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临床试验/NCT07038408
NCT07038408尚未招募不适用

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.

Ceric Sàrl0 个研究点目标入组 2,256 人开始时间: 2026年5月15日最近更新:
干预措施

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:

  1. st FU visit - 1 month (in hospital)
  2. nd FU visit - 6 months (telephone)
  3. rd FU visit - 365 days±15 days (telephone) - 1Y Primary efficacy endpoint
  4. th FU visit - 395 days±15 days (in hospital) co-primary efficacy endpoint for the angiographic substudy
  5. th FU visit - 730 days±30 days (telephone call) - 2Y
  6. th FU visit - 1095 days±30 days (telephone call) - 3Y
  7. th FU visit - 1460 days±30 days (telephone call) - 4Y
  8. 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

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)

Experimental

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)

Active Comparator

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)

Active Comparator

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)

研究者

发起方
Ceric Sàrl
申办方类型
Industry
责任方
Sponsor

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