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

NCT07582250 | Not Yet Recruiting DMC

• 1 other identifier: JWBA9DES-202601
• Study Type: interventional
• Target: 1,548
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Patients With de Novo Coronary Artery Lesions

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

experimental group

EXPERIMENTAL

Biolimus-Coated Coronary Balloon Dilatation Catheter

Device: Biolimus-Coated Coronary Artery Balloon Dilatation Catheter

Control Group

ACTIVE COMPARATOR

Xinyue Drug-Coated Stent System

Device: Xinyue Drug-Coated Stent System

Interventions

Xinyue Drug-Coated Stent System DEVICE

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.

Control Group

Biolimus-Coated Coronary Artery Balloon Dilatation Catheter DEVICE

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.

experimental group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged ≥ 18 years and ≤ 80 years;
• Patients with stable angina, unstable angina, old myocardial infarction, or asymptomatic myocardial ischemia with objective evidence;
• Patients without contraindications to coronary revascularization (PCI or CABG);
• 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.
• 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).
• 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%.
• Each target lesion is only allowed to be treated with one investigational device or control device (except for bailout stent implantation).
• 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.

Sponsors & Collaborators

• JW Medical Systems Ltd: lead

Study Officials

• Bin Liu

  Second Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wang Yang Project Manager

CONTACT

13366024088; yang.wang@jwmsgrp.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 12, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2030
• Last Updated: May 12, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share