Bioresorbable Sirolimus-eluting scaffold in de Novo Coronary Artery Lesions

Summary

Bioresorbable scaffold (BRS) was designed aiming to avoid the late adverse events associated with permanent metallic stents by providing temporary support to the vessel wall and promoting vessel remodeling, plaque reduction, and restoring vasomotion after its full absorption. As the first FDA-approved BRS, ABSORB BRS was associated with a significantly higher risk of late scaffold thrombosis compared with everolimus-eluting stent (EES). As a result, the ESC-EAPCI task force recommended that the current ABSORB BRS should not be preferred over conventional DES in clinical practice. To solve this dilemma, improved scaffold technology and optimal implantation techniques are necessary.

The latest generation Firesorb BRS is a PLLA backbone scaffold system abluminally coated with poly(D, L-lactide) mixed with sirolimus using highly accurate and precise point spraying techniques. Compared to the ABSORB BRS, Firesorb features a thinner stent thickness (100-125 μm) while maintaining sufficient radial support, enabling faster degradation and a shorter duration of presence in the coronary. Additionally, inspired by the design of the Firehawk DES, its unique spot-coating process applies a single-sided coating layer exclusively to the stent's outer surface, enabling targeted drug release. Preclinical trials have demonstrated favorable performance for Firesorb, culminating in its approval by the National Medical Products Administration (NMPA) in 2024.

Against these backgrounds, we have designed this trial to investigate whether the Firesorb BRS is non-inferior to the drug-eluting stent in terms of the Device-Oriented Composite Endpoint (DoCE) in patients undergoing percutaneous coronary intervention for de novo lesions.

Conditions

• De Novo Stenosis
• Coronary 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.

Sponsors & Collaborators

• Xijing Hospital

  lead OTHER

Principal Investigators

• Ling Tao, M.D., Ph.D. · Xijing Hospital

• Patrick Serruys, M.D., Ph.D. · National University of Ireland, Galway

• Yoshinobu Onuma, M.D., Ph.D. · National University of Ireland, Galway

• Chao Gao, M.D., Ph.D. · The First Affiliated Hospital of USTC

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-12-20

Primary Completion

2030-12-20

Completion

2073-12-20

Countries

• China

Study Locations