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

STEMI - ST Elevation Myocardial Infarction Clinical Trial

— PiCSO-AMI-V  

Official title:

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04958421
• Other study ID #: MIR-CIP 0005
• Status: Terminated
• Phase: N/A
• Start date: February 14, 2022
• Est. completion date: February 6, 2023

Study information

• Verified date: April 2022
• Source: Miracor Medical SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: February 6, 2023
• Est. primary completion date: February 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Infarction
• Inferior Wall Myocardial Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction
• STEMI - ST Elevation Myocardial Infarction

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.

Locations

Country	Name	City	State
Denmark	Aarhus Universitetshospital	Aarhus
Denmark	Odense Universitetshospital	Odense
France	CHU Hôpiteaux de Bordeaux, Hôpital Haut Lévéque	Bordeaux
France	Centre Hospitalier Régional Universitaire de Lille	Lille
France	Centre Hospitalier Universitaire de Toulouse	Toulouse
Latvia	Pauls Stradins Clinical University Hospital	Riga
Switzerland	Bern University Hospital	Bern
Switzerland	EOC Ospedale Regionale di Lugano - Civico	Lugano
United Kingdom	Golden Jubilee National Hospital	Clydebank
United Kingdom	New Edinburgh Royal Infirmary	Edinburgh
United Kingdom	John Radcliffe Hospital	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
Miracor Medical SA

Countries where clinical trial is conducted

Denmark,  France,  Latvia,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	hs-Troponin	Maximum and AUC of hs-Troponin	hospital admission, 6h, 12h, 24h and then daily until day 5 after PCI or discharge
Secondary	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
Secondary	CK-MB	Maximum and AUC of CK-MB	hospital admission, 6h, 12h, 24h and then daily until day 5 after PCI or discharge
Secondary	Blushing index	Blushing index at the end of the procedure	Immediately after treatment
Secondary	ST-segment resolution	ST-segment resolution at 60-90 minutes post flow restoration	60-90 minutes post flow restoration
Secondary	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