Clinical Trial

Advanced NanoTherapies Dual-API DCB to Treat De-Novo Lesions in Patients With Symptomatic Coronary Artery Disease

Study acronym: ADVANCE-DCB
Active, Not Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated October 3, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
Summary
This prospective, single-arm, multi-center, safety and feasibility first-in-human study will evaluate the safety and feasibility of the SirPlux Duo™ Dual-API Coated PTCA Balloon Catheter to treat de-novo lesions between ≥2.0 and ≤4.0 mm in patients with symptomatic stable angina, unstable angina, and NSTEMI.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2022-08-26; most recent amendment 2025-09-30.
Status change: Recruiting → Active, Not Recruiting 2025-09-30
Status change: Withheld → Recruiting 2023-02-02
Trial Details
NCT Number NCT05521542
Lead Sponsor Advanced NanoTherapies
Collaborators: Monash University, Cardiovascular Research Foundation, New York
Conditions Coronary Artery Disease
Enrollment 28 participants
Start Date 2023-01-30
Primary Completion 2025-12-31 (estimated)
Study Completion 2027-03 (estimated)
Updated on ClinicalTrials.gov 2025-10-03