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

NCT04958421 | Terminated

• 1 other identifier: MIR-CIP 0005
• Study Type: interventional
• Target: 25
• Locations: 5 countries
• Sites: 11

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.

Conditions

STEMI - ST Elevation Myocardial Infarction; Inferior Wall Myocardial Infarction

Keywords

PiCSO; PiCSO Impulse System

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• A severity index derived as the mean wall motion score within the region of AWM

  12 to 36 hours and 6 months post MI

• Ejection fraction using measured by Simpson's method with 2 apical view

  12 to 36 hours and 6 months post MI

• The absolute size of the region of abnormal wall motion (AWM)

  12 to 36 hours and 6 months post MI

• Percentage of the endocardium involved (%AWM)

  12 to 36 hours and 6 months post MI

• Wall motion score

  12 to 36 hours and 6 months post MI

Study Arms (2)

Control

NO INTERVENTION

This is the actual control group receiving conventional therapy, ie. percutaneous coronary intervention.

PiCSO

EXPERIMENTAL

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

Interventions

PiCSO Impulse System DEVICE

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.

PiCSO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years old
• Right dominance with culprit lesion in mid or proximal RCA
• Pre-PCI TIMI flow 0 or 1 in the culprit lesion
• Symptom onset time consistent with myocardial ischemia (e.g. persistent chest pain, shortness of breath, nausea/vomiting, fatigue, palpitations or syncope) ≤ 12 h
• 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
• Emergent PCI will be performed according to national and local hospital guidelines
• Consent per approved national EC specific requirements prior to the procedure.

You may not qualify if:

• Patient transferred from an outside hospital where invasive coronary procedure was attempted (including diagnostic catheterization)
• Implants or foreign bodies in the coronary sinus
• Left main disease \>= 50%
• Large left anterior descending artery providing blood supply beyond the left ventricular apex (supplying part of the inferior wall) as judged by angiography.
• Known allergy to polyurethanes, PET or stainless steel, both heparin and bivalirudin, or all of clopidogrel, ticagrelor or prasugrel that cannot be adequately premedicated
• Known pregnancy or breastfeeding
• Known large pericardial effusion or cardiac tamponade
• Known hemodynamically relevant left to right and right to left shunt
• Previous CABG
• Known neurologic abnormality such as tumor or AV malformation, history of stroke within 6 months, any prior intracranial bleed or any permanent neurologic defect
• History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), any recent GU or GI bleed (within 3 months)
• Administration of fibrinolytic therapy within 24 hours prior to enrollment
• Cardiogenic shock (SBP \< 90 mmHg), need for mechanical circulatory support, intravenous pressor or pre-randomization intubation
• Patients with cardio-pulmonary resuscitated (CPR) cardiac arrest for more than 5 min or whom baseline neurologic status is not present
• Patient not suitable for femoral vein access

Sponsors & Collaborators

• Miracor Medical SA: lead

Study Sites (11)

Aarhus Universitetshospital

Aarhus, Denmark

Location

Odense Universitetshospital

Odense, Denmark

Location

CHU Hôpiteaux de Bordeaux, Hôpital Haut Lévéque

Bordeaux, France

Location

Centre Hospitalier Régional Universitaire de Lille

Lille, France

Location

Centre Hospitalier Universitaire de Toulouse

Toulouse, 31059, France

Location

Pauls Stradins Clinical University Hospital

Riga, Latvia

Location

Bern University Hospital

Bern, Switzerland

Location

EOC Ospedale Regionale di Lugano - Civico

Lugano, Switzerland

Location

Golden Jubilee National Hospital

Clydebank, United Kingdom

Location

New Edinburgh Royal Infirmary

Edinburgh, United Kingdom

Location

John Radcliffe Hospital

Oxford, OX3 9DU, United Kingdom

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Inferior Wall Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Adrian Banning, Prof.

  John Radcliffe Hospital, Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, multicenter, randomized, controlled, parallel-groups, pilot stage study

Study Record Dates

• First Submitted: June 29, 2021
• First Posted: July 12, 2021
• Study Start: February 14, 2022
• Primary Completion: February 6, 2023
• Study Completion: February 6, 2023
• Last Updated: March 8, 2023

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2); LA (1); FR (3); CH (2); GB (3)