Ignite Creation Date:
2025-12-25 @ 12:20 AM
Ignite Modification Date:
2026-01-03 @ 1:07 PM
Study NCT ID:
NCT02693158
Status:
COMPLETED
Last Update Posted:
2020-06-26
First Post:
2016-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Direct III Post Market Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2021-04-14', 'releaseDate': '2021-03-18'}, {'resetDate': '2023-02-24', 'releaseDate': '2022-05-25'}], 'estimatedResultsFirstSubmitDate': '2021-03-18'}}, '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 440}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-24', 'studyFirstSubmitDate': '2016-02-18', 'studyFirstSubmitQcDate': '2016-02-22', 'lastUpdatePostDateStruct': {'date': '2020-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Target Lesion Failure (TLF)', 'timeFrame': '12 months', 'description': 'Cardiac Death, Target Vessel Myocardial Infarction (TVMI) (Q wave and non-Q wave) or clinically driven Target Lesion Revascularization (TLR) by percutaneous or surgical methods.'}], 'secondaryOutcomes': [{'measure': 'Target Vessel Failure (TVF)', 'timeFrame': 'Discharge, 1, 6 and 12 months', 'description': 'composite endpoint of Cardiac Death, Target Vessel MI, or clinically-driven Target Vessel Revascularization (TVR) by percutaneous or surgical methods.'}, {'measure': 'Major Adverse Cardiac Event (MACE)', 'timeFrame': 'Discharge, 1, 6 and 12 months', 'description': 'defined as a composite of all deaths, Target Vessel MI (Q wave and non-Q wave), emergent coronary artery bypass grafting surgery (CABG), or clinically-driven repeat Target Lesion Revascularization (TLR) by percutaneous or surgical methods.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'The primary objective of this multicenter, single-arm, observational study is to evaluate the feasibility of a systematic direct stenting strategy with the Svelte SLENDER IDS Sirolimus-Eluting Coronary Stent-on-a-Wire Integrated Delivery System (SLENDER IDS) in an all-comers, real-world population.', 'detailedDescription': 'In this post-market study, the population will include real-world subjects who are intended to be treated, with SLENDER IDS as standard therapy. Follow-up contacts post procedure will be made for clinical assessments at hospital discharge, 1, 6 and 12 months.\n\nThis study is designed as a prospective, multi-center, single-arm, observational all-comers clinical study to collect ongoing safety and efficacy of SLENDER IDS and to determine the feasibility of a direct stenting strategy in an all-comers population. A minimum of two hundred fifty (250) subjects will be treated at up to 20 sites in Europe.\n\nReview of safety data and risks to subjects will be monitored by an independent Clinical Events Committee (CEC) at pre-specified enrollment milestones.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study is designed as a prospective, multi-center, single-arm, observational all-comers clinical study to collect ongoing safety and efficacy of SLENDER IDS and to determine the feasibility of a direct stenting strategy in an all-comers population.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subject is ≥ 18 years old;\n2. Subject has symptomatic heart disease due to coronary artery lesions of length \\< 28 mm and a reference vessel diameter 2.5 - 4.0 mm.\n3. Subject is intended to be treated with PCI and implantation of SLENDER IDS as part of his/her standard treatment\n4. Subject or subject's legal representative understands the study requirements and the treatment procedures and provides written informed consent before any study specific tests or procedures are performed.\n\nExclusion Criteria:\n\n1. Subject is unable to receive anti-platelet and/or anti-coagulant therapy;\n2. Subject is allergic to sirolimus, PEA III Ac Bz, cobalt, chromium, nickel or tungsten;\n3. The subject is judged to have lesions preventing complete inflation of an angioplasty balloon or proper placement of a coronary stent, including chronic total occlusions.\n4. Subject is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential, based on the standard of care for the cath lab);\n5. Subject is participating in another investigational drug or device clinical trial that the investigator feels would interfere with the subject's participation in this study."}, 'identificationModule': {'nctId': 'NCT02693158', 'acronym': 'Direct III', 'briefTitle': 'The Direct III Post Market Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Svelte Medical Systems, Inc.'}, 'officialTitle': 'Direct Implantation of Sirolimus-Eluting Stents With Bioresorbable Drug Carrier Technology Utilizing the Svelte Drug-Eluting Coronary Stent: The Direct III Post Market Study', 'orgStudyIdInfo': {'id': 'IP-15-002'}}, 'contactsLocationsModule': {'locations': [{'city': 'Amersfoort', 'country': 'Netherlands', 'facility': 'Meander Medical Center', 'geoPoint': {'lat': 52.155, 'lon': 5.3875}}, {'zip': '1091 AC', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'OLVG', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '1261AN', 'city': 'Blaricum', 'country': 'Netherlands', 'facility': 'Tergooi Hospital', 'geoPoint': {'lat': 52.2725, 'lon': 5.24167}}, {'zip': '4819 EV', 'city': 'Breda', 'country': 'Netherlands', 'facility': 'Amphia Ziekenhuis', 'geoPoint': {'lat': 51.58656, 'lon': 4.77596}}, {'zip': '3300 AK', 'city': 'Dordrecht', 'country': 'Netherlands', 'facility': 'Albert Schweitzer Hospital', 'geoPoint': {'lat': 51.81, 'lon': 4.67361}}, {'zip': '3430 EM', 'city': 'Nieuwegein', 'country': 'Netherlands', 'facility': 'St Antonius Hospital', 'geoPoint': {'lat': 52.02917, 'lon': 5.08056}}, {'zip': '2545 AA', 'city': 'The Hague', 'country': 'Netherlands', 'facility': 'HagaZiekenhuis', 'geoPoint': {'lat': 52.07667, 'lon': 4.29861}}, {'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'University Medical Center', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}], 'overallOfficials': [{'name': 'Dennis Donohoe, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Svelte Medical'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Svelte Medical Systems, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2021-03-18', 'type': 'RELEASE'}, {'date': '2021-04-14', 'type': 'RESET'}, {'date': '2022-05-25', 'type': 'RELEASE'}, {'date': '2023-02-24', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Svelte Medical Systems, Inc.'}}}}