Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2026-02-20 @ 6:34 PM
Study NCT ID:
NCT03716102
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2020-06-26
First Post:
2018-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
OPTIMIZE Sirolimus-Eluting Coronary Stent Systems Pharmacokinetics (PK) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2022-11-18', 'mcpReleaseN': 5, 'releaseDate': '2022-10-27'}], 'estimatedResultsFirstSubmitDate': '2022-10-27'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], 'ancestors': [{'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single Group Assignment'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-11-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2021-07-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-24', 'studyFirstSubmitDate': '2018-10-18', 'studyFirstSubmitQcDate': '2018-10-19', 'lastUpdatePostDateStruct': {'date': '2020-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum observed blood concentration (Cmax)', 'timeFrame': 'Up to 30 days'}, {'measure': 'Time to reach maximum blood concentration (tmax)', 'timeFrame': 'Up to 30 days'}, {'measure': 'Area under the blood concentration versus time curve: time zero to the final quantifiable concentration) (AUC 0-t)', 'timeFrame': 'Up to 30 days'}, {'measure': 'Area under the blood concentration versus time curve: time zero to the extrapolated infinite time (AUC 0-∞)', 'timeFrame': 'Up to 30 days'}, {'measure': 'Terminal phase half-life (t1/2)', 'timeFrame': 'Up to 30 days'}, {'measure': 'Apparent total blood clearance (CL/F)', 'timeFrame': 'Up to 30 days'}, {'measure': 'Apparent volume of distribution (Vd/F)', 'timeFrame': 'Up to 30 days'}], 'secondaryOutcomes': [{'measure': 'Target Vessel Failure (TVF)', 'timeFrame': '6 months, 12 months, 2 years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Acute Coronary Syndrome']}, 'descriptionModule': {'briefSummary': 'To evaluate the pharmacokinetic parameters of sirolimus release from the Svelte DES.', 'detailedDescription': 'This is a prospective, open, non-randomized, study involving two (2) centers in the United States. A minimum of twelve (12) and a maximum of fifteen (15) subjects will be consented, treated and have blood samples drawn to evaluate the pharmacokinetic parameters of sirolimus release from the Svelte DES.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject is an eligible candidate for PCI\n* Subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia\n* Subject is an acceptable candidate for CABG\n* Subject has ≤ 3 de novo target lesions in ≤ 2 native coronary artery vessels, with ≤ 2 lesions in a single vessel, each meeting the angiographic criteria and none of the exclusion criteria\n* Target lesion(s) must be located in a native coronary artery with RVD ≥ 2.25mm and ≤ 4.00mm\n\nExclusion Criteria:\n\n* Subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmia, or ongoing intractable angina\n* Subject's target lesion(s) is located in the left main coronary artery\n* Subject's target lesion(s) is located within 3mm of the origin of the LAD or LCX coronary artery\n* Subject's target lesion(s) is located within a SVG or an arterial graft\n* Subject's target lesion(s) will be accessed via SVG or arterial graft"}, 'identificationModule': {'nctId': 'NCT03716102', 'briefTitle': 'OPTIMIZE Sirolimus-Eluting Coronary Stent Systems Pharmacokinetics (PK) Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Svelte Medical Systems, Inc.'}, 'officialTitle': 'OPTIMIZE Sirolimus-Eluting Coronary Stent Systems Pharmacokinetics (PK) Study', 'orgStudyIdInfo': {'id': 'IP-18-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Svelte DES', 'description': 'Stent: A mounted Cobalt Chromium (Co-Cr) alloy based stent Polymer coating: Polyesteramide (PEA) Sirolimus drug', 'interventionNames': ['Device: PCI with implantation with DES']}], 'interventions': [{'name': 'PCI with implantation with DES', 'type': 'DEVICE', 'description': 'PCI with implantation with DES', 'armGroupLabels': ['Svelte DES']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Scottsdale Healthcare', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '49770', 'city': 'Petoskey', 'state': 'Michigan', 'country': 'United States', 'facility': 'Northern Michigan Hospital d.b.a McLaren Northern Michigan', 'geoPoint': {'lat': 45.37334, 'lon': -84.95533}}], 'overallOfficials': [{'name': 'Dennis Donohoe, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Svelte Medical Systems'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Svelte Medical Systems, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}