A Randomized Controlled Study to Evaluate the Safety and Efficacy of Pressure-controlled Intermittent Coronary Sinus Occlusion (PiCSO) in Anterior STEMI Patients With TIMI 0-2 at Presentation.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- STEMI - ST Elevation Myocardial Infarction
- Sponsor
- Miracor Medical SA
- Primary Endpoint
- 12% performance goal rate of PiCSO device or PiCSO procedure related adverse events reported through 30 days
- Status
- Withdrawn
- Last Updated
- 3 years ago
Overview
Brief Summary
The objective of this study is to assess the safety and efficacy of Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) as adjunct to percutaneous coronary intervention (PCI) compared to PCI in the setting of acute anterior ST-segment elevation myocardial infarction (STEMI).
Detailed Description
This is a multicenter, randomized (2 PiCSO :1 Control), controlled, pivotal study to evaluate safety and feasibility of Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) therapy in patients with acute anterior ST-segment elevation myocardial infarction (STEMI), presenting with thrombolysis in myocardial infarction (TIMI) 0, 1, or 2 and symptom duration ≤ 12 hours treated adjunct to PCI compared to standard PCI. Patients with an ST-segment elevated anterior infarct eligible for PCI will be invited to participate in the PiCSO-AMI-II anterior 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 at 5 days and 6 months for cardiovascular magnetic resonance imaging (CMR). Follow-up visits will take place at day 5, day 30, 6 months, 1 year, 2 years and 3 years. At every follow-up visit safety data and health status will be documented.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age ≥18 years old
- •Culprit lesion in proximal or mid left anterior descending artery (LAD)
- •Pre-PCI TIMI flow 0, 1 or 2
- •Symptoms onset time consistent with myocardial ischemia (e.g. persistent chest pain, shortness of breath, nausea/vomiting, fatigue, palpitations or syncope) ≤ 12 h
- •Electrocardiogram (ECG) evidence of acute anterior myocardial infarction with ST-elevation ≥ 2 mm (0.2 mV) in 2 or more contiguous anterior precordial ECG leads (one of which should be V2, V3, or V4) 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 IRB/EC specific requirements prior to the procedure.
Exclusion Criteria
- •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%
- •Need for treatment of any vessel other than the LAD (or its branches) during the index procedure or before the 5 ± 2 days study CMR.
- •Known allergy to polyurethanes, polyethylene terephthalate (PET) or stainless steel, both heparin and bivalirudin, or all of clopidogrel, ticagrelor or prasugrel that cannot be adequately pre-medicated
- •Known pregnancy or breastfeeding
- •Known large pericardial effusion or cardiac tamponade
- •Known hemodynamically relevant left to right and right to left shunt
- •Known previous myocardial infraction (MI)
- •Previous coronary artery bypass graft (CABG)
Outcomes
Primary Outcomes
12% performance goal rate of PiCSO device or PiCSO procedure related adverse events reported through 30 days
Time Frame: 30 days post index PCI
Primary safety endpoint is based on a 12% performance goal rate of PiCSO device or PiCSO procedure related adverse events reported through 30 days post treatment in patients randomized to PiCSO Group in which the PiCSO treatment was delivered or attempted to be delivered. These events will consist of the composite of: * Femoral venous access site complications: * Major bleed (BARC 3-5) * Infections requiring systemic (oral or intravenous) antibiotic treatment * Any femoral access site-related events requiring surgery * Coronary sinus dissection requiring percutaneous intervention or surgery * Pericardial effusion or tamponade requiring percutaneous intervention or surgery * Embolization or Thrombosis * Stroke
Difference in myocardial infarct size
Time Frame: 5 days post index PCI
Difference in myocardial infarct size (extent of myocardial necrosis quantified by delayed gadolinium enhancement presented as a percentage of left ventricular (LV) mass) between the PiCSO Group and the Control Group, assessed by CMR at 5±2 days post index PCI.
Secondary Outcomes
- Utilization of health resources(30 days, 6 months and 1, 2, 3 years post index PCI)
- Individual components of the MACE(30 days, 1, 2 and 3 years post index PCI)
- Time to death and heart failure hospitalization(1 year post index PCI)
- Changes in quality of life(30 days, 6 months and 1, 2, 3 years post index PCI)
- Major Adverse Cardiac Event (MACE) at 30 days as well as 1, 2 and 3 years post index PCI(30 days, 1, 2 and 3 years post index PCI)
- Classification of all-cause death(30 days, 6 months, 1, 2 and 3 years post index PCI)
- Occurrence and extent of microvascular obstruction and hemorrhage(5 days post index PCI)
- Myocardial function (LVEF, LVESV, LVEDV)(5 days and 6 months post index PCI)
- ST-segment resolution(60-90 minutes post flow restoration)
- Device success and procedural success rate(Baseline (treatment day))
- Myocardial infarct size (% of LV mass) assessed by CMR at 6 months post index PCI(6 months post index PCI)
- Myocardial Salvage Index and myocardial infarct size(5 days and 6 months post index PCI)