Bioresorbable Sirolimus-eluting scaffold in de Novo Coronary Artery Lesions

NCT ID: NCT07022587

Last Updated: 2026-02-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-20
• Study Completion Date: 2073-12-20

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Bioresorbable scaffold (BRS)

Group Type: EXPERIMENTAL

Sirolimus-eluting bioresorbable scaffolds

Intervention Type: DEVICE

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.

Drug-eluting stents (DES)

Group Type: ACTIVE_COMPARATOR

Sirolimus-eluting stents

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Patients with an indication for PCI due to acute or chronic coronary syndrome

2. Patients who understand the study's objectives, voluntarily participate, sign the informed consent form, and are willing to undergo regular follow-up

1. De novo lesion(s)

2. Target vessel diameter of ≥ 2.5 mm to ≤ 4.00 mm, target lesion length ≤ 25 mm (visual estimation)

3. Target lesion is NOT

1. Severely calcified

2. In-stent restenosis

3. Diffused lesion requiring stent overlapping or more than one stent

4. Located in the left main, aorto-ostial, proximal LAD/LCX/RCA involving vessel ostia (stent coverage required within 3 mm of vessel ostia), surgical graft, myocardial bridge, or chronic total occlusion

5. Bifurcation requiring two stents or involving a side branch that is ≥ 2.5 mm in diameter

6. Located in the target vessel with severe tortuosity

Exclusion Criteria

1. Age < 18 years, or > 75 years

2. Patient is a woman who is pregnant or nursing

3. Patients who have received any stent implantation in the target vessel within one year

4. Patients required long-term oral anticoagulation

5. Known non-adherence to antiplatelet therapy or not suitable for long-term antiplatelet therapy due to high bleeding risk

6. Patients who are allergic to heparin, poly L-lactic acid (PLLA), sirolimus, antiplatelet drugs, or contrast

7. Currently participating in another trial and not yet at its primary endpoint

8. Patients whose life expectancy is less than 3 years

9. Cardiogenic shock

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xijing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ling Tao, MD, PhD

Professor in Cardiology, Director of the Department of Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ling Tao, M.D., Ph.D.

Role: STUDY_CHAIR

Xijing Hospital

Patrick Serruys, M.D., Ph.D.

Role: STUDY_CHAIR

National University of Ireland, Galway

Yoshinobu Onuma, M.D., Ph.D.

Role: STUDY_CHAIR

National University of Ireland, Galway

Chao Gao, M.D., Ph.D.

Role: STUDY_CHAIR

The First Affiliated Hospital of USTC

Locations

Xijing Hospital

Xi'an, Shannxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Chao Gao, M.D., Ph.D.

Role: CONTACT

woshigaochao@gmail.com

+86-18629551066

Ruining Zhang, BSc

Role: CONTACT

ruining-zhang@qq.com

+86-15802990370

Facility Contacts

Chao Gao

Role: primary

charleygao@qq.com

Other Identifiers

KY20252116-C-1

Identifier Type: -

Identifier Source: org_study_id