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STEMIPiCSO-AMI-INCT03625869

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

A study testing PiCSO in people with STEMI and Anterior MI, run by Miracor Medical SA at 17 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
STEMI, Anterior MI
What is being tested?
PiCSO
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
145 participants
Where
17 sitesin 6 countries
Study dates
25 Jul 2019to 6 Feb 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 years old
  • Culprit lesion in proximal or mid LAD
  • Pre-PCI TIMI flow 0 or 1.
  • Symptoms 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 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
  • Patient is deemed eligible for primary PCI
  • STEMI patients: consent as per approved national ethical committee specific requirements prior to the procedure.

Who cannot join

  • Implants or foreign bodies in the coronary sinus
  • Known allergy to polyurethanes, PET or stainless steel
  • Known pregnancy and breastfeeding
  • Pericardial effusion (cardiac tamponade)
  • Central hemodynamically relevant left/right shunt
  • Previous MI or CABG
Show all 16Show fewer
  • History of stroke, TIA or reversible ischemic neurological deficit within last 6 months
  • Known coagulopathy
  • Need for circulatory support or pre-procedural ventilation
  • Patients with cardio-pulmonary resuscitated (CPR) cardiac arrest for more than 5 minutes
  • Patient not suitable for femoral vein access
  • Contraindication to cardiac magnetic resonance imaging (CMR), e.g. claustrophobia, foreign body implants incompatible with CMR, gadolinium intolerance.
  • Active participation in another drug or device investigational study
  • Known severe kidney disease or on hemodialysis
  • Unconscious on presentation
  • Patients under judicial protection, legal guardianship or curatorship

Trial locations and contacts

17 sites in 6 countries.

17 sites in 6 countries

United Kingdom8 sites

  • Golden Jubilee National Hospital

    Clydebank

  • New Edinburgh Royal Infirmary

    Edinburgh

  • Royal Brompton and Harefield Hospital

    Harefield, UB9 6JH

  • Leeds Teaching Hopsitals

    Leeds, LS1 3EX

  • Liverpool Heart and Chest Hospital

    Liverpool

  • St Bartholomew's Hospital

    London

  • Freeman Hospital

    Newcastle

  • John Radcliffe Hospital

    Oxford, OX3 9DU

Other trials in United Kingdom

France3 sites

  • CHU Hôpiteaux de Bordeaux, Hôpital Haut Lévéque

    Bordeaux

  • Centre Hospitalier Régional Universitaire de Lille

    Lille

  • Centre Hospitalier Universitaire de Toulouse

    Toulouse, 31059

Other trials in France

Denmark2 sites

  • Aarhus Universitetshospital

    Aarhus

  • Odense University Hospital

    Odense

Other trials in Denmark

Switzerland2 sites

  • Bern University Hospital

    Bern

  • EOC Ospedale Regionale di Lugano - Civico

    Lugano

Other trials in Switzerland

Germany1 site

  • Klinikum Coburg GmbH

    Coburg

Other trials in Germany

Latvia1 site

  • Pauls Stradins Clinical University Hospital

    Riga

Other trials in Latvia

About this study

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

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).

Read the detailed 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.

Conditions
STEMI, Anterior MI
Being tested
PiCSO
Keywords
PiCSO, PiCSO Impulse System
Medical subject headings
ST Elevation Myocardial Infarction, Anterior Wall Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PiCSODevice

    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.

Study groups in NCT03625869
Study groupRoleWhat they receive
ControlNo interventionThis is the actual control group receiving conventional therapy, ie. percutaneous coronary intervention.
PICSOExperimentalThis arm will be treated with Pressure controlled intermittent Coronary Sinus Occlusion (PiCSO) in addition to conventional therapy (percutaneous coronary intervention).
Receives: Device: PiCSO

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 5 days post MI

Secondary outcomes (8)

  1. Infarct size 6 months post MI

    Myocardial infarct size (% of LV mass) assessed by CMR at 6 months post index PCI

    Measured: 6 months post MI

  2. MVO

    Occurrence and extent of microvascular obstruction (MVO, % of LV mass) and hemorrhage assessed by CMR at 5 days post index PCI

    Measured: 5 days post MI

  3. LVEF

    LVEF assessed by CMR at 5 days and 6 months post index PCI

    Measured: 5 days and 6 months post MI

  4. LVESV

    LVESV assessed by CMR at 5 days and 6 months post index PCI

    Measured: 5 days and 6 months post MI

  5. LVEDV

    LVEDV assessed by CMR at 5 days and 6 months post index PCI

    Measured: 5 days and 6 months post MI

  6. Myocardial Salvage

    Myocardial Salvage Index at 5 days and 6 month post index PCI

    Measured: 5 days and 6 months post MI

  7. ST-segment resolution

    ST-segment resolution at 90 minutes post flow restoration

    Measured: 90 minutes

  8. 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

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2018
  2. Study start25 Jul 2019
  3. Primary completion31 Aug 2022
  4. Study completion6 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A prospective, multicenter, randomized (1:1), controlled, study
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
145 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03625869
Sponsor's protocol ID
MIR-CIP 0002
Acronym
PiCSO-AMI-I
Status last verified
Mar 2023
First submitted
3 Aug 2018
Last updated
7 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • De Maria GL, Greenwood JP, Zaman AG, Carrie D, Coste P, Valgimigli M, Behan M, Berry C, Erglis A, Panoulas VF, Van Belle E, Juhl Terkelsen C, Hunziker Munsch L, Jain AK, Lassen JF, Palmer N, Stone GW, Banning AP. Pressure-Controlled Intermittent Coronary Sinus Occlusion (PiCSO) in Acute Myocardial Infarction: The PiCSO-AMI-I Trial. Circ Cardiovasc Interv. 2024 Apr;17(4):e013675. doi: 10.1161/CIRCINTERVENTIONS.123.013675. Epub 2024 Apr 16.

    PubMed 38626079

Questions about this trial

What is this clinical trial studying?

A study testing PiCSO in people with STEMI and Anterior MI, run by Miracor Medical SA at 17 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United Kingdom, France, Denmark, Switzerland, Germany and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Infarct size 5 days post MI (time frame: 5 days post MI). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03625869, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2023.

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