A Bioresorbable Sirolimus-eluting scaffold Versus a Metallic Sirolimus-eluting Stent for the Treatment of de Novo Coronary Artery Lesions: a Randomized, Open-label, Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Cumulative event rate of Device-oriented Composite Endpoint (DoCE)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical inclusion criteria
- •Patients with an indication for PCI due to acute or chronic coronary syndrome
- •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
- •De novo lesion(s)
- •Target vessel diameter of ≥ 2.5 mm to ≤ 4.00 mm, target lesion length ≤ 25 mm (visual estimation)
- •Target lesion is NOT
- •Severely calcified
- •In-stent restenosis
- •Diffused lesion requiring stent overlapping or more than one stent
- •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
- •Bifurcation requiring two stents or involving a side branch that is ≥ 2.5 mm in diameter
- •Located in the target vessel with severe tortuosity
排除标准
- •Age < 18 years, or > 75 years
- •Patient is a woman who is pregnant or nursing
- •Patients who have received any stent implantation in the target vessel within one year
- •Patients required long-term oral anticoagulation
- •Known non-adherence to antiplatelet therapy or not suitable for long-term antiplatelet therapy due to high bleeding risk
- •Patients who are allergic to heparin, poly L-lactic acid (PLLA), sirolimus, antiplatelet drugs, or contrast
- •Currently participating in another trial and not yet at its primary endpoint
- •Patients whose life expectancy is less than 3 years
- •Cardiogenic shock
研究组 & 干预措施
Bioresorbable scaffold (BRS)
干预措施: Sirolimus-eluting bioresorbable scaffolds (Device)
Drug-eluting stents (DES)
干预措施: Sirolimus-eluting stents (Device)
结局指标
主要结局
Cumulative event rate of Device-oriented Composite Endpoint (DoCE)
时间窗: 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).
次要结局
- Cumulative event rate of Device-oriented Composite Endpoint (DoCE)(1, 12, and 60 months)
- Cumulative event rate of Patient-oriented composite endpoint (PoCE)(1, 12, 36, and 60 months)
- Cumulative event rate of Target vessel failure (TVF)(1, 12, 36, and 60 months)
- Cumulative event rate of All-cause death(1, 12, 36, and 60 months)
- Cumulative event rate of Cardiovascular death(1, 12, 36, and 60 months)
- Cumulative event rate of Stroke(1, 12, 36, and 60 months)
- Cumulative event rate of Myocardial infarction(1, 12, 36, and 60 months)
- Cumulative event rate of Target vessel myocardial infarction (TV-MI)(1, 12, 36, and 60 months)
- Cumulative event rate of Revascularization(1, 12, 36, and 60 months)
- Cumulative event rate of Clinically and physiologically indicated target vessel revascularization(1, 12, 36, and 60 months)
- Cumulative event rate of Clinically and physiologically indicated target lesion revascularization (CPI-TLR)(1, 12, 36, and 60 months)
- Cumulative event rate of Definite/Probable scaffold/stent thrombosis(1, 12, 36, and 60 months)
- Cumulative event rate of BARC defined type 3 or 5 bleeding events(1, 12, 36, and 60 months)
研究者
Ling Tao, MD, PhD
Professor in Cardiology, Director of the Department of Cardiology
Xijing Hospital