A Randomized, Controlled, Pilot Study to Evaluate Safety and Feasibility of Pressure-controlled Intermittent Coronary Sinus Occlusion (PiCSO) Therapy in Patients With ST Elevation Inferior Wall Myocardial Infarction Presenting With TIMI 0 or 1 and Symptom Duration ≤ 12 Hours Treated Adjunct to Percutaneous Coronary Intervention (PCI) Compared to Standard PCI.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 13
- 主要终点
- Adverse Device Effect (ADE) rate at 30 days post index procedure
研究概览
简要总结
The objective of this study is to assess safety and feasibility of Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) therapy in patients with extensive ST elevation inferior wall myocardial infarction presenting with TIMI 0 or 1 and symptom duration ≤ 12 hours undergoing percutaneous coronary intervention (PCI) compared to standard PCI.
详细描述
This is a multicenter, randomized (2 PiCSO :1 Control), controlled, pilot study to evaluate safety and feasibility of Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) therapy in patients with extensive ST elevation inferior wall myocardial infarction presenting with TIMI 0 or 1 and symptom duration ≤ 12 hours treated adjunct to percutaneous coronary intervention (PCI) compared to standard PCI. Patients with an ST-segment elevated inferior infarct eligible for PCI will be invited to participate in the PiCSO-AMI-V Inferior STEMI study. After consent as per approved ethics committee requirements, baseline assessments will be performed. PCI of the culprit vessel should be performed per standard practices. After TIMI flow restoration, the subjects meeting all eligibility criteria will be enrolled into the study and randomized either to PiCSO Group or Control Group. If the subject is randomized to PiCSO Group, the coronary sinus (CS) will be cannulated through the femoral vein and the PiCSO Impulse Catheter will be placed in the CS. In the event the PiCSO Impulse Catheter cannot be placed in the CS within 30 minutes, the physician should proceed with the regular PCI and the PiCSO treatment will be considered a failure. Once PiCSO Impulse Catheter is placed into CS, PiCSO treatment is started followed by stenting. The physician shall target a PiCSO treatment of 45 minutes whereas the treatment should be continued during and post stent insertion. At the end of the PiCSO treatment, the PiCSO Impulse Console is stopped and the PiCSO Impulse Catheter is removed. The patient is seen for a FU visit at 12-36 hours, 30 days, 6 months and 1 year post index procedure. 12-36 hours and 6 months post index the patient will get a echocardiogram. At every FU visit safety data and health status will be documented.
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 (Outcomes Assessor)
盲法说明
Analysis of the secondary efficacy endpoint, changes in left and right ventricular function, will be analyzed by an independent Corelab, blinded to the allocated treatment arm.
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
- •Age ≥18 years old
- •Right dominance with culprit lesion in mid or proximal RCA
- •Pre-PCI TIMI flow 0 or 1 in the culprit lesion
- •Symptom onset time consistent with myocardial ischemia (e.g. persistent chest pain, shortness of breath, nausea/vomiting, fatigue, palpitations or syncope) ≤ 12 h
- •ECG evidence of acute inferior myocardial infarction with ST-elevation ≥ 2 mm (0.2 mV) in 2 or more contiguous inferior precordial ECG leads (II, III, AVF) in men or ≥ 1.5 mm (0.15 mV) in women
- •Emergent PCI will be performed according to national and local hospital guidelines
- •Consent per approved national EC specific requirements prior to the procedure.
排除标准
- •Patient transferred from an outside hospital where invasive coronary procedure was attempted (including diagnostic catheterization)
- •Implants or foreign bodies in the coronary sinus
- •Left main disease >= 50%
- •Large left anterior descending artery providing blood supply beyond the left ventricular apex (supplying part of the inferior wall) as judged by angiography.
- •Known allergy to polyurethanes, PET or stainless steel, both heparin and bivalirudin, or all of clopidogrel, ticagrelor or prasugrel that cannot be adequately premedicated
- •Known pregnancy or breastfeeding
- •Known large pericardial effusion or cardiac tamponade
- •Known hemodynamically relevant left to right and right to left shunt
- •Previous CABG
- •Known neurologic abnormality such as tumor or AV malformation, history of stroke within 6 months, any prior intracranial bleed or any permanent neurologic defect
- •History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), any recent GU or GI bleed (within 3 months)
- •Administration of fibrinolytic therapy within 24 hours prior to enrollment
- •Cardiogenic shock (SBP < 90 mmHg), need for mechanical circulatory support, intravenous pressor or pre-randomization intubation
- •Patients with cardio-pulmonary resuscitated (CPR) cardiac arrest for more than 5 min or whom baseline neurologic status is not present
- •Patient not suitable for femoral vein access
- •Active participation in another drug or device investigational study that has not reached its primary endpoint
- •Known severe kidney disease (eGFR <=30 mL/min/1.73 m2 by MDRD formula) or on hemodialysis
- •COPD with home oxygen therapy or on chronic steroid therapy for COPD
- •Unconscious on presentation
- •Patients under judicial protection, legal guardianship or curatorship
- •Patient has other medical illness (e.g., cancer, dementia) or known history of substance abuse (alcohol, cocaine, heroin, etc.) that may cause non-compliance with the protocol, confound the data interpretation, or is associated with limited life expectancy of less than 1 year
- •Patients with definite or probable COVID-19 diagnosis > 4 weeks prior to the current MI unless they had returned to their baseline state of health after recovery from the COVID-19 illness
- •Any evidence of active infectious disease, or definite or probable COVID-19 diagnosis within the prior 4 weeks.
结局指标
主要结局
Adverse Device Effect (ADE) rate at 30 days post index procedure
时间窗: 30 days post MI
Adverse Device Effect (ADE) rate at 30 days post index procedure
次要结局
- hs-Troponin(hospital admission, 6h, 12h, 24h and then daily until day 5 after PCI or discharge)
- The absolute size of the region of abnormal wall motion (AWM)(12 to 36 hours and 6 months post MI)
- Percentage of the endocardium involved (%AWM)(12 to 36 hours and 6 months post MI)
- Blushing index(Immediately after treatment)
- ST-segment resolution(60-90 minutes post flow restoration)
- CK-MB(hospital admission, 6h, 12h, 24h and then daily until day 5 after PCI or discharge)
- A severity index derived as the mean wall motion score within the region of AWM(12 to 36 hours and 6 months post MI)
- Ejection fraction using measured by Simpson's method with 2 apical view(12 to 36 hours and 6 months post MI)
- Wall motion score(12 to 36 hours and 6 months post MI)
- C-reactive protein(hospital admission, 6h, 12h, 24h and then daily until day 5 after PCI or discharge)
- Device success and procedural success rate presented as % of subjects(1 day)