Selution DeNovo - A Prospective Randomized, Multi-centre, International, Open Label, Clinical Trial Comparing the Selution DEB Strategy Versus DES Strategy.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 3,326
- 试验地点
- 111
- 主要终点
- TVF
研究概览
简要总结
A Prospective Randomized, Multi-centre, International, Open Label, Clinical trial comparing the Selution DEB strategy versus DES strategy.
详细描述
Randomized, multi-centre, international, open label, clinical trial. Patients meeting eligibility criteria will be randomized 1:1 to treatment of all lesions of the identified trial target vessel(s) with either the SELUTION SLR DEB or DES.
Patients randomized to the SELUTION SLR DEB arm will receive lesion preparation according to the 3rd DCB consensus (optimal balloon angioplasty with adjunct treatment using high-pressure balloon, shockwave, rotational atherectomy or cutting or scoring balloon at the discretion of the operator when necessary to maximize lumen diameter). Patients with lesions that are then best treated by provisional stenting (flow-limiting dissection, residual stenosis > 30% or FFR < 0.8) before or after use of DEB will receive a DES but remain in the SELUTION DEB group (intention to treat analysis).
Patients randomized to the DES arm will receive treatment using any CE-marked DES, as per standard institutional practice. Patients with failure to deliver DES will be first treated by provisional DEB using the SELUTION DEB, and failing that, with any other device deemed appropriate.
Staged procedures are allowed if they are planned less than 45 days after the index procedure and are done according to the initial treatment allocation for all trial target vessels (DEB if DEB arm, DES if DES arm).
The study will test:
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must meet all the following criteria to participate in the trial:
- •Subject age is ≥ 18 years (or 21 according to countries legal age)
- •Female subjects of childbearing potential have a negative pregnancy test ≤7 days before the procedure or are using a contraceptive device or drug.
- •Documented angina and/or positive functional testing or unstable angina or stabilized NSTEMI presentation.
- •Life expectancy >1 year
- •Written informed consent by the subject or her/his legally authorized representative for participation in the study
- •One or more native target vessel (LAD, LCX or RCA) is considered to require intervention and is suitable for treatment of all lesions with either DEB + provisional stenting or with DES and is identified as such.
- •The number of trial target lesions is not limited, but in the operator's opinion, if the subject is randomized to the DEB arm, the likelihood of the subject requiring provisional stenting of any of the identified trial target lesions is < 30%, and if randomized to the systematic DES arm, all lesions are considered amenable to stenting.
- •All target lesions: diameter between 2.0 and 5 mm, and diameter stenosis >50% and <100% with distal flow at least TIMI 2
排除标准
- •Age < 18 years (or 21 according to countries legal age)
- •Subject is pregnant or breast-feeding
- •Definite or suspected clinically active covid-19 infection
- •Subject is under judicial protection, tutorship or curatorship (for France only)
- •Subject is unable to fully comply with the study protocol
- •Contraindications to dual antiplatelet therapy, sirolimus or its analogues
- •Presentation with STEMI
- •Presentation with NSTEMI and ongoing chest pain or hemodynamic instability
- •Presentation with Killip III (pulmonary oedema) or IV (cardiogenic shock)
- •Chronic NYHA class III or IV heart failure prior to index PCI
- •Known LVEF < 30% prior to index PCI
- •Previous PCI of a trial target vessel at any time
- •Previous PCI of a non-trial target vessel within 30 days
- •Trial target lesion located in the left main or any arterial or venous graft
- •Trial target lesion is chronic total occlusion (CTO) or in-stent restenosis (ISR)
- •Subject considered not able to tolerate at least 30 seconds of coronary occlusion for each trial target lesion
- •RVD of trial target lesion > 5mm
- •Planned major surgery within one month following the procedure
- •Currently participating in another investigational drug or device study that has not completed primary endpoint follow-up
结局指标
主要结局
TVF
时间窗: 5 years after treatment
\- TVF (cardiac death, target-vessel related myocardial infarction (MI) or clinically driven target vessel revascularization (cd-TVR)) at 5 years
TVF
时间窗: 5 years after treatment
\- TVF (cardiac death, target-vessel related myocardial infarction (MI) or clinically driven target vessel revascularization (cd-TVR)) at 5 years
次要结局
- Myocardial Infarction (MI)(30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment)
- Any revascularization(30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment)
- Site-reported stroke(30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment)
- Site-reported BARC 3-5 Bleeding(30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment)
- CD-TVR(30 days after treatment)
- Composite of cardiac death or target vessel MI(30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment)
- All-cause mortality(30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment)
- Net clinical benefit, a combination of freedom from TVF and/or BARC 3-5 bleeding(30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment)
- Death or any MI(30 days after treatment)
- TVF(2, 3, 4, 5 years after treatment)
- Patient-oriented ARC-2 composite endpoint(30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment)
- Device success(30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment)
- Cost-effectiveness of DEB vs. DES after 12 months in selected countries(1, 2, 3, 4 and 5 years after treatment)
- Lesion success(30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment)
- Procedure success(30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment)