Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-02-09 @ 8:05 AM
Study NCT ID:
NCT03927560
Status:
UNKNOWN
Last Update Posted:
2019-05-01
First Post:
2019-04-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Robotic-Assisted Percutaneous Coronary Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 83}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-06-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2020-03-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-29', 'studyFirstSubmitDate': '2019-04-22', 'studyFirstSubmitQcDate': '2019-04-24', 'lastUpdatePostDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Procedure Complications', 'timeFrame': '1 day', 'description': 'Death or non-fatal major acute complications on the target vessel (thrombosis, myocardial infarction, perforation or non-planned invasive treatment).'}, {'measure': 'Procedure Success', 'timeFrame': '1 day', 'description': 'Robotic Assisted Procedure Success'}], 'secondaryOutcomes': [{'measure': 'Occurence of Major Events', 'timeFrame': '1 month', 'description': 'Death, stent thrombosis, Myocardial Infarction, Stroke'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'Percutaneous coronary intervention is a safe procedure. However, its execution is manual, fully operator-dependent. The procedure is also associated with radiation exposure to patients and physicians. This study will evaluate the robotic assisted percutaneous coronary intervention as an alternative to manual operation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age\\> = 18 years;\n2. Symptomatic ischemic heart disease and / or objective evidence of myocardial ischemia with one or more target lesions;\n3. Elective for percutaneous procedure (i.e. performed in a non-urgent context)\n4. The target lesion (s) must be obstructive, with stenosis diameter \\> 50% (visual analysis);\n5. The interventional planning of all target lesions should include robotic manipulation in at least one treatment, as judged by the operator;\n6. Acceptable candidate for myocardial revascularization surgery.\n\nExclusion Criteria:\n\n1. ST-segment elevation myocardial infarction in the last 48 hours before the index procedure;\n2. Ejection fraction \\<30%;\n3. Impaired renal function (creatinine\\> 2.0 mg / dL) or calculated creatinine clearance \\<30 ml / min;\n4. Platelet count \\<100,000 cells / mm 3 or\\> 700,000 cells / mm 3;\n5. Total Leucocytes count \\<3,000 cells / mm 3;\n6. Suspected or documented active liver disease (including laboratory evidence of hepatitis);\n7. Heart transplant recipient;\n8. Allergies known to aspirin, clopidogrel, ticlopidine, ticagrelor, prasugrel, heparin, antiproliferative agents of the limus family, or stainless steel;\n9. Patient with a life expectancy of less than 1 month;\n10. Any significant medical condition that in the opinion of the investigator may interfere with the patient's ideal participation in this study;\n11. Participation in other research in the last 12 months, unless there may be direct benefit to the research subject;\n12. Any invasive cardiac or non-cardiac treatment scheduled within the first month after the index procedure.\n\nAngiographic exclusion criteria\n\n1. Need for non-robotic (i.e. manual) treatment of another injury in the index procedure or in the first month;\n2. Target lesion not accessible by robotic treatment, according to the judgment of the operator;\n3. Unprotected coronary artery trunk lesion (stenosis\\> 50%);\n4. Angiographic thrombus;\n5. Target lesion in surgical graft;\n6. Total occlusion (TIMI 0 or 1 anterograde flow)"}, 'identificationModule': {'nctId': 'NCT03927560', 'briefTitle': 'Robotic-Assisted Percutaneous Coronary Intervention', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Israelita Albert Einstein'}, 'officialTitle': 'Robotic-Assisted Percutaneous Coronary Intervention - A Safety and Effectiveness Study Applied to the Brazilian Public Health System', 'orgStudyIdInfo': {'id': 'Robotic First'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Robotic Assisted Percutaneous Coronary Intervention', 'interventionNames': ['Procedure: Robotic Assisted Percutaneous Coronary Intervention']}], 'interventions': [{'name': 'Robotic Assisted Percutaneous Coronary Intervention', 'type': 'PROCEDURE', 'description': 'Robotic Assisted Percutaneous Coronary Intervention', 'armGroupLabels': ['Robotic Assisted Percutaneous Coronary Intervention']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Pedro Lemos, PhD', 'role': 'CONTACT', 'email': 'pedro.lemos@einstein.br', 'phone': '+55 (11) 2151-4306'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Israelita Albert Einstein', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}