Clinical trial NCT05497011: A Study to Evaluate the Safety and Efficacy of PiCSO in Anterior STEMI Patients
Official title: 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.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: STEMI - ST Elevation Myocardial Infarction
Anterior Wall Myocardial Infarction
Keywords: PiCSO
PiCSO Impulse System
Lead sponsor: Miracor Medical SA
Sponsor class: INDUSTRY
First posted: 2022-08-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, multicenter, randomized, controlled, parallel-groups
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years old
2. Culprit lesion in proximal or mid left anterior descending artery (LAD)
3. Pre-PCI TIMI flow 0, 1 or 2
4. Symptoms onset time consistent with myocardial ischemia (e.g. persistent chest pain, shortness of breath, nausea/vomiting, fatigue, palpitations or syncope) ≤ 12 h
5. 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
6. Emergent PCI will be performed according to national and local hospital guidelines
7. Consent per approved national IRB/EC specific requirements prior to the procedure.

Exclusion Criteria:

1. Patient transferred from an outside hospital where invasive coronary procedure was attempted (including diagnostic catheterization)
2. Implants or foreign bodies in the coronary sinus
3. Left main disease \>= 50%
4. 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.
5. 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
6. Known pregnancy or breastfeeding
7. Known large pericardial effusion or cardiac tamponade
8. Known hemodynamically relevant left to right and right to left shunt
9. Known previous myocardial infraction (MI)
10. Previous coronary artery bypass graft (CABG)
11. Known neurologic abnormality such as tumor or arteriovenous (AV) malformation, history of stroke within 6 months, any prior intracranial bleed or any permanent neurologic defect
12. History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), any recent genitourinary (GU) or gastrointestinal (GI) bleed (within 3 months)
13. Administration of fibrinolytic therapy within 24 hours prior to enrollment
14. Cardiogenic shock (systolic blood pressure (SBP) \< 90 mmHg), need for mechanical circulatory support, intravenous pressor or pre-randomization intubation
15. Patients with cardio-pulmonary resuscitated (CPR) cardiac arrest for more than 5 min or whom baseline neurologic status is not present
16. Patient not suitable for femoral vein access
17. Contraindication to cardiac magnetic resonance imaging CMR (e.g. claustrophobia, foreign body implants incompatible with CMR, gadolinium intolerance)
18. Active participation in another drug or device investigational study that has not reached its primary endpoint
19. Known severe kidney disease (eGFR \<=30 mL/min/1.73 m2 by MDRD formula) or on hemodialysis
20. Chronic obstructive pulmonary disease (COPD) with home oxygen therapy or on chronic steroid therapy
21. Unconscious on presentation
22. Patients under judicial protection, legal guardianship or curatorship
23. Subject 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
24. 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

Primary outcomes:
measure: 12% performance goal rate of PiCSO device or PiCSO procedure related adverse events reported through 30 days
timeFrame: 30 days post index PCI
measure: Difference in myocardial infarct size
timeFrame: 5 days post index PCI
Secondary outcomes:
measure: Major Adverse Cardiac Event (MACE) at 30 days as well as 1, 2 and 3 years post index PCI
timeFrame: 30 days, 1, 2 and 3 years post index PCI
measure: Individual components of the MACE
timeFrame: 30 days, 1, 2 and 3 years post index PCI
measure: Classification of all-cause death
timeFrame: 30 days, 6 months, 1, 2 and 3 years post index PCI
measure: Time to death and heart failure hospitalization
timeFrame: 1 year post index PCI
measure: Myocardial infarct size (% of LV mass) assessed by CMR at 6 months post index PCI
timeFrame: 6 months post index PCI
measure: Occurrence and extent of microvascular obstruction and hemorrhage
timeFrame: 5 days post index PCI
measure: Myocardial function (LVEF, LVESV, LVEDV)
timeFrame: 5 days and 6 months post index PCI
measure: Myocardial Salvage Index and myocardial infarct size
timeFrame: 5 days and 6 months post index PCI
measure: ST-segment resolution
timeFrame: 60-90 minutes post flow restoration
measure: Device success and procedural success rate
timeFrame: Baseline (treatment day)
measure: Changes in quality of life
timeFrame: 30 days, 6 months and 1, 2, 3 years post index PCI
measure: Utilization of health resources
timeFrame: 30 days, 6 months and 1, 2, 3 years post index PCI
Other outcomes:
Locations:
Study officials:
affiliation: Mount Sinai, New York, US
name: Gregg W. Stone, Prof.
role: PRINCIPAL_INVESTIGATOR
References: