A Prospective, Multi-Center, Open Label, Randomized Controlled, Two Arm Study Evaluating Safety and Efficacy of the Permanent Polymer Zotarolimus Eluting Stent Resolute Integrity Compared to the Polymer Free Amphilimus Eluting Stent Cre8
试验速览
- 阶段
- 4 期
- 发起方
- UMC Utrecht
- 入组人数
- 1,532
- 试验地点
- 3
- 主要终点
- Target Lesion Failure (TLF)
研究概览
简要总结
The study objective is to assess the safety and efficacy of the Permanent Polymer Zotarolimus-Eluting Stent Resolute Integrity™ to the Polymer Free Amphilimus-Eluting Stent Cre8™ compared in an all-comer patient population. 1 month of dual antiplatelet duration will be applied in stable angina pectoris patients. Myocardial infarction patient population will be treated with 12 months of dual antiplatelet therapy.
详细描述
A Prospective, Multi-Center, Open Label, Randomized Controlled, two-arm Study to Evaluate the Safety and Efficacy of the Permanent Polymer Zotarolimus Eluting Stent 'Resolute Integrity™' Compared to Polymer Free Amphilimus Eluting Stent 'Cre8'. Dual Antiplatelet Therapy duration of 1 Month will be applied in stable angina pectoris patient population. Myocardial infarction patient population will be treated with 12 months of dual antiplatelet therapy (DAPT).
One thousand five hundred thirty-two (1532) patients (1:1 randomization Cre8 stent: Resolute Integrity™ stent) will be enrolled in the study, with clinical follow-up at 12 months to assess the primary end point.
After a period of 12 months, a clinical registry will be implemented Information will be collected at 3-years post procedure.
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
- •General Inclusion Criteria:
- •All-comer patients aged 18 years and older
- •Patient has been informed of the nature of the trial and agrees to its provisions and has provided either oral during emergency procedure, followed by written informed consent, or written informed consent in case of an elective procedure as approved by the Medical Research Ethics Committee (MREC) of the respective investigational site
- •Patient is eligible, according to heart team decision if applicable, for PCI with implantation of a drug-eluting stent (DES)
- •Patient has clinical evidence of ischemic heart disease, angina pectoris, myocardial infarction, or silent ischemia
- •Angiographic Inclusion Criteria:
- •All de-novo lesions and all restenotic lesions (whether native coronary or bypass graft), not amenable for treatment with drug eluting balloons
- •All lesions types are allowed: calcified lesions (lesion preparation with scoring/cutting and rotational atherectomy are allowed), thrombus, chronic total occlusion (CTO; randomized after successful wire crossing and pre-dilatation), bifurcation lesions, ostial lesions, bypass graft (venous and arterial) lesions and left main.
- •There is no limit for lesion length; overlapping stents are allowed, or number of lesions or diseased vessels.
- •Target vessel size reference (visual estimation) between 2.5 mm and 4.5 mm.
排除标准
- •Inability to provide informed consent
- •Participation in another study for intracoronary stents that had not reached its primary endpoint
- •Planned surgery within the next 3 months
- •Known intolerance to P2Y12 receptor antagonist that would prevent adherence to DAPT, or intolerance to aspirin, clopidogrel, Ticagrelor, Prasugrel, heparin/bivalirudin, contrast agent (that cannot be adequately premedicated) or component of DES
- •Female of childbearing potential, who are pregnant or are planning to become pregnant
- •Life expectancy of less than 12 months
研究组 & 干预措施
Cre8 stent
PCI with the Polymer Free Amphilimus Eluting Stent 'Cre8™'
干预措施: Cre8 Stent (Device)
Resolute Integrity Stent
Comparison of the Cre8 stent with the Permanent Polymer Zotarolimus Eluting Stent 'Resolute Integrity™'
干预措施: Resolute Integrity stent (Device)
结局指标
主要结局
Target Lesion Failure (TLF)
时间窗: 12 and 36 months
Cardiac death, vessel-related myocardial infarction (QWMI and NQWMI), target lesion revascularization by CABG or PCI
次要结局
- Net Adverse Clinical Events (NACE)(12 and 36 months)
- Target lesion failure (TLF)(12 and 36 months)
- Target vessel revascularization by CABG or PCI (TVR)(12 and 36 months)
- Device, lesion and procedure success at time of baseline procedure(12 and 36 months)
- Stent thrombosis(12 and 36 months)