NCT06385067Recruiting
Treatment of Primary Coronary Artery Vascular Lesions With Biolimus Coated Coronary Balloon Dilation Catheter
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
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 400 (estimated)
- First submitted
- 23 Apr 2024
- Start date
- 10 May 2024
- Primary completion date
- 30 Dec 2025
- Lead sponsor
- JW Medical Systems Ltd
- Diseases
- Coronary artery disease
- NCT number
- NCT06385067
What you commit to
- Study type: Observational
- Planned participants: 400
- From 10 May 2024 to the primary completion date, 30 Dec 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First People's Hospital of Lanzhou Coordinator of this site? Confirm its status | Lanzhou | China | Recruiting |
| The First Affiliated Hospital of Guangxi Medical University Coordinator of this site? Confirm its status | Nanning | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.