Coronary Artery Disease, De Novo Stenosis
Conditions
Keywords
bioresorbable vascular scaffold, drug-eluting stent, de novo stenosis, percutaneous coronary intervention
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.
Interventions
DEVICESirolimus-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.
DEVICESirolimus-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
Xijing Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Clinical 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 Angiographic inclusion criteria 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative event rate of Device-oriented Composite Endpoint (DoCE) | 36 months | DoCE is a composite clinical endpoint of cardiovascular death, target vessel myocardial infarction (TV-MI), and clinically and physiologically indicated target lesion revascularization (CPI-TLR). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative event rate of Patient-oriented composite endpoint (PoCE) | 1, 12, 36, and 60 months | PoCE is defined as a composite endpoint including all-cause death, stroke, myocardial infarction, and revascularization |
| Cumulative event rate of Target vessel failure (TVF) | 1, 12, 36, and 60 months | TVF is defined as a composite endpoint including cardiovascular death, TV-MI and clinically and physiologically target vessel revascularization |
| Cumulative event rate of All-cause death | 1, 12, 36, and 60 months | Individual components of PoCE |
| Cumulative event rate of Cardiovascular death | 1, 12, 36, and 60 months | Individual components of the DoCE |
| Cumulative event rate of Stroke | 1, 12, 36, and 60 months | Individual components of PoCE |
| Cumulative event rate of Myocardial infarction | 1, 12, 36, and 60 months | Individual components of PoCE |
| Cumulative event rate of Target vessel myocardial infarction (TV-MI) | 1, 12, 36, and 60 months | Individual components of DoCE |
| Cumulative event rate of Revascularization | 1, 12, 36, and 60 months | Individual components of PoCE |
| Cumulative event rate of Clinically and physiologically indicated target vessel revascularization | 1, 12, 36, and 60 months | Individual components of TVF |
| Cumulative event rate of Clinically and physiologically indicated target lesion revascularization (CPI-TLR) | 1, 12, 36, and 60 months | Individual components of the DoCE |
| Cumulative event rate of Definite/Probable scaffold/stent thrombosis | 1, 12, 36, and 60 months | According to ARC-2 definitions |
| Cumulative event rate of Device-oriented Composite Endpoint (DoCE) | 1, 12, and 60 months | Rates of the DoCE beside the time point of primary endpoint |
| Cumulative event rate of BARC defined type 3 or 5 bleeding events | 1, 12, 36, and 60 months | — |
Countries
China
Contacts
CONTACTChao Gao, M.D., Ph.D.
CONTACTRuining Zhang, BSc
STUDY_CHAIRLing Tao, M.D., Ph.D.
Xijing Hospital
STUDY_CHAIRPatrick Serruys, M.D., Ph.D.
National University of Ireland, Galway
STUDY_CHAIRYoshinobu Onuma, M.D., Ph.D.
National University of Ireland, Galway
STUDY_CHAIRChao Gao, M.D., Ph.D.
The First Affiliated Hospital of USTC
Outcome results
None listed