Biolimus-coated balloon catheter for narrowed coronary arteries in real-world use
Studies a drug-coated balloon catheter in adults with narrowed heart arteries.
Plain-language title generated from the registry record
Registry title: Treatment of Primary Coronary Artery Vascular Lesions With Biolimus Coated Coronary Balloon Dilation Catheter
Key facts
- Where
- Lanzhou and Nanning, ChinaSee the 2 sites
Where in China
- The First People's Hospital of LanzhouLanzhou, ChinaTaking people
- The First Affiliated Hospital of Guangxi Medical UniversityNanning, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- JW Medical Systems Ltd
- Trial code
- NCT06385067
- Record updated
- 27 October 2026
- Original description
The purpose of the study was to further evaluate the long-term safety and efficacy of the Biolimus Coated Coronary Artery Balloon Dilation Catheter in the real world.Read full original descriptionShow less
Prospective, International Multicenter Clinical Study Evaluating the Safety and Efficacy of the Biolimus Coated Coronary Artery Balloon Dilation Catheter (BioAscend) in the Treatment of Primary Coronary Artery Disease in the Real World
The purpose of the study was to further evaluate the long-term safety and efficacy of the Biolimus Coated Coronary Artery Balloon Dilation Catheter in the real world.
The study population was patients with primary coronary vascular lesions with a blood vessel diameter of 2.0mm-2.75mm.
Inclusion: Age ≥ 18 years; Primary coronary artery stenosis with a vessel diameter of 2.0 mm to 2.75 mm; Patients with residual stenosis of ≤ 30 percent after pretreatment and ≤ type B dissection; Patients who voluntarily participate in and sign the informed consent form, and who are willing to undergo follow-up as required by the protocol.
Exclusion: Patients with severe congestive heart failure or severe heart failure with NYHA class IV; Patients with severe valvular heart disease; Those who are known to be allergic to melcrolimus and contrast media; Pregnant or lactating females; Patients with cardiogenic shock; Patients with a life expectancy of less than 24 months or factors that make clinical follow-up difficult; Patients who are considered unsuitable for inclusion by the investigator for other reasons.