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

NCT07368933 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-01-27

No results posted yet for this study

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.

Conditions

  • Angina (Stable)
  • CAD - Coronary Artery Disease
  • Unstable Angina
  • NSTEMI - Non-ST Segment Elevation MI

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

Sponsors & Collaborators

  • Advanced NanoTherapies

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-15
Primary Completion
2027-06-30
Completion
2029-01-31
FDA Device
Yes

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07368933 on ClinicalTrials.gov