A Study to Evaluate Safety and Feasibility of PiCSO Therapy in Patients With ST Elevation Inferior Wall Myocardial Infarction. (PiCSO-AMI-V)

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Inferior Wall Myocardial Infarction; STEMI - ST Elevation Myocardial Infarction
• Intervention / Treatment: Device: PiCSO Impulse System

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.

• Study Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clinical Affairs; Phone Number: +32 4 220 88 00; Email: clinical@miracormedical.com

Study Locations

• Denmark
  • Aarhus, Denmark
    • Not yet recruiting
    • Aarhus Universitetshospital
    • Contact: Christian Juhl Terkelsen, Prof.
  • Odense, Denmark
    • Not yet recruiting
    • Odense Universitetshospital
    • Contact: Jens Flensted-Lassen, Prof.
• France
  • Bordeaux, France
    • Recruiting
    • CHU Hôpiteaux de Bordeaux, Hôpital Haut Lévéque
    • Contact: Pierre Coste, Prof.
  • Lille, France
    • Recruiting
    • Centre Hospitalier Régional Universitaire de Lille
    • Contact: Eric Van Belle, Prof.
  • Toulouse, France, 31059
    • Recruiting
    • Centre Hospitalier Universitaire de Toulouse
    • Contact: Didier Carrié, Prof.
• Latvia
  • Riga, Latvia
    • Not yet recruiting
    • Pauls Stradins Clinical University Hospital
• Switzerland
  • Bern, Switzerland
    • Recruiting
    • Bern University Hospital
    • Contact: Lukas Hunziker, MD
  • Lugano, Switzerland
    • Recruiting
    • EOC Ospedale Regionale di Lugano - Civico
    • Contact: Marco Valgimigli, Prof.
• United Kingdom
  • Clydebank, United Kingdom
    • Not yet recruiting
    • Golden Jubilee National Hospital
    • Contact: Colin Berry, Prof.
  • Edinburgh, United Kingdom
    • Not yet recruiting
    • New Edinburgh Royal Infirmary
    • Contact: Miles Behan, MD
  • Oxford, United Kingdom, OX3 9DU
    • Recruiting
    • John Radcliffe Hospital
    • Contact: Adrian Banning, Prof.

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. 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.

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 Impulse System; After blood 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. 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Device Effect (ADE) rate at 30 days post index procedure	Adverse Device Effect (ADE) rate at 30 days post index procedure	30 days post MI

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A severity index derived as the mean wall motion score within the region of AWM	1. Changes in left and right ventricular function assed by echocardiogram performed within 12 to 36 hours of index PCI and 6 months post index PCI	12 to 36 hours and 6 months post MI
Ejection fraction using measured by Simpson's method with 2 apical view	1. Changes in left and right ventricular function assed by echocardiogram performed within 12 to 36 hours of index PCI and 6 months post index PCI	12 to 36 hours and 6 months post MI
The absolute size of the region of abnormal wall motion (AWM)	1. Changes in left and right ventricular function assed by echocardiogram performed within 12 to 36 hours of index PCI and 6 months post index PCI	12 to 36 hours and 6 months post MI
Percentage of the endocardium involved (%AWM)	1. Changes in left and right ventricular function assed by echocardiogram performed within 12 to 36 hours of index PCI and 6 months post index PCI	12 to 36 hours and 6 months post MI
Wall motion score	1. Changes in left and right ventricular function assed by echocardiogram performed within 12 to 36 hours of index PCI and 6 months post index PCI	12 to 36 hours and 6 months post MI
hs-Troponin	Maximum and AUC of hs-Troponin	hospital admission, 6h, 12h, 24h and then daily until day 5 after PCI or discharge
C-reactive protein	Maximum, AUC and velocity of C-reactive protein	hospital admission, 6h, 12h, 24h and then daily until day 5 after PCI or discharge
CK-MB	Maximum and AUC of CK-MB	hospital admission, 6h, 12h, 24h and then daily until day 5 after PCI or discharge
Blushing index	Blushing index at the end of the procedure	Immediately after treatment
ST-segment resolution	ST-segment resolution at 60-90 minutes post flow restoration	60-90 minutes post flow restoration
Device success and procedural success rate presented as % of subjects	Device and Procedural success, assessed as percent of subjects with successful access, delivery, and retrieval of the device and its delivery system	1 day

Collaborators and Investigators

• Sponsor: Miracor Medical SA
• Investigators: Principal Investigator: Adrian Banning, Prof., John Radcliffe Hospital, Oxford

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2022
• Primary Completion (Anticipated): December 30, 2022
• Study Completion (Anticipated): January 30, 2024

Study Registration Dates

• First Submitted: June 29, 2021
• First Submitted That Met QC Criteria: July 8, 2021
• First Posted (Actual): July 12, 2021

Study Record Updates

• Last Update Posted (Actual): April 6, 2022
• Last Update Submitted That Met QC Criteria: April 5, 2022
• Last Verified: April 1, 2022

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; ST Elevation Myocardial Infarction; Inferior Wall Myocardial Infarction
• Other Study ID Numbers: MIR-CIP 0005

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