Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07368933
NA

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

Sponsor: Advanced NanoTherapies

View on ClinicalTrials.gov

Summary

The study objectives are: 1. To evaluate the safety and performance of the SirPlux Duo PTCA to treat coronary ISR lesions 2.00-4.00 mm (inclusive) in diameter in patients with symptomatic coronary artery disease. 2. To evaluate the safety and performance of the SirPlux Duo PTCA to treat coronary de novo lesions \<3.00 mm in diameter in patients with symptomatic coronary artery disease.

Official title: ADVANCEd NanoTherapies SirPlux Duo™ Dual API-Coated PTCA Balloon Catheter to Treat Coronary In-stent Restenosis (ISR) and de Novo Lesions

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2025-12-15

Completion Date

2029-01

Last Updated

2026-01-27

Healthy Volunteers

No

Interventions

DEVICE

SirPlux Duo™ Dual API-Coated PTCA Balloon Catheter

SirPlux Duo PTCA is a Drug-Coated Balloon to treat de novo and In-Stent Restenosis lesions in patients with symptomatic stable angina, unstable angina or NSTEMI

Locations (3)

Hospital Clínic de Barcelona

Barcelona, Spain

Hospital Universitario Marques de Valdecilla

Santander, Spain

Hospital Alvaro Cunqueiro

Vigo, Spain