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

Not yet recruiting

• Conditions: Coronary Artery Disease
• Interventions: Device: Biolimus Coated Coronary Artery Balloon Dilation Catheter

• Registration Number: NCT06385067
• Lead Sponsor: JW Medical Systems Ltd

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-23
• Study First Submitted QC: 2024-04-23
• Last Update Submitted: 2024-04-23
• Study First Posted: 2024-04-25
• Last Update Posted: 2024-04-25
• Study Start: 2024-05-10
• Primary Completion: 2025-12-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental group	Biolimus Coated Coronary Artery Balloon Dilation Catheter	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.

Primary Outcome Measures

Name	Time	Method
Target lesion failure rate (TLF)	12 months after surgery	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)

Secondary Outcome Measures

Name	Time	Method
Incidence of thrombotic events as defined by ARC	From postoperative to before discharge, day 30, month 6, month 12, month 24	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
Interventional success rate	Immediately after operation	Including device success rate, pathogenic power and clinical success rate
Major adverse cardiac events (MACEs)	From postoperative to before discharge, day 30, month 6, month 12, month 24	Including cardiac death, myocardial infarction, and target lesion revascularization (TLR) at postoperative to pre-discharge, day 30, month 6, month 12, and month 24.
Device-related cardiovascular clinical composite endpoint	From postoperative to before discharge, day 30, month 6, month 12, month 24	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)
Patient-related cardiovascular clinical composite endpoint	From postoperative to before discharge, day 30, month 6, month 12, month 24	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