A Study on the 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

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2600117013

Enrollment

Unknown

Registered

2026-01-19

Start date

2024-06-19

Completion date

Unknown

Last updated

2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary coronary artery disease with a blood vessel diameter of 2.0mm-2.75mm

Interventions

Biolimus coated Coronary Artery Balloon Dilation Catheter (BioAscend) Treatment Group:NA

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age>=18 years old; 2. Primary coronary artery stenosis with a blood vessel diameter between 2.0mm and 2.75mm; 3. Patients with residual stenosis<=30% after preprocessing and<=B-type dissection; 4. Patients who voluntarily participate and sign an informed consent form, and are willing to undergo follow-up according to the protocol requirements.

Exclusion criteria

Exclusion criteria: 1. Pregnant or breastfeeding women; 2. Patients with cardiogenic shock; 3. Patients with severe congestive heart failure or NYHA IV grade severe heart failure; Patients with severe valvular heart disease; 4. Patients with an expected life expectancy of no more than 24 months or factors that cause difficulties in clinical follow-up; 5. For other reasons, researchers believe that patients are not suitable for inclusion; 6. Known to be allergic to amoxicillin and contrast agents.

Design outcomes

Primary

Measure	Time frame
Target lesion failure rate;	—

Secondary

Measure	Time frame
intervention success rate;Major adverse cardiac events (MACE);device-related cardiovascular clinical composite endpoints, including cardiac death, target-vessel myocardial infarction, and clinically symptom-driven revascularization of the target lesion (excludin;Incidence of thrombotic events as defined by the ARC (acute, subacute, and late time identified, probable, and non-excludable thrombi during the time period);Patient-related cardiovascular clinical composite endpoints, including all-cause mortality, all myocardial infarctions, and any revascularization (excluding elective interventions);	—

Measure

Time frame

intervention success rate;Major adverse cardiac events (MACE);device-related cardiovascular clinical composite endpoints, including cardiac death, target-vessel myocardial infarction, and clinically symptom-driven revascularization of the target lesion (excludin;Incidence of thrombotic events as defined by the ARC (acute, subacute, and late time identified, probable, and non-excludable thrombi during the time period);Patient-related cardiovascular clinical composite endpoints, including all-cause mortality, all myocardial infarctions, and any revascularization (excluding elective interventions);

—

Countries

China

Contacts

Public ContactLi Lang

The First Affiliated Hospital of Guangxi Medical University

drlilang@163.com+86 771 533 1171

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026