COMPLEX Registry - a Prospective COhort Study to Describe the Management and Outcomes of Patients Presenting with CompLEX and Calcified Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Rate of Major adverse cardiac and cerebrovascular events (MACCE)
研究概览
简要总结
The purpose of the COMPLEX Registry is to prospectively and retrospectively collect baseline, clinical and procedural data of patients who have undergone PCI or CABG for complex and/ or calcified chronic CAD, irrespective of clinical presentation as well as to prospectively collect data about their clinical outcomes. The outcomes will be compared in different clinical subgroups (e.g. PCI vs. CABG). The impact of current PCI techniques/ devices, but also CABG strategies in different clinical settings and coronary artery lesions on cardiovascular outcomes will be assessed.
详细描述
a. PCI cohort - Periprocedural outcomes/ complications to be analyzed represent: final result (e.g. TIMI flow), stent expansion, dissections, perforations, and prevalence of thrombus (assessed by angiography and intravascular imaging) b. CABG cohort - Periprocedural outcomes/ complications to be analyzed include: final result (e.g. graft flow), number and type of grafts, total length of surgery, bypass time, cross-clamp time, median chest-tube output (mL), bleeding, duration of CCU/ ICU stay, re-operation.
c. For the PCI, CABG as well as medically managed cohort, short and long-term clinical outcomes of interest include: unstable angina (UA), stent-/scaffold thrombosis, target lesion failure (TLF), target vessel revascularization (TVR), ischemia driven revascularization, repeat hospitalization, new/worsening heart failure, cardiogenic shock, stroke, bleedings, cardiovascular death and all-cause death.
-
PCI cohort:
-
To describe procedural and clinical performance of various PCI devices including high pressure balloons, scoring, balloons, cutting balloons, rotational atherectomy, orbital atherectomy, intravascular lithotripsy, stent and scaffold devices implanted in patients presenting with complex and calcified chronic CAD
-
To study the impact of different PCI devices and revascularization strategies used for lesion preparation and PCI optimization strategies among patients undergoing PCI
-
To describe early and late angiographic and OCT-findings among complex and calcified coronary artery disease patients treated with various metallic stent and scaffold devices
-
To assess possible predictors for coronary stent implantation or device failure 3. CABG cohort:
a. To describe procedural and clinical performance of various surgical techniques b. To assess outcomes across various surgical cohorts (e.g. urgent vs. elective, diabetic vs. non-diabetic, gender disparities) c. To investigate various CABG revascularization strategies (e.g. off- versus on-pump, "Fully arterial", minimal invasive approach) and their impact on short and long-term outcomes d. To describe perioperative recovery and risk for in-hospital complications (e.g. wound infections, pneumonia) e. To assess possible predictors for graft failure with contemporary surgical techniques 4. Conservative - only medically treated - cohort:
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject >18 years of age
- •Individuals presenting with chronic, complex and/or calcified CAD and requiring PCI or CABG
- •Complex coronary artery disease / lesions must include at least one of the following attributes:
- •Long and/ or heavily calcified coronary lesions
- •In-stent restenosis
- •Chronic total occlusions (CTO)
- •Left main lesions
- •Bifurcation lesions
- •Bypass graft lesions
- •Small vessel disease / coronary microvascular dysfunction (e.g. not amenable to PCI)
- •Subjects must be willing to sign a patient informed consent (PIC) or must have signed the General Consent (GK).
排除标准
- •The presence of any one of the following exclusion criteria will lead to exclusion of the patient.
- •Patient is <18 years of age
- •Patient unwilling or unable to provide informed consent
- •Patients with no complex and calcified CAD
结局指标
主要结局
Rate of Major adverse cardiac and cerebrovascular events (MACCE)
时间窗: 1 year
次要结局
- Rate of ischemia driven TLR(1 year, 2 years, 5 years and 10 years)
- Rate of all-cause mortality(1 year, 2 years, 5 years and 10 years)
- Rate of vascular complications (according to VARC criteria)(1 year, 2 years, 5 years and 10 years)
- Rate of target lesion failure (TLF)(1 year, 2 years, 5 years and 10 years)
- Rate of TIA or stroke(1 year, 2 years, 5 years and 10 years)
- Rate of cardiovascular mortality(1 year, 2 years, 5 years and 10 years)
- Rate of combination of major adverse cardiac and cerebrovascular events (MACCE)(1 year, 2 years, 5 years and 10 years)
- Rate of target vessel revascularization (TVR)(1 year, 2 years, 5 years and 10 years)
- Rate of acute vessel closure(1 year, 2 years, 5 years and 10 years)
- Rate of target lesion revascularization (TLR)(1 year, 2 years, 5 years and 10 years)
- Rate of new AMI (NSTEMI/STEMI)(1 year, 2 years, 5 years and 10 years)
- Rate of bleeding events (access site or non-access site related) according to the BARC classification.(1 year, 2 years, 5 years and 10 years)
研究者
Matthias Bossard
Principal Co-Investigator
Luzerner Kantonsspital