Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-03-02 @ 5:18 AM
Study NCT ID:
NCT06420505
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Vivo Isar Stent System in Routine Clinical Practice
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D023921', 'term': 'Coronary Stenosis'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062645', 'term': 'Percutaneous Coronary Intervention'}], 'ancestors': [{'id': 'D057510', 'term': 'Endovascular Procedures'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-04', 'studyFirstSubmitDate': '2024-05-14', 'studyFirstSubmitQcDate': '2024-05-14', 'lastUpdatePostDateStruct': {'date': '2024-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'rate of target lesion failure', 'timeFrame': '12 months post-procedure', 'description': '• The rate of target lesion failure at 12 months follow-up defined as the composite endpoint of:\n\n* Cardiac death\n* Myocardial infarction related to the target vessel\n* Clinically documented target lesion revascularization'}], 'secondaryOutcomes': [{'measure': 'Device success rate', 'timeFrame': '12 months post-procedure', 'description': '• Device success rate defined as successful placement and deployment of the device at the target lesion site with successful removal of the delivery system leaving a final residual stenosis \\<30% of the segment of the culprit lesion covered by the stent at 1 year'}, {'measure': 'Procedural success rate', 'timeFrame': '7 days post-procedure', 'description': '* Procedural success rate defined as device success without major ischemia-related adverse cardiac events during hospitalization and up to a maximum of 7 days post-procedure :\n* Cardiac death\n* Any MI\n* Target-vessel MI'}, {'measure': 'Assess reperfusion', 'timeFrame': '12 months post-procedure', 'description': 'Target Lesion Revascularization at 12 months'}, {'measure': '• Evaluate the antiplatelet treatment', 'timeFrame': '12 months post-procedure', 'description': 'antiplatelet consumption during 1 year after the procedure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Artery Coronary Stenosis']}, 'descriptionModule': {'briefSummary': 'The rationale for this observatory is to evaluate clinical outcomes and collect data of the Polymer Free Sirolimus Eluting Coronary Stent System in Real World CAD Patients with follow-up at 12 months. All medications and procedures to be used/ performed in this observatory are commonly used/performed for clinical indications as part of standard of care and have well-defined safety profiles.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all-comers population who qualify for percutaneous coronary intervention (consisting of patients with symptomatic coronary artery disease including chronic coronary syndromes (CCS) and ACS) of any gender, ≥ 18 years old', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥18 years old\n* Ability to provide signed informed consent form.\n* Male or non-pregnant female patient (Pregnancy status to be confirmed verbally from the female patient of reproductive age)\n* Presentation with acute coronary syndrome or chronic coronary syndrome with stable angina or angina equivalent symptoms or with a positive noninvasive test for ischemia or evidence of a functionally significant coronary stenosis.\n* Patient having social security number.\n* Patient treated only with Vivo ISAR stent in case of single or multiple vessel stenting\n\nExclusion Criteria:\n\n* Concurrent participation in another clinical trial.\n* Having benefited from an angioplasty of ≤ 1 month with a stent other than Vivo ISAR.\n* Planned elective surgery in next 6 months\n* Cardiogenic shock/ hemodynamically unstable patients\n* Concurrent medical condition with a life expectancy of less than 12 months\n* History of cerebrovascular accident in the last 6 months.\n* Vulnerable patient under guardianship or curatorship'}, 'identificationModule': {'nctId': 'NCT06420505', 'acronym': 'CELEBRITY', 'briefTitle': 'Evaluation of the Vivo Isar Stent System in Routine Clinical Practice', 'organization': {'class': 'INDUSTRY', 'fullName': 'Translumina GmbH'}, 'officialTitle': 'Multicenter Observatory Evaluating the Polymer-Free Sirolimus Eluting Coronary Stent System VIVO ISAR in Routine Clinical Practice (CELEBRITY Observatory)', 'orgStudyIdInfo': {'id': 'TRANSLUMINA'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Percutaneous Coronary Intervention', 'type': 'DEVICE', 'description': 'The Vivo ISAR is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '13100', 'city': 'Aix-en-Provence', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Luc Maillard, Dr', 'role': 'CONTACT', 'email': 'luc.maillard@laposte.net'}], 'facility': 'Clinique Axium', 'geoPoint': {'lat': 43.5283, 'lon': 5.44973}}, {'zip': '14000', 'city': 