Treatment of Primary Coronary Artery Vascular Lesions With Biolimus Coated Coronary Balloon Dilation Catheter

JW Medical Systems

Status: Not yet enrolling

Conditions: Coronary Artery Disease

Treatments: Device: Biolimus Coated Coronary Artery Balloon Dilation Catheter

Study type: Observational

Funder types: Industry

Identifiers

NCT06385067

JW-PM-DCB-2024

Details and patient eligibility

About

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.

Full description

Study Design:

1. Prospective, international multi-center clinical study;
2. It is planned to recruit 300 subjects in China and a total of 100 subjects in Indonesia and Thailand who meet the criteria for study inclusion to use at least one Biolimus coated coronary balloon dilation catheter (BioAscend) to treat primary in situ coronary artery vascular disease with a diameter of 2.0mm-2.75mm regardless of the number of blood vessels, the length and number of treated lesions;
3. In the study, subgroups of long lesions, bifurcation lesions, and acute myocardial infarction were set up, and subjects who met the definition were directly entered into the subgroup analysis.
4. Register and collect data using the EDC system;
5. Enrollment method: competitive enrollment;
6. Follow-up time points: postoperative to before discharge, 30 days, 6 months, 12 months, and 24 months.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• Pregnant or lactating females;
• Patients with cardiogenic shock;
• Patients with severe congestive heart failure or severe heart failure with NYHA class IV;
• Patients with severe valvular heart disease;
• 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.
• Those who are known to be allergic to melcrolimus and contrast media.

Trial design

400 participants in 1 patient group

Experimental group

Description:

Use at least one Biolimus coated coronary balloon dilation catheter (BioAscend) to treat primary in situ coronary artery vascular disease with a diameter of 2.0 mm-2.75 mm regardless of the number of blood vessels, the length and number of treated lesions.

Treatment:

Device: Biolimus Coated Coronary Artery Balloon Dilation Catheter