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

Study acronym: ADVANCE-DCB
StatusActive, Not Recruiting
PhaseNot applicable
Started
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.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date: Dec 31, 2024 to Dec 31, 2025
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 40 to confirmed 28
    • Site details revised at 5 of 5 sites
    v5
  2. Primary completion date: Oct 2023 to Dec 31, 2024v4 Show 9 more changesShow less
    • Primary endpoints revised (4)
    • Study sites: 3 to 5
    • Study completion date: Apr 2025 to Mar 2027
    • Interventions: SirPlux™ Duo Dual-API Coated PTCA Balloon Catheter (Device) to SirPlux Duo™ Dual-API Coated PTCA Balloon Catheter (Device)
    • Secondary endpoints: 8 to 13
    • Study description shortened, about 54 words
    • Collaborators: 3 to 2
    • Study title shortened, about 6 words
    • Eligibility criteria expanded, about 3 words
  3. Lead sponsor: [Redacted] to Advanced NanoTherapiesv3 Show 6 more changesShow less
    • Trial status: Withheld to Recruiting
    • Primary completion date: Oct 2023
    • Study completion date: Apr 2025
    • Start date: Jan 30, 2023
    • Collaborators expanded, about 10 words
    • Study title expanded, about 8 words
  4. Re-verified, no change to tracked fieldsv2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05521542
Lead Sponsor Advanced NanoTherapies
Collaborators: Monash University, Cardiovascular Research Foundation, New York
Conditions
(from sponsor)		 Coronary Artery Disease
Related terms Coronary Artery Disease
Enrollment 28 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov