Ignite Creation Date:
2025-12-24 @ 3:21 PM
Ignite Modification Date:
2026-01-05 @ 6:30 PM
Study NCT ID:
NCT00242892
Status:
COMPLETED
Last Update Posted:
2011-11-29
First Post:
2005-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FROST 4: Study of the Optimal Spreading of a Coronary Stent Guided With Pressure Into the Coronary Arteries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 800}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-03', 'completionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-25', 'studyFirstSubmitDate': '2005-10-20', 'studyFirstSubmitQcDate': '2005-10-20', 'lastUpdatePostDateStruct': {'date': '2011-11-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The first group of patients will have a coronary procedure with stent and his good deployment will be controlled with angiographic images', 'timeFrame': 'during de study', 'description': 'The first group of patients will have a coronary procedure with stent and his'}], 'secondaryOutcomes': [{'measure': 'At 6 months cardiac events will be registered: patients will undergo a scintigraphic and effort test with thallium and a clinical exam', 'timeFrame': 'during the study', 'description': 'At 6 months cardiac events will be registered: patients will undergo a'}, {'measure': 'At 12 and 18 months they will undergo a clinical exam and cardiac events will be registered', 'timeFrame': 'during the study', 'description': 'At 12 and 18 months they will undergo a clinical exam and cardiac events will be registered'}, {'measure': 'Complementary examination', 'timeFrame': 'during the study', 'description': 'Complementary examination'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Deployment stent optimisation', 'Fractional Flow Reserve', 'Stent', 'Restenosis', 'Coronary'], 'conditions': ['Coronary Artery Insufficiency']}, 'descriptionModule': {'briefSummary': 'Hypothesis : it is known that the stent must be well opened out in order to avoid restenosis into the stent. Intra coronary pressure would allow the stent to be well deployed and so the restenose into the stent should diminish.\n\nPrimary purpose : this study intend to test the hypothesis of optimal spreading of coronary stent guided with pressure into coronary arteritis comparing 2 strategies with patients having a coronary procedure with stent, excluded patients with myocardial infarction.', 'detailedDescription': 'It is a randomized study, intending to treat, comparing the optimisation of the opening out of a stent into a coronar artery either guided with angiographic images only or with the assistance of pressure measurements plus angiographic control.\n\nSeveral French centers participate to demonstrate superiority of one strategy. The criterion of principal judgement is the whole of cardiac events, criterion made up with the cardiac death, myocardial infarction, revascularisation by coronary bridging and/or angioplasty and positivity of the effort test.\n\nSecondary criterions are :\n\n* comparing cost to efficacy of the two strategies\n* evaluating the angiographic restenosis into an under group of 200 patients (100 patients into each group)\n* determining the optimal threshold of measurement of intra coronary pressure in a multicentric population\n* comparing the ability of the different stents used to optimised the intra coronary pressure measurements'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient sent to coronal angioplasty with putting of an active stent to treat a restenosis\n\nExclusion Criteria:\n\n* acute myocardial infarction'}, 'identificationModule': {'nctId': 'NCT00242892', 'briefTitle': 'FROST 4: Study of the Optimal Spreading of a Coronary Stent Guided With Pressure Into the Coronary Arteries', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Prospective Study Randomized Multicentric On the Optimization Of the Installation Of Stent By Measurement Of the Intra-Coronary Pressure', 'orgStudyIdInfo': {'id': 'P001003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Intra coronary measures of pressure', 'interventionNames': ['Procedure: Intra coronary measures of pressure']}], 'interventions': [{'name': 'Intra coronary measures of pressure', 'type': 'PROCEDURE', 'description': 'Intra coronary measures of pressure', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': "European Georges Pompidou's Hospital", 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Antoine LAFONT, Pr,MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'Volcano Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}