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

First Randomized Study of Pressure-controlled Intermittent Coronary Sinus Occlusion (PiCSO) in Acute Myocardial Infarction

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).

Study Overview

• Status: Completed
• Conditions: STEMI; Anterior MI
• Intervention / Treatment: Device: PiCSO

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 Type: Interventional
• Enrollment (Actual): 145
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark
    • Aarhus Universitetshospital
  • Odense, Denmark
    • Odense University Hospital
• France
  • Bordeaux, France
    • CHU Hôpiteaux de Bordeaux, Hôpital Haut Lévéque
  • Lille, France
    • Centre Hospitalier Regional Universitaire de Lille
  • Toulouse, France, 31059
    • Centre Hospitalier Universitaire de Toulouse
• Germany
  • Coburg, Germany
    • Klinikum Coburg GmbH
• Latvia
  • Riga, Latvia
    • Pauls Stradins Clinical University Hospital
• Switzerland
  • Bern, Switzerland
    • Bern University Hospital
  • Lugano, Switzerland
    • EOC Ospedale Regionale di Lugano - Civico
• United Kingdom
  • Clydebank, United Kingdom
    • Golden Jubilee National Hospital
  • Edinburgh, United Kingdom
    • New Edinburgh Royal Infirmary
  • Harefield, United Kingdom, UB9 6JH
    • Royal Brompton and Harefield Hospital
  • Leeds, United Kingdom, LS1 3EX
    • Leeds Teaching Hopsitals
  • Liverpool, United Kingdom
    • Liverpool Heart and Chest Hospital
  • London, United Kingdom
    • St Bartholomew's Hospital
  • Newcastle, United Kingdom
    • Freeman Hospital
  • Oxford, United Kingdom, OX3 9DU
    • John Radcliffe Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; This is the actual control group receiving conventional therapy, ie. percutaneous coronary intervention.
Experimental: PICSO; This arm will be treated with Pressure controlled intermittent Coronary Sinus Occlusion (PiCSO) in addition to conventional therapy (percutaneous coronary intervention).	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infarct size 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	5 days post MI

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Miracor Medical SA
• Investigators: Principal Investigator: Adrian Banning, Prof., Study Principal Investigator

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2019
• Primary Completion (Actual): August 31, 2022
• Study Completion (Actual): February 6, 2023

Study Registration Dates

• First Submitted: August 3, 2018
• First Submitted That Met QC Criteria: August 9, 2018
• First Posted (Actual): August 10, 2018

Study Record Updates

• Last Update Posted (Estimate): March 7, 2023
• Last Update Submitted That Met QC Criteria: March 6, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: PiCSO; PiCSO Impulse System
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction
• Other Study ID Numbers: MIR-CIP 0002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No