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Trial record 2 of 7 for:    miracor medical

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

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ClinicalTrials.gov Identifier: NCT03625869
Recruitment Status : Recruiting
First Posted : August 10, 2018
Last Update Posted : September 18, 2019
Sponsor:
Information provided by (Responsible Party):
Miracor Medical SA

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).

Condition or disease Intervention/treatment Phase
STEMI Device: PiCSO Not Applicable

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 having given verbal assent, 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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A prospective, multicenter, randomized (1:1), controlled, study
Masking: Single (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.
Primary Purpose: Treatment
Official Title: First Randomized Study of Pressure-controlled Intermittent Coronary Sinus Occlusion (PiCSO) in Acute Myocardial Infraction
Actual Study Start Date : July 25, 2019
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : December 30, 2023

Arm Intervention/treatment
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).
Device: PiCSO
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 Measures :
  1. Infarct size 5 days post MI [ Time Frame: 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 :
  1. Infarct size 6 months post MI [ Time Frame: 6 months post MI ]
    Myocardial infarct size (% of LV mass) assessed by CMR at 6 months post index PCI

  2. MVO [ Time Frame: 5 days post MI ]
    Occurrence and extent of microvascular obstruction (MVO, % of LV mass) and hemorrhage assessed by CMR at 5 days post index PCI

  3. LVEF [ Time Frame: 5 days and 6 months post MI ]
    LVEF assessed by CMR at 5 days and 6 months post index PCI

  4. LVESV [ Time Frame: 5 days and 6 months post MI ]
    LVESV assessed by CMR at 5 days and 6 months post index PCI

  5. LVEDV [ Time Frame: 5 days and 6 months post MI ]
    LVEDV assessed by CMR at 5 days and 6 months post index PCI

  6. Myocardial Salvage [ Time Frame: 5 days and 6 months post MI ]
    Myocardial Salvage Index at 5 days and 6 month post index PCI

  7. ST-segment resolution [ Time Frame: 90 minutes ]
    ST-segment resolution at 90 minutes post flow restoration

  8. Device and Procedural success, assessed as percent of subjects with successful access, delivery, and retrieval of the device and its delivery system [ Time Frame: 1 day ]
    Device success and procedural success rate presented as % of subjects



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

NSTEMI patients: full written consent prior to the procedure For NSTEMI Roll-in subjects the inclusion criteria 2, 3, 4 and 5 are not applicable.

  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
  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 For NSTEMI Roll-in subjects the exclusion criterion 12 is not applicable.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03625869


Contacts
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Contact: Clinical Affairs +32 4 220 88 00 clinical@miracormedical.com

Locations
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France
Centre Hospitalier Universitaire de Toulouse Not yet recruiting
Toulouse, France, 31059
Contact: Didier Carrié, Prof.         
United Kingdom
Royal Brompton and Harefield Hospital Recruiting
Harefield, United Kingdom, UB9 6JH
Contact: Charles Ilsley, Dr.         
Leeds Teaching Hopsitals Recruiting
Leeds, United Kingdom, LS1 3EX
Contact: John Greenwood, Prof.         
St Bartholomew's Hospital Not yet recruiting
London, United Kingdom
Contact: Ajay Jain, MD         
Freeman Hospital Recruiting
Newcastle, United Kingdom
Contact: Azfar Zaman, Prof.         
John Radcliffe Hospital Recruiting
Oxford, United Kingdom, OX3 9DU
Contact: Adrian Banning, Prof.         
Sponsors and Collaborators
Miracor Medical SA

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Responsible Party: Miracor Medical SA
ClinicalTrials.gov Identifier: NCT03625869     History of Changes
Other Study ID Numbers: MIR-CIP 0002
First Posted: August 10, 2018    Key Record Dates
Last Update Posted: September 18, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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