A Prospective, Multicenter, Randomized Controlled Clinical Study on the Safety and Efficacy of Biolimus Drug-Coated Balloon (DCB) Versus Drug-Eluting Stent (DES) in the Treatment of De Novo Coronary Artery Lesions

To compare the safety and efficacy of Biolimus drug-coated balloon (DCB) versus drug-eluting stent (DES) in the treatment of de novo coronary artery lesions.

Study Overview

• Status: Not yet recruiting
• Conditions: Patients With de Novo Coronary Artery Lesions
• Intervention / Treatment: Device: Biolimus-Coated Coronary Artery Balloon Dilatation Catheter; Device: Xinyue Drug-Coated Stent System

• Study Type: Interventional
• Enrollment (Estimated): 1548
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wang Yang Project Manager; Phone Number: 13366024088; Email: yang.wang@jwmsgrp.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

General Inclusion Criteria:

1. Patients aged ≥ 18 years and ≤ 80 years;
2. Patients with stable angina, unstable angina, old myocardial infarction, or asymptomatic myocardial ischemia with objective evidence;
3. Patients without contraindications to coronary revascularization (PCI or CABG);
4. Patients who can understand the study purpose, voluntarily participate in the trial, sign the informed consent form, and are willing to complete follow-up as required by the protocol.

Angiographic Inclusion Criteria:

1. The target lesions are de novo native coronary artery lesions, located in 1 or 2 different coronary arteries; the number of target lesions in each coronary artery shall not exceed 1 (for two-vessel disease, a maximum of 2 target lesions are permitted).

2. All target lesions shall meet the following requirements:

   ① The reference vessel diameter is between 2.25 mm and 4.0 mm, and the lesion length ≤ 30 mm;

   ② The visual estimated stenosis degree before procedure ≥ 70%, or ≥ 50% with documented ischemic evidence;

   ③ Successful pre-dilation: defined as no NHLBI type C or higher dissection; TIMI flow grade 3; residual stenosis ≤ 30%.

3. Each target lesion is only allowed to be treated with one investigational device or control device (except for bailout stent implantation).
4. If the patient has non-target lesions requiring concurrent intervention, such non-target lesions shall be successfully treated prior to the treatment of target lesions.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental group; Biolimus-Coated Coronary Balloon Dilatation Catheter	Device: Biolimus-Coated Coronary Artery Balloon Dilatation Catheter; A total of 774 subjects meeting the inclusion and exclusion criteria were enrolled and assigned to the treatment group of Biolimus-Coated Coronary Artery Balloon Dilatation Catheter.
Active Comparator: Control Group; Xinyue Drug-Coated Stent System	Device: Xinyue Drug-Coated Stent System; A total of 774 eligible subjects who met the inclusion and exclusion criteria were enrolled and assigned to the treatment group of Excrossal™ Xinyue Drug-Coated Stent System.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary endpoint	The primary endpoint of target lesion failure (TLF) at 1 year post-operation was defined as a composite of cardiac death, target vessel myocardial infarction (TV-MI), or clinically driven target lesion revascularization (CD-TLR).	Day of procedure (treatment day), 7 days post-procedure or discharge day, 30 days post-procedure, 6 months post-procedure, 9 months post-procedure, and 1 year post-procedure.

Collaborators and Investigators

• Sponsor: JW Medical Systems Ltd
• Investigators: Principal Investigator: Bin Liu, Second Hospital of Jilin University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: May 6, 2026
• First Submitted That Met QC Criteria: May 6, 2026
• First Posted (Actual): May 12, 2026

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: JWBA9DES-202601

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No