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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06385067
• Other study ID #: JW-PM-DCB-2024
• Status: Not yet recruiting
• Start date: May 10, 2024
• Est. completion date: December 30, 2026

Study information

• Verified date: April 2024
• Source: JW Medical Systems Ltd
• Contact: Yuanchun Sun
• Phone: 13683382463
• Email: sunyuanchun[@]bluesail.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: December 30, 2026
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Biolimus Coated Coronary Artery Balloon Dilation Catheter
Patients with Coronary Artery Disease will be treated with Biolimus Coated Coronary Artery Balloon Dilation Catheter

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
JW Medical Systems Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target lesion failure rate (TLF)	Target lesion failure rate (TLF) at 12 months after surgery, including cardiogenic death, target vascular myocardial infarction, and clinically symptom-driven target lesion revascularization (CD-TLR)	12 months after surgery
Secondary	Interventional success rate	Including device success rate, pathogenic power and clinical success rate	Immediately after operation
Secondary	Device-related cardiovascular clinical composite endpoint	Device-related cardiovascular clinical composite endpoints from postoperative to pre-discharge, day 30, month 6, month 12, and month 24, including cardiac death, target vessel myocardial infarction, and clinically symptom-driven target lesion revascularization (excluding elective interventional therapy)Device-related cardiovascular clinical composite endpoints from postoperative to pre-discharge, day 30, month 6, month 12, and month 24, including cardiac death, target vessel myocardial infarction, and clinically symptom-driven target lesion revascularization (excluding elective interventional therapy)	From postoperative to before discharge, day 30, month 6, month 12, month 24
Secondary	Patient-related cardiovascular clinical composite endpoint	Patient-related cardiovascular clinical composite endpoints including all-cause mortality, all myocardial infarction, and any revascularization (excluding elective interventional therapy) from postoperative to pre-discharge, day 30, month 6, month 12, and month 24	From postoperative to before discharge, day 30, month 6, month 12, month 24
Secondary	Major adverse cardiac events (MACEs)	Including cardiac death, myocardial infarction, and target lesion revascularization (TLR) at postoperative to pre-discharge, day 30, month 6, month 12, and month 24.	From postoperative to before discharge, day 30, month 6, month 12, month 24
Secondary	Incidence of thrombotic events as defined by ARC	Including identified, probable, and unexcluded thrombosis in the acute, subacute, and late periods acute, subacute, and late Defined, probable, and non-excluded thrombosis within the segment	From postoperative to before discharge, day 30, month 6, month 12, month 24