NCT03625869

Brief 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).

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
145

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2019

Longer than P75 for not_applicable

Geographic Reach
6 countries

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 10, 2018

Completed
12 months until next milestone

Study Start

First participant enrolled

July 25, 2019

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2023

Completed
Last Updated

March 7, 2023

Status Verified

March 1, 2023

Enrollment Period

3.1 years

First QC Date

August 3, 2018

Last Update Submit

March 6, 2023

Conditions

STEMIAnterior MI

Keywords

PiCSOPiCSO Impulse System

Outcome Measures

Primary Outcomes (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

    5 days post MI

Secondary Outcomes (8)

  • Infarct size 6 months post MI

    6 months post MI

  • MVO

    5 days post MI

  • LVEF

    5 days and 6 months post MI

  • LVESV

    5 days and 6 months post MI

  • LVEDV

    5 days and 6 months post MI

  • +3 more secondary outcomes

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

Interventions

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.

PICSO

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Aarhus Universitetshospital

Aarhus, Denmark

Location

Odense University Hospital

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

Klinikum Coburg GmbH

Coburg, Germany

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

Royal Brompton and Harefield Hospital

Harefield, UB9 6JH, United Kingdom

Location

Leeds Teaching Hopsitals

Leeds, LS1 3EX, United Kingdom

Location

Liverpool Heart and Chest Hospital

Liverpool, United Kingdom

Location

St Bartholomew's Hospital

London, United Kingdom

Location

Freeman Hospital

Newcastle, United Kingdom

Location

John Radcliffe Hospital

Oxford, OX3 9DU, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 38626079DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial InfarctionAnterior Wall Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Adrian Banning, Prof.

    Study principal Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Analysis of the primary endpoint, infarct size 5-days post MI assessed by CMR, will be analyzed by an independent Corelab, blinded to the allocated treatment arm.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A prospective, multicenter, randomized (1:1), controlled, study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2018

First Posted

August 10, 2018

Study Start

July 25, 2019

Primary Completion

August 31, 2022

Study Completion

February 6, 2023

Last Updated

March 7, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

DK(2)FR(3)DE(1)LA(1)GB(8)CH(2)