Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2026-05-27 @ 6:20 AM
Study NCT ID:
NCT03625869
Status:
COMPLETED
Last Update Posted:
2023-03-07
First Post:
2018-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pressure-controlled Intermittent Coronary Sinus Occlusion (PiCSO) in Acute Myocardial Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072657', 'term': 'ST Elevation Myocardial Infarction'}, {'id': 'D056988', 'term': 'Anterior Wall Myocardial Infarction'}], 'ancestors': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': '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.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A prospective, multicenter, randomized (1:1), controlled, study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 145}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-02-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-06', 'studyFirstSubmitDate': '2018-08-03', 'studyFirstSubmitQcDate': '2018-08-09', 'lastUpdatePostDateStruct': {'date': '2023-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Infarct size 5 days post MI', 'timeFrame': '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'}], 'secondaryOutcomes': [{'measure': 'Infarct size 6 months post MI', 'timeFrame': '6 months post MI', 'description': 'Myocardial infarct size (% of LV mass) assessed by CMR at 6 months post index PCI'}, {'measure': 'MVO', 'timeFrame': '5 days post MI', 'description': 'Occurrence and extent of microvascular obstruction (MVO, % of LV mass) and hemorrhage assessed by CMR at 5 days post index PCI'}, {'measure': 'LVEF', 'timeFrame': '5 days and 6 months post MI', 'description': 'LVEF assessed by CMR at 5 days and 6 months post index PCI'}, {'measure': 'LVESV', 'timeFrame': '5 days and 6 months post MI', 'description': 'LVESV assessed by CMR at 5 days and 6 months post index PCI'}, {'measure': 'LVEDV', 'timeFrame': '5 days and 6 months post MI', 'description': 'LVEDV assessed by CMR at 5 days and 6 months post index PCI'}, {'measure': 'Myocardial Salvage', 'timeFrame': '5 days and 6 months post MI', 'description': 'Myocardial Salvage Index at 5 days and 6 month post index PCI'}, {'measure': 'ST-segment resolution', 'timeFrame': '90 minutes', 'description': 'ST-segment resolution at 90 minutes post flow restoration'}, {'measure': 'Device and Procedural success, assessed as percent of subjects with successful access, delivery, and retrieval of the device and its delivery system', 'timeFrame': '1 day', 'description': 'Device success and procedural success rate presented as % of subjects'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PiCSO', 'PiCSO Impulse System'], 'conditions': ['STEMI', 'Anterior MI']}, 'referencesModule': {'references': [{'pmid': '38626079', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥18 years old\n2. Culprit lesion in proximal or mid LAD\n3. Pre-PCI TIMI flow 0 or 1.\n4. Symptoms onset time consistent with myocardial ischemia (e.g. persistent chest pain, shortness of breath, nausea/vomiting, fatigue, palpitations or syncope) ≤ 12 h.\n5. 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\n6. Patient is deemed eligible for primary PCI\n7. STEMI patients: consent as per approved national ethical committee specific requirements prior to the procedure.\n\nExclusion criteria:\n\n1. Implants or foreign bodies in the coronary sinus\n2. Known allergy to polyurethanes, PET or stainless steel\n3. Known pregnancy and breastfeeding\n4. Pericardial effusion (cardiac tamponade)\n5. Central hemodynamically relevant left/right shunt\n6. Previous MI or CABG\n7. History of stroke, TIA or reversible ischemic neurological deficit within last 6 months\n8. Known coagulopathy\n9. Need for circulatory support or pre-procedural ventilation\n10. Patients with cardio-pulmonary resuscitated (CPR) cardiac arrest for more than 5 minutes\n11. Patient not suitable for femoral vein access\n12. Contraindication to cardiac magnetic resonance imaging (CMR), e.g. claustrophobia, foreign body implants incompatible with CMR, gadolinium intolerance.\n13. Active participation in another drug or device investigational study\n14. Known severe kidney disease or on hemodialysis\n15. Unconscious on presentation\n16. Patients under judicial protection, legal guardianship or curatorship'}, 'identificationModule': {'nctId': 'NCT03625869', 'acronym': 'PiCSO-AMI-I', 'briefTitle': 'Pressure-controlled Intermittent Coronary Sinus Occlusion (PiCSO) in Acute Myocardial Infarction', 'organization': {'class': 'INDUSTRY', 'fullName': 'Miracor Medical SA'}, 'officialTitle': 'First Randomized Study of Pressure-controlled Intermittent Coronary Sinus Occlusion (PiCSO) in Acute Myocardial Infarction', 'orgStudyIdInfo': {'id': 'MIR-CIP 0002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'This is the actual control group receiving conventional therapy, ie. percutaneous coronary intervention.'}, {'type': 'EXPERIMENTAL', 'label': 'PICSO', 'description': 'This arm will be treated with Pressure controlled intermittent Coronary Sinus Occlusion (PiCSO) in addition to conventional therapy (percutaneous coronary intervention).', 'interventionNames': ['Device: PiCSO']}], 'interventions': [{'name': 'PiCSO', 'type': 'DEVICE', '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.', 'armGroupLabels': ['PICSO']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Aarhus Universitetshospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'city': 'Odense', 'country': 'Denmark', 'facility': 'Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}, {'city': 'Bordeaux', 'country': 'France', 'facility': 'CHU Hôpiteaux de Bordeaux, Hôpital Haut Lévéque', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Lille', 'country': 'France', 'facility': 'Centre Hospitalier Régional Universitaire de Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Coburg', 'country': 'Germany', 'facility': 'Klinikum Coburg GmbH', 'geoPoint': {'lat': 50.25937, 'lon': 10.96384}}, {'city': 'Riga', 'country': 'Latvia', 'facility': 'Pauls Stradins Clinical University Hospital', 'geoPoint': {'lat': 56.946, 'lon': 24.10589}}, {'city': 'Bern', 'country': 'Switzerland', 'facility': 'Bern University Hospital', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'city': 'Lugano', 'country': 'Switzerland', 'facility': 'EOC Ospedale Regionale di Lugano - Civico', 'geoPoint': {'lat': 46.01008, 'lon': 8.96004}}, {'city': 'Clydebank', 'country': 'United Kingdom', 'facility': 'Golden Jubilee National Hospital', 'geoPoint': {'lat': 55.90137, 'lon': -4.4057}}, {'city': 'Edinburgh', 'country': 'United Kingdom', 'facility': 'New Edinburgh Royal Infirmary', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}, {'zip': 'UB9 6JH', 'city': 'Harefield', 'country': 'United Kingdom', 'facility': 'Royal Brompton and Harefield Hospital', 'geoPoint': {'lat': 51.60333, 'lon': -0.48546}}, {'zip': 'LS1 3EX', 'city': 'Leeds', 'country': 'United Kingdom', 'facility': 'Leeds Teaching Hopsitals', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'city': 'Liverpool', 'country': 'United Kingdom', 'facility': 'Liverpool Heart and Chest Hospital', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'city': 'London', 'country': 'United Kingdom', 'facility': "St Bartholomew's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Newcastle', 'country': 'United Kingdom', 'facility': 'Freeman Hospital', 'geoPoint': {'lat': 54.21804, 'lon': -5.88979}}, {'zip': 'OX3 9DU', 'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'John Radcliffe Hospital', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}], 'overallOfficials': [{'name': 'Adrian Banning, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Study principal Investigator'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Miracor Medical SA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}