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

NCT06385067 | Not Yet Recruiting

• 1 other identifier: JW-PM-DCB-2024
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Interventional success rate

  Immediately after operation

• Device-related cardiovascular clinical composite endpoint

  From postoperative to before discharge, day 30, month 6, month 12, month 24

• Patient-related cardiovascular clinical composite endpoint

  From postoperative to before discharge, day 30, month 6, month 12, month 24

• Major adverse cardiac events (MACEs)

  From postoperative to before discharge, day 30, month 6, month 12, month 24

• Incidence of thrombotic events as defined by ARC

  From postoperative to before discharge, day 30, month 6, month 12, month 24

Study Arms (1)

Experimental group

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.

Device: Biolimus Coated Coronary Artery Balloon Dilation Catheter

Interventions

Biolimus Coated Coronary Artery Balloon Dilation Catheter DEVICE

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

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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;

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Those who are known to be allergic to melcrolimus and contrast media.

Sponsors & Collaborators

• JW Medical Systems Ltd: lead

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Lang Li

  First Affiliated Hospital of Guangxi Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuanchun Sun

CONTACT

13683382463; sunyuanchun@bluesail.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: April 25, 2024
• Study Start: May 10, 2024
• Primary Completion: December 30, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: April 25, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share