Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-04-06 @ 9:01 AM
Study NCT ID:
NCT07368933
Status:
RECRUITING
Last Update Posted:
2026-01-27
First Post:
2026-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Advanced NanoTherapies Dual-API DCB to Treat De-Novo and ISR Lesions in Patients With Symptomatic Coronary Artery Disease
Sponsor:
Advanced NanoTherapies
Organization:
Study Overview
Official Title:
ADVANCEd NanoTherapies SirPlux Duo™ Dual API-Coated PTCA Balloon Catheter to Treat Coronary In-stent Restenosis (ISR) and de Novo Lesions
Status:
RECRUITING
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ADVANCE-DUO
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: