Multi-center, Open-label, Prospective, Randomized Study to Show Long-term Efficacy of DCB Treatment With Bail-out BRS in Comparison to BRS Treatment of De-novo Native Coronary Artery Lesions in a Relatively Young PCI Population.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Ceric Sàrl
- 入组人数
- 2,256
- 主要终点
- Target-vessel Failure (TVF)
研究概览
简要总结
The goal of this study is to investigate the equivalence in early and long-term efficacy between the two "Leave nothing behind strategies" (Drug-Coated Baloon [DCB] strategy with bail-out BioResorbable Scaffold [BRS] versus BRS strategy) of de-novo native coronary artery lesions in a relatively young Percutaneous Coronary Intervention (PCI) population, to be more specific, Patients with Chronic Coronary Syndromes (CCS) and Acute Coronary Syndrome (ACS) (Non-ST-segment Elevation Myocardial Infarction [NSTEMI] and Unstable angina) between 18-68 years of age scheduled for PCI. The main questions aim to answer are:
DCB strategy with bail-out BRS implantation has equivalent clinical outcomes at 12 months compared to BRS strategy? DCB strategy with bail-out BRS implantation has noninferior angiographic in-segment net gain at 13 months compared to BRS strategy? DCB strategy with bail-out BRS implantation has equivalent clinical outcomes at 60 months compared to BRS strategy?
Participants will be followed at:
- st FU visit - 1 month (in hospital)
- nd FU visit - 6 months (telephone)
- rd FU visit - 365 days±15 days (telephone) - 1Y Primary efficacy endpoint
- th FU visit - 395 days±15 days (in hospital) co-primary efficacy endpoint for the angiographic substudy
- th FU visit - 730 days±30 days (telephone call) - 2Y
- th FU visit - 1095 days±30 days (telephone call) - 3Y
- th FU visit - 1460 days±30 days (telephone call) - 4Y
- th FU visit- 1825 days±30 days (telephone call) - 5Y
详细描述
The Leave Nothing Behind Study is an is an investigator-initiated trial. The Primary efficacy endpoint is target-vessel failure (TVF), defined as the composite of cardiovascular death, target-vessel myocardial infarction or ischemia-driven target-vessel revascularization (TVR) at 12 months.
Co-primary efficacy endpoint (angiographic substudy) is the in-segment net gain at 13 months.
Investigators aim to enroll 2256 patients in the main study and 196 patients in the angiographic substudy.
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
- None
入排标准
- 年龄范围
- 18 Years 至 68 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥ 18 years ≤ 68 years
- •Single vessel or multivessel disease with low to moderate complex de-novo native coronary artery lesions up to 30 mm length and reference vessel diameter 2.75-4.0 mm
- •Maximum of 3 target lesions
- •Maximal cumulative lesion length of all treated lesions 80 mm
- •Signed informed consent for participation in the study
排除标准
- •ST-segment Elevation Myocardial Infarction (STEMI) treatment at index or in the previous 48 hours
- •Severe calcified lesions
- •Bifurcations lesions with planned 2 device strategy
- •Left-Main (LM) disease ≥ 50% diameter stenosis
- •More than 3 target lesions
- •Renal insufficiency with Glomerular Filtration Rate (GFR) < 45 ml/min
- •Life expectancy less than 1 year
- •Known hypersensitivity or allergy to aspirin or P2Y12 receptor inhibitors
- •Incapable of providing written informed consent
- •Pregnant or breastfeeding women
- •Under judicial protection, tutorship, or curatorship
- •Participation in another trial
研究组 & 干预措施
DCB treatment (Mozec SEB)
Mozec SEB is used during the angioplasty (V2) for patients randomized in the DCB arm with bail-out BRS. If the operator considers the results as insufficient, the MeRes100 is also used in the patient.
干预措施: Angioplasty with DCB (bail-out BRS) (Procedure)
BRS treatment (MeRes100)
MeRes100 is used during the angioplasty (V2) for patients randomized in the BRS arm.
干预措施: Angioplasty with DCB (bail-out BRS) (Procedure)
BRS treatment (MeRes100)
MeRes100 is used during the angioplasty (V2) for patients randomized in the BRS arm.
干预措施: Angioplasty with BRS (Procedure)
结局指标
主要结局
Target-vessel Failure (TVF)
时间窗: From enrollment to the end of treatment at 12 months
Target vessel failiure is defined as the composite of cardiovascular death, target-vessel myocardial infarction or ischemia-driven target-vessel revascularization
次要结局
- Target-Vessel Failure (TVF) at 2, 3, 4 and 5 years.(From enrollment to the end of treatment at every year from 2 years until 5 years follow-up)
- Target-Lesion Failure (TLF)(From enrollment to the end of treatment every year until end of 5 years)
- (Bleeding Academic Research Consortium) BARC 2, 3 or 5 bleedings(From enrollment to the end of treatment every year until end of 5 years)
- Net Adverse Clinical Event (NACE)(From enrollment to the end of treatment every year until end of 5 years)
