๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-09-30

Advanced NanoTherapies Dual-API DCB to Treat De-Novo Lesions in Patients With Symptomatic Coronary Artery Disease (NCT05521542)

ADVANCEd NanoTherapies Dual Active Pharmacological Ingredient (Dual-API) Drug-Coated Balloon Catheter to Treat De-Novo Lesions in Patients With Symptomatic Stable Angina, Unstable Angina, and NSTEMI

๐Ÿ”ต Active, Not Recruiting Observational / Diagnostic โš™๏ธ Medical Device Protocol Sponsor: Advanced NanoTherapies

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

This prospective, single-arm, multi-center, safety and feasibility first-in-human study will evaluate the safety and feasibility of the SirPlux Duoโ„ข Dual-API Coated PTCA Balloon Catheter to treat de-novo lesions between โ‰ฅ2.0 and โ‰ค4.0 mm in patients with symptomatic stable angina, unstable angina, and NSTEMI.

Who can join: Review the eligibility criteria below.

Location: The Prince Charles Hospital โ€” Chermside, Queensland

Age range: 18 Years to 89 Years

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (5 Sites)

  • The Prince Charles Hospital โ€” Chermside, Queensland
  • Royal Adelaide Hospital โ€” Adelaide, South Australia
  • Victorian Heart Institute - Monash University โ€” Clayton, Victoria
  • Cecanot Hospital โ€” Santo Domingo,
  • Te Toka Tumai Auckland, Auckland City Hospital โ€” Auckland,

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—