Bioresorbable Sirolimus-eluting scaffold in de Novo Coronary Artery Lesions

NANot yet recruitingINTERVENTIONAL
Enrollment

2,000

Participants

Timeline

Start Date

July 1, 2025

Primary Completion Date

July 1, 2030

Study Completion Date

July 1, 2032

Conditions
De Novo StenosisCoronary Artery Disease
Interventions
DEVICE

Sirolimus-eluting bioresorbable scaffolds

The Firesorb BRS (MicroPort Medical, Shanghai, China) is a balloon-expandable scaffold with a highly crystallized PLLA backbone, abluminally coated with a poly(D, L-lactide) (PDLLA) matrix incorporating sirolimus (4 μg/mm) through highly accurate and precise point spraying techniques. The scaffold thickness is 100 μm for devices with diameters of 2.5 and 2.75 mm, and 125 μm for those ranging from 3.0 to 4.0 mm in diameter. There are two radiopaque markers at each end of the scaffold, which can identify the position of the stent under X-ray monitoring and help to accurately locate the scaffold.

DEVICE

Sirolimus-eluting stents

The Firehawk™ stent (MicroPort Medical, Shanghai, China) is a third-generation balloon-expandable L605 cobalt chromium stent with abluminal grooves containing a biodegradable polymer, which provides controlled release of the anti-proliferative medicinal substance sirolimus. The polymer is biodegradable, leaving only the metallic stent as a permanent implant. The stent is mounted on a rapid exchange delivery catheter system. The unique abluminal grooves are scored at the outer surface of the struts (total strut thickness: 86 μm), with an average sirolimus dosage of 3 µg/mm stent lengths.

Trial Locations (1)

710032

Xijing Hospital, Xi'an

All Listed Sponsors
lead

Xijing Hospital

OTHER

NCT07022587 - Bioresorbable Sirolimus-eluting scaffold in de Novo Coronary Artery Lesions | Biotech Hunter | Biotech Hunter