-hospital until discharge
Time frame: during hospitalization, 3-7 days post-procedure
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 completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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