Ignite Creation Date:
2025-12-25 @ 2:26 AM
Ignite Modification Date:
2025-12-27 @ 11:49 PM
Study NCT ID:
NCT06813534
Status:
RECRUITING
Last Update Posted:
2025-02-07
First Post:
2023-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IVUS Guided PCI in Patients With Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants are assigned to one of two or more groups in parallel for the duration of the study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 170}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-08-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-03', 'studyFirstSubmitDate': '2023-05-09', 'studyFirstSubmitQcDate': '2025-02-03', 'lastUpdatePostDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of serum creatinine due to nephropathy', 'timeFrame': '30 days', 'description': 'Contrast-induced nephropathy is defined as an increase in creatininemia by 25% from its baseline level. The parameter being measured is creatininemia, which refers to the concentration of creatinine in the blood. The unit of measurement for this increase is a percentage (%)'}], 'secondaryOutcomes': [{'measure': 'Global safety', 'timeFrame': '30 days', 'description': 'The occurrence of death from any cause within 30 days. The unit of measurement is the presence or absence of death.'}, {'measure': 'Endocoronary complications', 'timeFrame': '72 hours', 'description': 'his includes dissection, thrombus formation, breaches, or coronary occlusion that require an additional unplanned intervention. The unit of measurement is the occurrence of these complications, recorded as Yes or No.'}, {'measure': 'Procedural Criteria', 'timeFrame': '72 hours', 'description': 'Procedure time: The total time taken for the procedure. The unit of measurement is time, typically recorded in minutes (min)'}, {'measure': 'Myocardial infarction', 'timeFrame': '30 days', 'description': 'The occurrence of a myocardial infarction within 30 days. The unit of measurement is the presence or absence of the event, recorded as Yes or No."'}, {'measure': 'Global safety : stroke', 'timeFrame': '30 days', 'description': 'Stroke: The occurrence of a stroke within 30 days. The unit of measurement is the presence or absence of the event, recorded as Yes or No'}, {'measure': 'Global safety', 'timeFrame': '30 days', 'description': 'Unplanned hospitalization for cardiac or renal causes: The occurrence of an unplanned hospitalization due to cardiac or renal causes within 30 days. The unit of measurement is the presence or absence of the event, recorded as Yes or No.'}, {'measure': 'Angioplasty failures', 'timeFrame': '72 hours', 'description': 'Angioplasty failures are defined by a residual stenosis of 70% or greater and/or a TIMI flow of less than 3 at the end of the procedure. The unit of measurement for residual stenosis is percentage (%) and for TIMI flow, the unit is a scale from 0 to 3, with a TIMI flow of less than 3 indicating failure.'}, {'measure': 'Procedural Criteria : Fluoroscopy time', 'timeFrame': '72 hours', 'description': 'Fluoroscopy time: The amount of time fluoroscopy imaging is used during the procedure. The unit of measurement is time, typically recorded in minutes (min)'}, {'measure': 'Procedural Criteria: Air Kerma', 'timeFrame': '72 hours', 'description': 'Air Kerma: A measure of the radiation dose delivered during the procedure. The unit of measurement is the Gray (Gy), specifically milligray (mGy) for this context'}, {'measure': 'Procedural Criteria : PDS (Procedure Dose Score)', 'timeFrame': '72 hours', 'description': 'PDS (Procedure Dose Score): A measure of the total radiation dose delivered to the patient during the procedure. The unit of measurement is arbitrary units based on the specific scoring system used.'}, {'measure': 'Procedural Criteria', 'timeFrame': '72 hours', 'description': 'Volume of contrast injected: The amount of contrast material used during the procedure. The unit of measurement is milliliters (mL)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Coronary artery disease', 'chronic kidney disease', 'Contrast induced nephropathy', 'IVUS'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'The incidence of contrast-induced nephropathy (CIN) is high (\\> 25%) in patients with severe chronic renal disease (CKD) who undergo a percutaneous coronary procedure.