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

STEMI Clinical Trial

— PiCSO-AMI-I  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03625869
• Other study ID #: MIR-CIP 0002
• Status: Completed
• Phase: N/A
• Start date: July 25, 2019
• Est. completion date: February 6, 2023

Study information

• Verified date: March 2023
• 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 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: February 6, 2023
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• STEMI

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.

Locations

Country	Name	City	State
Denmark	Aarhus Universitetshospital	Aarhus
Denmark	Odense University Hospital	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
Germany	Klinikum Coburg GmbH	Coburg
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	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

Sponsors (1)

Lead Sponsor	Collaborator
Miracor Medical SA

Countries where clinical trial is conducted

Denmark,  France,  Germany,  Latvia,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	LVEF	LVEF assessed by CMR at 5 days and 6 months post index PCI	5 days and 6 months post MI
Secondary	LVESV	LVESV assessed by CMR at 5 days and 6 months post index PCI	5 days and 6 months post MI
Secondary	LVEDV	LVEDV assessed by CMR at 5 days and 6 months post index PCI	5 days and 6 months post MI
Secondary	Myocardial Salvage	Myocardial Salvage Index at 5 days and 6 month post index PCI	5 days and 6 months post MI
Secondary	ST-segment resolution	ST-segment resolution at 90 minutes post flow restoration	90 minutes
Secondary	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