'Caen', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Farzin Begui, Pr', 'role': 'CONTACT', 'email': 'beygui-f@chu-caen.fr'}], 'facility': 'CHU CAEN', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '68003', 'city': 'Colmar', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Amine Matari, Dr', 'role': 'CONTACT', 'email': 'amine.matari@diaconat-mulhouse.fr'}], 'facility': 'Hôpital A. Schweitzer - GHCA', 'geoPoint': {'lat': 48.08078, 'lon': 7.35584}}, {'zip': '54271', 'city': 'Essey-lès-Nancy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Julien Lemoine, Dr', 'role': 'CONTACT', 'email': 'ju.lemoine54@gmail.com'}], 'facility': 'Clinique Louis Pasteur', 'geoPoint': {'lat': 48.705, 'lon': 6.22691}}, {'zip': '67500', 'city': 'Haguenau', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Fabien DE POLI, Dr', 'role': 'CONTACT', 'email': 'fabien@ch-haguenau.fr'}], 'facility': 'CH Haguenau', 'geoPoint': {'lat': 48.81557, 'lon': 7.79051}}, {'zip': '13005', 'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Thomas Cuisset, Pr', 'role': 'CONTACT', 'email': 'thomas.cuisset@mail.ap-hm.fr'}], 'facility': 'CHU La Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '13015', 'city': 'Marseille', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Laurent Bonello, Pr', 'role': 'CONTACT', 'email': 'laurent.bonello@ap-hm.fr'}], 'facility': 'Hopital Nord', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '91300', 'city': 'Massy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Philippe Garot, Dr', 'role': 'CONTACT', 'email': 'p.garot@icps.com.fr'}], 'facility': 'HP Jacques Cartier', 'geoPoint': {'lat': 48.72692, 'lon': 2.28301}}, {'zip': '82000', 'city': 'Montauban', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Romain André, Dr', 'role': 'CONTACT', 'email': 'romain-andre@hotmail.fr'}], 'facility': 'Clinique Pont de Chaume', 'geoPoint': {'lat': 44.01759, 'lon': 1.3542}}, {'zip': '44277', 'city': 'Nantes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Ashok Tirouvanziam, Dr', 'role': 'CONTACT', 'email': 'ashok.tirouvanziam@groupeconfluent.fr'}], 'facility': 'Hôpital Privé du Confluent', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '83190', 'city': 'Ollioules', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'La Scala, Dr', 'role': 'CONTACT'}], 'facility': 'Polyclinique Les Fleurs', 'geoPoint': {'lat': 43.1399, 'lon': 5.84766}}, {'zip': '75013', 'city': 'Paris', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Gille Montalescot, Dr', 'role': 'CONTACT', 'email': 'gilles.montalescot@aphp.fr'}], 'facility': 'APHP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '91480', 'city': 'Quincy-sous-Sénart', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Thierry Unterseeh, Dr', 'role': 'CONTACT', 'email': 't.unterseeh@icps.com.fr'}], 'facility': 'HP Claude Galien', 'geoPoint': {'lat': 48.67294, 'lon': 2.53419}}, {'zip': '51000', 'city': 'Reims', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Laurent Faroux, Dr', 'role': 'CONTACT', 'email': 'lfaroux@chu-reims.fr'}], 'facility': 'CHU Reims', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'zip': '76000', 'city': 'Rouen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Matthieu Godin, Dr', 'role': 'CONTACT', 'email': 'mgodin@clinique-sainthilaire.fr'}], 'facility': 'Clinique Saint Hilaire', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '67091', 'city': 'Strasbourg', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Olivier Morel, Pr', 'role': 'CONTACT', 'email': 'Olivier.Morel@chru-strasbourg.fr'}], 'facility': 'CHRU Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '65013', 'city': 'Tarbes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Majdi Abdennadher, Dr', 'role': 'CONTACT', 'email': 'mabdennadher@ch-tarbes-vic.fr'}], 'facility': 'CH de Bigorre', 'geoPoint': {'lat': 43.23407, 'lon': 0.07139}}, {'zip': '31076', 'city': 'Toulouse', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Didier Tchétché, Dr', 'role': 'CONTACT', 'email': 'dtchetche@clinique-pasteur.com'}], 'facility': 'Clinique Pasteur', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '31400', 'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Thibault Lhermusier, Pr', 'role': 'CONTACT', 'email': 'lhermusier.t@chu-toulouse.fr'}], 'facility': 'Chu Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'centralContacts': [{'name': 'Béatrice GODEFROY', 'role': 'CONTACT', 'email': 'beatrice.godefroy@translumina.fr', 'phone': '0623822906', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Thibault Lhermusier, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Toulouse'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Translumina GmbH', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'EVAMED', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}