PeRcutaneous cOronary Intervention of Native Coronary arTery Versus Venous Bypass Graft in Patients With Prior cORonary Artery Bypass Graft Surgery - the PROCTOR Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 221
- 试验地点
- 40
- 主要终点
- Amount and type of Major Adverse Cardiac Events
研究概览
简要总结
Multi-centre, randomised clinical trial with anticipated 17 European centres: in the Netherlands, Belgium, Germany and UK. Patients with a dysfunctional bypass graft with a clinical indication for revascularization will be randomized to either PCI of the native vessel or PCI of the dysfunctional venous bypass graft. 584 patients with a a clinical indication for percutaneous coronary intervention and a dysfunctional graft on the target vesselional venous bypass graft are planned to be enrolled during 3 years.Study objectives: to investigate the clinical and angiographic outcome of native vessel PCI compared to PCI of venous bypass graft in patients with a dysfunctional venous bypass graft with a clinical indication for revascularization. 1 year and 5 years, follow-up will be performed by means of a telephonic visit. After 3 years patients will be admitted to undergo a control invasive angiography.The CT-substudy and the PROCTOR registry is planned to be conducted too.
详细描述
Multi-centre, randomised clinical trial with anticipated 17 European centres: in the Netherlands, Belgium, Germany and UK. Patients with a dysfunctional bypass graft with a clinical indication for revascularization will be randomized to either PCI of the native vessel or PCI of the dysfunctional venous bypass graft. The CT-substudy and the PROCTOR registry is planned to be conducted too (details included in the flow chart).
CCTA substudy Selected patients will be approached for participation in the CCTA substudy of the trial. Participation in this substudy is optional. After written informed consent is obtained patients will undergo a CCTA in an out-patient setting. The CCTA will be performed before the PCI procedure.
PROCTOR registry
Patients can be approached for the registry when :
- PCI have been deemed clinically indicated by the local hartteam, and
- both the lesions in the native vessel and the dysfunctional graft have been deemed technically feasible by the local hartteam,
- the patient does not meet the in- and exclusion criteria for the randomized PROCTOR study or declines to participate in the randomized study.
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
- Single (Participant)
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
- •A significant stenosis (>50% on angiography) in a venous bypass graft
- •The native lesion must be bypassed by a single graft or must be connected to a jump graft at the most distal anastomosis of that graft
- •In jumpgraft lesions, the lesion must be located distally to the second-to-last anastomosis
- •Clinical indication for revascularization as determined by the local heart team (based on symptoms, documented ischemia, and viability).
- •Both the native lesion and the venous graft lesion must be deemed suitable for PCI with a commercially available second generation DES.
- •Informed consent must be obtained
排除标准
- •< 18 years of age
- •Target vessel diameter < 2.5 mm
- •CABG performed less than 1 year prior to inclusion
- •Diameter of the graft > 5.5 mm
- •Aneurysm formation in the bypass graft
- •Heavy burden of thrombus in the bypass graft (>50% of the bypass graft lumen in ≥2 out of 3 of the proximal, middle or distal third of the bypass graft).
- •STEMI at presentation
- •NSTEMI patients with ongoing ischemia
- •Cardiogenic shock
- •Severe kidney disease defined as an eGFR < 30 ml/min.
- •Pregnancy
- •Estimated life expectancy < 3 year
- •Contraindications to PCI
结局指标
主要结局
Amount and type of Major Adverse Cardiac Events
时间窗: 3 year follow up
The total number and specification of major adverse cardiac events (all-cause mortality, non-fatal myocardial infarction, or clinically driven target lesion revascularization).
次要结局
- Amount and type of Major Adverse Cardiac Events(1 and 5 year follow-up)
- Amount of patients that have passed away(1, 3 and 5 year follow-up)
- Number of non-fatal myocardial infarctions(1, 3 and 5 year follow-up)
- Quality of life assessed by RDS(1, 3 and 5 year follow-up)
- Composite score of quality of life(3-year follow-up)
- Number of clinically driven target lesion revascularizations(1, 3 and 5 year follow-up)
- Number of target vessel revascularizations(1, 3 and 5 year follow-up)
- Number of target vessel failure.(1, 3 and 5 year follow-up)
- Number of non-fatal myocardial infarctions.(>48 hours after PCI)
- Number of PCI-related myocardial infarctions.(1, 3 and 5 year follow-up)
- Specific angiographic outcome(3-year follow up)
- Quality of life assessed by SAQ(1, 3 and 5 year follow-up)
- Quality of life assessed by CCS(1, 3 and 5 year follow-up)
研究者
Paul Knaapen
Prinicipal Investigator
Amsterdam UMC, location VUmc