\n\nThe development of CIN is a factor of poor prognosis and is associated with the occurrence of irreversible CKD, the need for dialysis, increased length of stay and hospital costs as well as the risk of death. There is no specific treatment for N-PCI, so its prevention is essential. Although many studies have been conducted to identify, compare and implement different pharmacological strategies for the prevention of CIN before percutaneous coronary procedurse, few per-procedural strategies have been studied to prevent this risk.\n\nIntracoronary ultrasound (IVUS) is an essential tool, used routinely to guide percutaneous coronary procedures thanks to ultrasound, it does not require the injection of iodine contrast.\n\nThe main objective is to show that an IVUS-guided "zero-contrast" coronary angioplasty strategy in patients with severe renal impairment decreases the incidence of CIN within 72 hours of procedure.', 'detailedDescription': 'The incidence of contrast-induced nephropathy (CIN) is high (\\> 25%) in patients with severe chronic renal disease (CKD) who undergo a percutaneous coronary procedure.\n\nThe development of CIN is a factor of poor prognosis and is associated with the occurrence of irreversible CKD, the need for dialysis, increased length of stay and hospital costs as well as the risk of death. There is no specific treatment for N-PCI, so its prevention is essential. Although many studies have been conducted to identify, compare and implement different pharmacological strategies for the prevention of CIN before percutaneous coronary procedurse, few per-procedural strategies have been studied to prevent this risk.\n\nIntracoronary ultrasound (IVUS) is an essential tool, used routinely to guide percutaneous coronary procedures thanks to ultrasound, it does not require the injection of iodine contrast.\n\nThe main objective is to show that an IVUS-guided "zero-contrast" coronary angioplasty strategy in patients with severe renal impairment decreases the incidence of CIN within 72 hours of procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 18 years old\n* Indication for PCI\n* Chronic kidney disease with creatinine clearance ≤ 30 mL/min/1.73m²\n* Feasibility of IVUS determined by 2 trained interventional cardiologist\n* Affiliated to social security\n\nExclusion Criteria:\n\n* Iodine contrast injection in the previous 72 hours\n* Known allergy to iodine contrast\n* Permanent dialysis\n* Chronic total occlusion\n* Hemodynamic instability\n* Legal protection\n* Pregnant of breastfeeding patients\n* Patients on "AME"'}, 'identificationModule': {'nctId': 'NCT06813534', 'acronym': 'SPEED', 'briefTitle': 'IVUS Guided PCI in Patients With Chronic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': '" Contrast-free " IVUS Guided PCI Compared to Standard Angio-guided PCI in Patient With sEvere kidnEy Disease', 'orgStudyIdInfo': {'id': 'APHP230196'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventionnal PCI', 'description': 'Contrast guided PCI', 'interventionNames': ['Device: Intravascular Ultrasound guided PCI']}, {'type': 'EXPERIMENTAL', 'label': 'IVUS guided PCI', 'description': 'IVUS guided PCI with iodine contrast injection limited (as much as possible) to a final control injection.', 'interventionNames': ['Device: Intravascular Ultrasound guided PCI']}], 'interventions': [{'name': 'Intravascular Ultrasound guided PCI', 'type': 'DEVICE', 'description': 'Intra-coronary ultrasound', 'armGroupLabels': ['Conventionnal PCI', 'IVUS guided PCI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94010', 'city': 'Créteil', 'state': 'Creteil', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Romain GALLET', 'role': 'CONTACT', 'email': 'romain.gallet@aphp.fr', 'phone': '0149812111'}], 'facility': 'Romain GALLET', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '94010', 'city': 'Créteil', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Romain GALLET', 'role': 'CONTACT', 'email': 'romain.gallet@aphp.fr', 'phone': '0149812111'}], 'facility': 'Romain GALLET', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}], 'centralContacts': [{'name': 'Romain GALLET, Pr', 'role': 'CONTACT', 'email': 'romain.gallet@aphp.fr', 'phone': '01 49 81 21 11'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}