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

• ClinicalTrials.gov Identifier: NCT04958421
• Recruitment Status: Terminated
• First Posted: July 12, 2021
• Last Update Posted: March 8, 2023
• Sponsor: Miracor Medical SA
• Information provided by (Responsible Party): Miracor Medical SA

Tracking Information

• First Submitted Date: June 29, 2021
• First Posted Date: July 12, 2021
• Last Update Posted Date: March 8, 2023
• Actual Study Start Date: February 14, 2022
• Actual Primary Completion Date: February 6, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 8, 2021)

Adverse Device Effect (ADE) rate at 30 days post index procedure [ Time Frame: 30 days post MI ]

Adverse Device Effect (ADE) rate at 30 days post index procedure

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 14, 2021)

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

Original Secondary Outcome Measures (submitted: July 8, 2021)

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

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study to Evaluate Safety and Feasibility of PiCSO Therapy in Patients With ST Elevation Inferior Wall Myocardial Infarction.
• 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.
• Brief 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.
• 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
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Prospective, multicenter, randomized, controlled, parallel-groups, pilot stage study

Masking: Single (Outcomes Assessor)
Masking Description:

Analysis of the secondary efficacy endpoint, changes in left and right ventricular function, will be analyzed by an independent Corelab, blinded to the allocated treatment arm.

Primary Purpose: Treatment

Condition

• STEMI - ST Elevation Myocardial Infarction
• Inferior Wall 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.

Study Arms

• 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).
  Intervention: Device: PiCSO Impulse System

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: March 6, 2023): 25
• Original Estimated Enrollment (submitted: July 8, 2021): 75
• Actual Study Completion Date: February 6, 2023
• Actual Primary Completion Date: February 6, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Denmark, France, Latvia, Switzerland, United Kingdom

Administrative Information

• NCT Number: NCT04958421
• Other Study ID Numbers: MIR-CIP 0005
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Miracor Medical SA
• Original Responsible Party: Same as current
• Current Study Sponsor: Miracor Medical SA
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Adrian Banning, Prof.; John Radcliffe Hospital, Oxford

• PRS Account: Miracor Medical SA
• Verification Date: April 2022