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

NCT ID: NCT03625869

Last Updated: 2023-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 145 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-25
• Study Completion Date: 2023-02-06

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.

Conditions

STEMI; Anterior MI

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control

This is the actual control group receiving conventional therapy, ie. percutaneous coronary intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

PICSO

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

Group Type: EXPERIMENTAL

PiCSO

Intervention Type: DEVICE

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. 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.

Interventions

PiCSO

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. 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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Miracor Medical SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adrian Banning, Prof.

Role: PRINCIPAL_INVESTIGATOR

Study principal Investigator

Locations

Aarhus Universitetshospital

Aarhus, , Denmark

Odense University Hospital

Odense, , Denmark

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

Leeds Teaching Hopsitals

Leeds, , United Kingdom

Liverpool Heart and Chest Hospital

Liverpool, , United Kingdom

St Bartholomew's Hospital

London, , United Kingdom

Freeman Hospital

Newcastle, , United Kingdom

John Radcliffe Hospital

Oxford, , United Kingdom

Countries

Denmark; France; Germany; Latvia; Switzerland; United Kingdom

References

De Maria GL, Greenwood JP, Zaman AG, Carrie D, Coste P, Valgimigli M, Behan M, Berry C, Erglis A, Panoulas VF, Van Belle E, Juhl Terkelsen C, Hunziker Munsch L, Jain AK, Lassen JF, Palmer N, Stone GW, Banning AP. Pressure-Controlled Intermittent Coronary Sinus Occlusion (PiCSO) in Acute Myocardial Infarction: The PiCSO-AMI-I Trial. Circ Cardiovasc Interv. 2024 Apr;17(4):e013675. doi: 10.1161/CIRCINTERVENTIONS.123.013675. Epub 2024 Apr 16.

Reference Type: DERIVED

PMID: 38626079 (View on PubMed)

Other Identifiers

MIR-CIP 0002

Identifier Type: -

Identifier Source: org_study_id