Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
Study NCT ID:
NCT07140133
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-24
First Post:
2025-07-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dual Anti-Platelet Optimized Stent for High Bleeding Risk Patient
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-21', 'studyFirstSubmitDate': '2025-07-24', 'studyFirstSubmitQcDate': '2025-08-21', 'lastUpdatePostDateStruct': {'date': '2025-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of occurrence of combined endpoint at 335 days: net averse clinical event (death from any cause, infarction and non-fatal stroke) + (BARC major bleeds >3)).', 'timeFrame': 'At 335 days', 'description': 'Validate the non-inferiority of the frequency of occurrence at 335 days after a short DAPT (1 month) of a combined endpoint, net averse clinical event (all-cause death, non-fatal MI and non-fatal stroke) + (BARC major bleeds \\>3) occurring in patients implanted with an HT supreme™ coronary stent in HBR patients to the ultimaster stent (Terumo)'}], 'secondaryOutcomes': [{'measure': 'Comparison of primary endpoint (net averse clinical event (all-cause death, non-fatal MI and non-fatal stroke) + (BARC major bleeds >3) ) frequency in patients with HBR and high ischemic risk.', 'timeFrame': 'At 335 days and one year', 'description': 'the rate of occurrence of the primary endpoint (net averse clinical event (all-cause death, non-fatal MI and non-fatal stroke) + (BARC major bleeds \\>3) ) in patients with HBRand high ischemic risk'}, {'measure': 'Evaluate the one-year frequency of death from any cause', 'timeFrame': 'At 335 days and one year', 'description': 'All-cause death rate'}, {'measure': 'Evaluate the one-year frequency of cardiovascular deaths', 'timeFrame': 'At 335 days and one year', 'description': 'Cardiovascular death rate'}, {'measure': 'Evaluate the one-year incidence of myocardial infarction', 'timeFrame': 'At 335 days and one year', 'description': 'Myocardial infarction rate'}, {'measure': 'Evaluate the one-year incidence of ischemic stroke', 'timeFrame': 'At 335 days and one year', 'description': 'Ischemic stroke rate'}, {'measure': 'Evaluate the one-year frequency of ischemia-driven revascularizations', 'timeFrame': 'One year', 'description': 'ischemia-driven revascularizations rate'}, {'measure': 'Evaluate the one-year incidence of defined stent thrombosis', 'timeFrame': 'One year', 'description': 'defined stent thrombosis rate'}, {'measure': 'Assess the one-year frequency of minor and major bleeding according to Bleeding Academic Research Consortium (BARC)', 'timeFrame': 'One year', 'description': 'minor and major bleeding according to Bleeding Academic Research Consortium (BARC) rate'}, {'measure': 'Evaluate the frequency of other cardiovascular adverse events', 'timeFrame': 'at 335 days and One year', 'description': 'other cardiovascular adverse events rate'}, {'measure': 'Evaluate the rate of serious adverse events related to the device and/or investigation procedure.', 'timeFrame': 'At 335 and One year', 'description': 'Rate of serious adverse events related to the device and/or investigation procedure'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['High Bleeding Risk Patients', 'Cardiology', 'Stent Implantation', 'DAPT(Dual Antiplatelet Therapy)']}, 'descriptionModule': {'briefSummary': 'High risk of bleeding (HBR) is a determining factor for the duration of dual antiplatelet therapy (DAPT). Recent studies have shown that the use of one-month DAPT is beneficial in terms of ischemic as well as hemorrhagic events, particularly in HBR patients, compared with longer DAPT. European guidelines therefore authorize one-month DAPT in HBR patients presenting even an acute coronary syndrome.\n\nThe HT Supreme Drug Coated Coronary Stent System (HT Supreme DES) is designed to promote reendothelialization as quickly as possible. That\'s why the stent is called "HT" Supreme, with "HT" standing for "Healing Targeted", enabling a DAPT of just 1 month in all-comers HBR patients.\n\nThanks to these features, the investigators aim to demonstrate ischemic and hemorrhagic complication rates lower than those found in the literature with other stent.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients scheduled for coronary angiography and meeting the inclusion criteria will be recruited in the cardiology departments of participating centers.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient aged ≥ 18 years\n* Male or female patient requiring a coronary angioplasty procedure according to European recommendations,\n* Patients undergoing revascularization with HT-supreme stents\n* Patient at high risk of bleeding according to ARC HBR definition (9).\n* Patient affiliated to or benefiting from a social security scheme\n* Patient who does not object to research\n\nExclusion Criteria:\n\n* Estimated lifespan \\<1 year,\n* Allergy and any other contraindication to aspirin and/or clopidogrel listed in the summary of product characteristics,\n* Allergy to iodinated contrast media\n* Adults under legal protection (guardianship, curatorship or safeguard of justice).\n* Persons deprived of their liberty by judicial or administrative decision,\n* Patient in a period of relative exclusion from another research protocol,'}, 'identificationModule': {'nctId': 'NCT07140133', 'acronym': 'DIOHR', 'briefTitle': 'Dual Anti-Platelet Optimized Stent for High Bleeding Risk Patient', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Dual Anti-Platelet Optimized Stent for High Bleeding Risk Patient', 'orgStudyIdInfo': {'id': '38RC25.0204'}}, 'contactsLocationsModule': {'locations': [{'zip': '38700', 'city': 'Grenoble', 'state': 'Isère', 'country': 'France', 'contacts': [{'name': 'Clémence Charlon', 'role': 'CONTACT', 'email': 'ccharlon@chu-grenoble.fr', 'phone': '0476766823'}], 'facility': 'Chu Grenoble Alpes', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sino Medical Sciences Technology Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}