Clinical trial NCT03625869: Pressure-controlled Intermittent Coronary Sinus Occlusion (PiCSO) in Acute Myocardial Infarction
Official title: First Randomized Study of Pressure-controlled Intermittent Coronary Sinus Occlusion (PiCSO) in Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: STEMI
Anterior MI
Keywords: PiCSO
PiCSO Impulse System
Lead sponsor: Miracor Medical SA
Sponsor class: INDUSTRY
First posted: 2018-08-10
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective, multicenter, randomized (1:1), controlled, study
Primary purpose: TREATMENT

Brief summary: The objective of this study is to assess efficacy and safety of Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) therapy started post flow restoration but prior to stenting during percutaneous coronary intervention (PCI) compared to standard PCI in the setting of acute ST-segment elevation anterior myocardial infarction (STEMI).

Detailed description: This is a prospective, multicenter, randomized (1:1), controlled, study. Patients with an ST-segment elevated anterior infarct eligible for PCI will be invited to participate in the PiCSO-AMI-I study. After consent as per pproved ethics committee requirements, baseline assessments will be performed. PCI of the culprit vessel should be performed per standard practices. After blood flow restoration, the subjects meeting all inclusion and none exclusion criterial 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 (at minimum 30 minutes) whereas the treatment should be continued during and post stent insertion, but should not exceed a maximum duration of 90 minutes. 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 5 days, 30 days, 6 months, 1 year, 2 year and 3 years post index procedure. 5 days and 6 months post index the patient will get a CMR scan. At every FU visit safety data and health status will be documented and quality of life questionnaire will be completed.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years old
2. Culprit lesion in proximal or mid LAD
3. Pre-PCI TIMI flow 0 or 1.
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. 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. Patient is deemed eligible for primary PCI
7. STEMI patients: consent as per approved national ethical committee specific requirements prior to the procedure.

Exclusion criteria:

1. Implants or foreign bodies in the coronary sinus
2. Known allergy to polyurethanes, PET or stainless steel
3. Known pregnancy and breastfeeding
4. Pericardial effusion (cardiac tamponade)
5. Central hemodynamically relevant left/right shunt
6. Previous MI or CABG
7. History of stroke, TIA or reversible ischemic neurological deficit within last 6 months
8. Known coagulopathy
9. Need for circulatory support or pre-procedural ventilation
10. Patients with cardio-pulmonary resuscitated (CPR) cardiac arrest for more than 5 minutes
11. Patient not suitable for femoral vein access
12. Contraindication to cardiac magnetic resonance imaging (CMR), e.g. claustrophobia, foreign body implants incompatible with CMR, gadolinium intolerance.
13. Active participation in another drug or device investigational study
14. Known severe kidney disease or on hemodialysis
15. Unconscious on presentation
16. Patients under judicial protection, legal guardianship or curatorship

Primary outcomes:
measure: Infarct size 5 days post MI
timeFrame: 5 days post MI
Secondary outcomes:
measure: Infarct size 6 months post MI
timeFrame: 6 months post MI
measure: MVO
timeFrame: 5 days post MI
measure: LVEF
timeFrame: 5 days and 6 months post MI
measure: LVESV
timeFrame: 5 days and 6 months post MI
measure: LVEDV
timeFrame: 5 days and 6 months post MI
measure: Myocardial Salvage
timeFrame: 5 days and 6 months post MI
measure: ST-segment resolution
timeFrame: 90 minutes
measure: Device and Procedural success, assessed as percent of subjects with successful access, delivery, and retrieval of the device and its delivery system
timeFrame: 1 day
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus Universitetshospital
city: Odense
country: Denmark
facility: Odense University Hospital
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: Coburg
country: Germany
facility: Klinikum Coburg GmbH
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: Harefield
country: United Kingdom
facility: Royal Brompton and Harefield Hospital
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hopsitals
city: Liverpool
country: United Kingdom
facility: Liverpool Heart and Chest Hospital
city: London
country: United Kingdom
facility: St Bartholomew's Hospital
city: Newcastle
country: United Kingdom
facility: Freeman Hospital
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
Study officials:
affiliation: Study principal Investigator
name: Adrian Banning, Prof.
role: PRINCIPAL_INVESTIGATOR
References: