Post-Market Registry to Evaluate the Safety and Efficacy of the The SUPRAFLEX CRUZ™ Sirolimus Eluting Coronary Stent System in the Treatment of an Octo- and Nonagenerian All-Comer Patient Cohort With Coronary Artery Disease - the Cruz Senior Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,017
- 试验地点
- 1
- 主要终点
- Device Oriented Composite Endpoint
研究概览
简要总结
Prospective, multi-centre, open-label, single-armed, non-interventional observational clinical investigation designed to enrol 2000 octo- and nonagenerian all-comer patients with coro-nary artery disease in up to 37 sites in Germany, Switzerland and Austria. Patients underwent PCI using at least one Supraflex Cruz Sirolimus Eluting stent as per current practice and will be followed up for 12 months.
详细描述
This is a prospective, multicentre, open-label, single-armed, non-interventional observa-tional clinical investigation in aged patients (≥80 years) undergoing PCI using at least one Supraflex sirolimus eluting stent as per current practice. The registry is an observational study and patient's participation in this study has no impact on his or her indication for treatment, diagnostics, or therapy. Subjects are supposed to be treated according to cur-rent guidelines and the site's internal directives.
Inclusion in the registry is completely independent of the medical treatment. All products used for the medical treatment should be administered as stated in their SmPCs (Sum-mary of Product Characteristics) and/or Instructions for Use (IFU). Treatment pattern and treatment initiation, continuation, or changes are solely at the discretion of the physician and the patient. There will be no attempt to influence the treatment patterns of any indi-vidual treating physician. All drug subscriptions applied will be in the usual standard of care. Participation in the registry will in no way influence payment or reimbursement for any treatment received by subjects during the study.
The study will be conducted about 37 sites in Germany, Switzerland and Austria and 2000 subjects will be included. A total study duration of about 39 months is assumed, of which about 18 months account for enrolment and 12 months for the follow-up.
Eligible are all patients with chronic- (CCS) or acute- Non-ST-elevation coronary syndrome (NSTE-ACS) and target lesion suitable for PCI with drug-eluting stent (see section 6.3 for detailed eligibility criteria) undergoing PCI using at least one SUPRAFLEX CRUZ™ Sirolimus eluting coronary stent system as per current practice, who will visit consecutively a partici-pating investigation site. It is planned to enroll about 2000 patients in total.
Following discharge, patients will be treated according to clinical routine/guidelines. Hence, no study-specific pre-planned procedures will be performed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 80 Years 至 99 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written consent received from the patient or a legal repre-sentative after the information has been provided.
- •≥ 80 years of age.
- •De-novo or re-stenotic significant stenosis in at least one cor-onary vessel.
- •Patients with NSTE-ACS, unstable angina, stable angina, silent ischemia (no limitation of the number of treated lesions and vessels: planned staged procedures are allowed within 3 months using Supraflex Cruz only).
- •Target lesion suitable for PCI with SUPRAFLEX CRUZ™ Siroli-mus eluting coronary stent system with diameter between 2.0 and 4.5 mm
- •Total lesion length should be from 6-120 mm
排除标准
- •Patients with ST-elevation myocardial infarction (STE-ACS)
- •Hemodynamic instability or cardiogenic shock
- •Known hypersensitivity or contraindication to any component of the study stent or the eluting drug, to media contrast, to dual antiplatelet therapy (DAPT) medication required by cur-rent practice
- •Any co-morbid condition with life expectancy < 1 year or that may result in protocol non-compliance
- •Patients who are participating in another drug or device inves-tigational study, which has not reached its primary endpoint
- •Patients under judicial protection, tutorship or curatorship
结局指标
主要结局
Device Oriented Composite Endpoint
时间窗: 12 month
Device Oriented Composite Endpoint (DOCE as per ARC2) at 12 months defined as compo-site of cardiovascular death, myocardial infarction (MI) not clearly attributable to a non-target vessel and clinically driven target lesion revascularization (TLR)
次要结局
- revascularization rate(6 months and at 12 months.)
- Stent Thrombosis(6 months and at 12 months)
- Device success(12 month)
- Geriatric Assessment - Minimal Mental Status Test(baseline)
- Geriatric Assessment - G8 Questionnaire(baseline)
- Rate of TV-MI and MI not(6 and 12 month)
- All death(6 and 12 month)
- All MI rate(6 and 12 month)
- Clinically indicated TLR(6 and 12 month)
- All TLR rate(6 months and at 12 months.)
- Target Vessel Revascularization (TVR(6 months and at 12 months.)
- Lesion success(12 month)
- Procedure success(12 month)
- Major Bleeding(12 month)
- SAQ(6 months)
- Quality of life PROMIS(6- and 12-months)
- Geriatric Assessment - Bartel Index(baseline)
- Geriatric Assessment - Times up and Go Test(baseline)
- Geriatric Assessment - General Living conditions(baseline)