Pressure-controlled Intermittent Coronary Sinus Occlusion (PiCSO) in Acute Myocardial Infarction

Not Applicable

Completed

• Conditions: Anterior MI; STEMI
• Interventions: Device: PiCSO

• Registration Number: NCT03625869
• Lead Sponsor: Miracor Medical SA

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.

Study Timeline

• Study First Submitted: 2018-08-03
• Study First Submitted QC: 2018-08-09
• Study First Posted: 2018-08-10
• Study Start: 2019-07-25
• Primary Completion: 2022-08-31
• Study Completion: 2023-02-06
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-06
• Last Update Posted: 2023-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 145

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PICSO	PiCSO	This arm will be treated with Pressure controlled intermittent Coronary Sinus Occlusion (PiCSO) in addition to conventional therapy (percutaneous coronary intervention).

Primary Outcome Measures

Name	Time	Method
Infarct size 5 days post MI	5 days post MI	Difference in myocardial infarct size (extent of myocardial necrosis quantified by delayed gadolinium enhancement presented as a percentage of LV mass) between the PiCSO Group and the Control Group, assessed by CMR at 5 days post index PCI

Secondary Outcome Measures

Name	Time	Method
Myocardial Salvage	5 days and 6 months post MI	Myocardial Salvage Index at 5 days and 6 month post index PCI
LVEDV	5 days and 6 months post MI	LVEDV assessed by CMR at 5 days and 6 months post index PCI
ST-segment resolution	90 minutes	ST-segment resolution at 90 minutes post flow restoration
Infarct size 6 months post MI	6 months post MI	Myocardial infarct size (% of LV mass) assessed by CMR at 6 months post index PCI
MVO	5 days post MI	Occurrence and extent of microvascular obstruction (MVO, % of LV mass) and hemorrhage assessed by CMR at 5 days post index PCI
LVEF	5 days and 6 months post MI	LVEF assessed by CMR at 5 days and 6 months post index PCI
LVESV	5 days and 6 months post MI	LVESV assessed by CMR at 5 days and 6 months post index PCI
Device and Procedural success, assessed as percent of subjects with successful access, delivery, and retrieval of the device and its delivery system	1 day	Device success and procedural success rate presented as % of subjects

Trial Locations

Locations (17)

CHU Hôpiteaux de Bordeaux, Hôpital Haut Lévéque; 🇫🇷 Bordeaux, France

Centre Hospitalier Régional Universitaire de Lille; 🇫🇷 Lille, France

Centre Hospitalier Universitaire de Toulouse; 🇫🇷 Toulouse, France

Klinikum Coburg GmbH; 🇩🇪 Coburg, Germany

Pauls Stradins Clinical University Hospital; 🇱🇻 Riga, Latvia

Bern University Hospital; 🇨🇭 Bern, Switzerland

EOC Ospedale Regionale di Lugano - Civico; 🇨🇭 Lugano, Switzerland

Golden Jubilee National Hospital; 🇬🇧 Clydebank, United Kingdom

New Edinburgh Royal Infirmary; 🇬🇧 Edinburgh, United Kingdom

Royal Brompton and Harefield Hospital; 🇬🇧 Harefield, United Kingdom

Liverpool Heart and Chest Hospital; 🇬🇧 Liverpool, United Kingdom

St Bartholomew's Hospital; 🇬🇧 London, United Kingdom

Leeds Teaching Hopsitals; 🇬🇧 Leeds, United Kingdom

Freeman Hospital; 🇬🇧 Newcastle, United Kingdom

John Radcliffe Hospital; 🇬🇧 Oxford, United Kingdom

Aarhus Universitetshospital; 🇩🇰 Aarhus, Denmark

Odense University Hospital; 🇩🇰 Odense, Denmark