Clinical trial NCT04958421: A Study to Evaluate Safety and Feasibility of PiCSO Therapy in Patients With ST Elevation Inferior Wall Myocardial Infarction.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: STEMI - ST Elevation Myocardial Infarction
Inferior Wall Myocardial Infarction
Keywords: PiCSO
PiCSO Impulse System
Lead sponsor: Miracor Medical SA
Sponsor class: INDUSTRY
First posted: 2021-07-12
Enrollment: 25
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, pilot stage study
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years old
2. Right dominance with culprit lesion in mid or proximal RCA
3. Pre-PCI TIMI flow 0 or 1 in the culprit lesion
4. Symptom onset time consistent with myocardial ischemia (e.g. persistent chest pain, shortness of breath, nausea/vomiting, fatigue, palpitations or syncope) ≤ 12 h
5. 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
6. Emergent PCI will be performed according to national and local hospital guidelines
7. Consent per approved national 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. Large left anterior descending artery providing blood supply beyond the left ventricular apex (supplying part of the inferior wall) as judged by angiography.
5. Known allergy to polyurethanes, PET or stainless steel, both heparin and bivalirudin, or all of clopidogrel, ticagrelor or prasugrel that cannot be adequately premedicated
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. Previous CABG
10. Known neurologic abnormality such as tumor or AV malformation, history of stroke within 6 months, any prior intracranial bleed or any permanent neurologic defect
11. History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), any recent GU or GI bleed (within 3 months)
12. Administration of fibrinolytic therapy within 24 hours prior to enrollment
13. Cardiogenic shock (SBP \< 90 mmHg), need for mechanical circulatory support, intravenous pressor or pre-randomization intubation
14. Patients with cardio-pulmonary resuscitated (CPR) cardiac arrest for more than 5 min or whom baseline neurologic status is not present
15. Patient not suitable for femoral vein access
16. Active participation in another drug or device investigational study that has not reached its primary endpoint
17. Known severe kidney disease (eGFR \<=30 mL/min/1.73 m2 by MDRD formula) or on hemodialysis
18. COPD with home oxygen therapy or on chronic steroid therapy for COPD
19. Unconscious on presentation
20. Patients under judicial protection, legal guardianship or curatorship
21. 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
22. 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
23. Any evidence of active infectious disease, or definite or probable COVID-19 diagnosis within the prior 4 weeks.

Primary outcomes:
measure: Adverse Device Effect (ADE) rate at 30 days post index procedure
timeFrame: 30 days post MI
Secondary outcomes:
measure: A severity index derived as the mean wall motion score within the region of AWM
timeFrame: 12 to 36 hours and 6 months post MI
measure: Ejection fraction using measured by Simpson's method with 2 apical view
timeFrame: 12 to 36 hours and 6 months post MI
measure: The absolute size of the region of abnormal wall motion (AWM)
timeFrame: 12 to 36 hours and 6 months post MI
measure: Percentage of the endocardium involved (%AWM)
timeFrame: 12 to 36 hours and 6 months post MI
measure: Wall motion score
timeFrame: 12 to 36 hours and 6 months post MI
measure: hs-Troponin
timeFrame: hospital admission, 6h, 12h, 24h and then daily until day 5 after PCI or discharge
measure: C-reactive protein
timeFrame: hospital admission, 6h, 12h, 24h and then daily until day 5 after PCI or discharge
measure: CK-MB
timeFrame: hospital admission, 6h, 12h, 24h and then daily until day 5 after PCI or discharge
measure: Blushing index
timeFrame: Immediately after treatment
measure: ST-segment resolution
timeFrame: 60-90 minutes post flow restoration
measure: Device success and procedural success rate presented as % of subjects
timeFrame: 1 day
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus Universitetshospital
city: Odense
country: Denmark
facility: Odense Universitetshospital
city: Bordeaux
country: France
facility: CHU Hôpiteaux de Bordeaux, Hôpital Haut Lévéque
city: Lille
country: France
facility: Centre Hospitalier Régional Universitaire de Lille
city: Toulouse
country: France
facility: Centre Hospitalier Universitaire de Toulouse
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital
city: Bern
country: Switzerland
facility: Bern University Hospital
city: Lugano
country: Switzerland
facility: EOC Ospedale Regionale di Lugano - Civico
city: Clydebank
country: United Kingdom
facility: Golden Jubilee National Hospital
city: Edinburgh
country: United Kingdom
facility: New Edinburgh Royal Infirmary
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
Study officials:
affiliation: John Radcliffe Hospital, Oxford
name: Adrian Banning, Prof.
role: PRINCIPAL_INVESTIGATOR
References: