NCT05521542

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Advanced NanoTherapies · Industry
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The SirPlux Duo™ Dual API-Coated PTCA Balloon Catheter is an investigational medical device to be used to treat de-novo lesions in patients with symptomatic stable angina, unstable angina, and NSTEMI. In this study, SirPlux Duo™ will be used in subjects undergoing a planned percutaneous coronary intervention. The population to treat will include those with de-novo coronary lesions in vessels with a reference vessel diameter (RVD) of ≥2.0 and ≤4.0 mm and a total lesion length of \<36mm with documented symptomatic stable angina, unstable angina, or NSTEMI. The study is a prospective, single-arm, multi-center, safety and feasibility first-in-human study designed to generate descriptive data about the use of SirPlux Duo™.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	SirPlux Duo™ Dual-API Coated PTCA Balloon Catheter	SirPlux Duo™ Dual-API Coated PTCA Balloon Catheter is a Drug-Coated Balloon to treat de novo lesions in patients with symptomatic stable angina, unstable angina, or NSTEMI

Timeline

• Start date: 2023-01-30
• Primary completion: 2025-12-31
• Completion: 2027-03-01
• First posted: 2022-08-30
• Last updated: 2025-10-03

Locations

5 sites across 3 countries: Australia, Dominican Republic, New Zealand

Regulatory

• FDA-regulated device study