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

Primary Purpose

STEMI, Anterior MI

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
PiCSO
Sponsored by
Miracor Medical SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for STEMI focused on measuring PiCSO, PiCSO Impulse System

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aarhus Universitetshospital
  • Odense University Hospital
  • CHU Hôpiteaux de Bordeaux, Hôpital Haut Lévéque
  • Centre Hospitalier Régional Universitaire de Lille
  • Centre Hospitalier Universitaire de Toulouse
  • Klinikum Coburg GmbH
  • Pauls Stradins Clinical University Hospital
  • Bern University Hospital
  • EOC Ospedale Regionale di Lugano - Civico
  • Golden Jubilee National Hospital
  • New Edinburgh Royal Infirmary
  • Royal Brompton and Harefield Hospital
  • Leeds Teaching Hopsitals
  • Liverpool Heart and Chest Hospital
  • St Bartholomew's Hospital
  • Freeman Hospital
  • John Radcliffe Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

PICSO

Arm Description

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

This arm will be treated with Pressure controlled intermittent Coronary Sinus Occlusion (PiCSO) in addition to conventional therapy (percutaneous coronary intervention).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Infarct size 6 months post MI
Myocardial infarct size (% of LV mass) assessed by CMR at 6 months post index PCI
MVO
Occurrence and extent of microvascular obstruction (MVO, % of LV mass) and hemorrhage assessed by CMR at 5 days post index PCI
LVEF
LVEF assessed by CMR at 5 days and 6 months post index PCI
LVESV
LVESV assessed by CMR at 5 days and 6 months post index PCI
LVEDV
LVEDV assessed by CMR at 5 days and 6 months post index PCI
Myocardial Salvage
Myocardial Salvage Index at 5 days and 6 month post index PCI
ST-segment resolution
ST-segment resolution at 90 minutes post flow restoration
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

Full Information

First Posted
August 3, 2018
Last Updated
March 6, 2023
Sponsor
Miracor Medical SA
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1. Study Identification

Unique Protocol Identification Number
NCT03625869
Brief Title
Pressure-controlled Intermittent Coronary Sinus Occlusion (PiCSO) in Acute Myocardial Infarction
Acronym
PiCSO-AMI-I
Official Title
First Randomized Study of Pressure-controlled Intermittent Coronary Sinus Occlusion (PiCSO) in Acute Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
July 25, 2019 (Actual)
Primary Completion Date
August 31, 2022 (Actual)
Study Completion Date
February 6, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Miracor Medical SA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
STEMI, Anterior MI
Keywords
PiCSO, PiCSO Impulse System

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A prospective, multicenter, randomized (1:1), controlled, study
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
145 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
This is the actual control group receiving conventional therapy, ie. percutaneous coronary intervention.
Arm Title
PICSO
Arm Type
Experimental
Arm Description
This arm will be treated with Pressure controlled intermittent Coronary Sinus Occlusion (PiCSO) in addition to conventional therapy (percutaneous coronary intervention).
Intervention Type
Device
Intervention Name(s)
PiCSO
Intervention Description
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.
Primary Outcome Measure Information:
Title
Infarct size 5 days post MI
Description
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
Time Frame
5 days post MI
Secondary Outcome Measure Information:
Title
Infarct size 6 months post MI
Description
Myocardial infarct size (% of LV mass) assessed by CMR at 6 months post index PCI
Time Frame
6 months post MI
Title
MVO
Description
Occurrence and extent of microvascular obstruction (MVO, % of LV mass) and hemorrhage assessed by CMR at 5 days post index PCI
Time Frame
5 days post MI
Title
LVEF
Description
LVEF assessed by CMR at 5 days and 6 months post index PCI
Time Frame
5 days and 6 months post MI
Title
LVESV
Description
LVESV assessed by CMR at 5 days and 6 months post index PCI
Time Frame
5 days and 6 months post MI
Title
LVEDV
Description
LVEDV assessed by CMR at 5 days and 6 months post index PCI
Time Frame
5 days and 6 months post MI
Title
Myocardial Salvage
Description
Myocardial Salvage Index at 5 days and 6 month post index PCI
Time Frame
5 days and 6 months post MI
Title
ST-segment resolution
Description
ST-segment resolution at 90 minutes post flow restoration
Time Frame
90 minutes
Title
Device and Procedural success, assessed as percent of subjects with successful access, delivery, and retrieval of the device and its delivery system
Description
Device success and procedural success rate presented as % of subjects
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion criteria: 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 Patients under judicial protection, legal guardianship or curatorship
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrian Banning, Prof.
Organizational Affiliation
Study principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus Universitetshospital
City
Aarhus
Country
Denmark
Facility Name
Odense University Hospital
City
Odense
Country
Denmark
Facility Name
CHU Hôpiteaux de Bordeaux, Hôpital Haut Lévéque
City
Bordeaux
Country
France
Facility Name
Centre Hospitalier Régional Universitaire de Lille
City
Lille
Country
France
Facility Name
Centre Hospitalier Universitaire de Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Klinikum Coburg GmbH
City
Coburg
Country
Germany
Facility Name
Pauls Stradins Clinical University Hospital
City
Riga
Country
Latvia
Facility Name
Bern University Hospital
City
Bern
Country
Switzerland
Facility Name
EOC Ospedale Regionale di Lugano - Civico
City
Lugano
Country
Switzerland
Facility Name
Golden Jubilee National Hospital
City
Clydebank
Country
United Kingdom
Facility Name
New Edinburgh Royal Infirmary
City
Edinburgh
Country
United Kingdom
Facility Name
Royal Brompton and Harefield Hospital
City
Harefield
ZIP/Postal Code
UB9 6JH
Country
United Kingdom
Facility Name
Leeds Teaching Hopsitals
City
Leeds
ZIP/Postal Code
LS1 3EX
Country
United Kingdom
Facility Name
Liverpool Heart and Chest Hospital
City
Liverpool
Country
United Kingdom
Facility Name
St Bartholomew's Hospital
City
London
Country
United Kingdom
Facility Name
Freeman Hospital
City
Newcastle
Country
United Kingdom
Facility Name
John Radcliffe Hospital
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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