Ignite Creation Date:
2025-12-26 @ 1:19 PM
Ignite Modification Date:
2026-02-26 @ 5:44 PM
Study NCT ID:
NCT02086006
Status:
COMPLETED
Last Update Posted:
2023-09-07
First Post:
2014-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Elixir Medical Clinical Evaluation of the DESolve Myolimus Eluting Bioresorbable Coronary Stent System - DESolve I Trial
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': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-05', 'studyFirstSubmitDate': '2014-03-10', 'studyFirstSubmitQcDate': '2014-03-11', 'lastUpdatePostDateStruct': {'date': '2023-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-03-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinically-Indicated Major Adverse Cardiac Event (CI-MACE)', 'timeFrame': '1 month'}, {'measure': 'Clinically-Indicated Target Lesion Failure (CI-TLF)', 'timeFrame': '1 month'}, {'measure': 'Clinically-Indicated Target Vessel Failure (CI-TVF)', 'timeFrame': '1 month'}, {'measure': 'Clinically-Indicated Target Vessel Revascularization (CI-TVR)', 'timeFrame': '1 month'}, {'measure': 'Stent thrombosis', 'timeFrame': '1 month'}, {'measure': 'Acute success - Procedure success', 'timeFrame': '7 days', 'description': 'Acute Success is classified according to the following definitions:\n\nProcedure success - Attainment of final result, \\< 50% residual stenosis of the target site, using the DESolve Myolimus Eluting BCSS device without the occurrence of in-hospital any Major Adverse Cardiac Endpoints.'}, {'measure': 'Acute success - Device success', 'timeFrame': '7 days', 'description': 'Acute Success is classified according to the following definitions:\n\nDevice success - Attainment of final result, \\< 50% residual stenosis of the target site, using the study stent without the need for other non-study stents.'}, {'measure': 'Stent thrombosis', 'timeFrame': '6 months'}, {'measure': 'Stent thrombosis', 'timeFrame': '12 months'}, {'measure': 'Stent thrombosis', 'timeFrame': '2 years'}, {'measure': 'Stent thrombosis', 'timeFrame': '3 years'}, {'measure': 'Stent thrombosis', 'timeFrame': '4 years'}, {'measure': 'Stent thrombosis', 'timeFrame': '5 years'}, {'measure': 'Clinically-Indicated Major Adverse Cardiac Event (CI-MACE)', 'timeFrame': '6 months'}, {'measure': 'Clinically-Indicated Major Adverse Cardiac Event (CI-MACE)', 'timeFrame': '12 months'}, {'measure': 'Clinically-Indicated Major Adverse Cardiac Event (CI-MACE)', 'timeFrame': '2 years'}, {'measure': 'Clinically-Indicated Major Adverse Cardiac Event (CI-MACE)', 'timeFrame': '3 years'}, {'measure': 'Clinically-Indicated Major Adverse Cardiac Event (CI-MACE)', 'timeFrame': '4 years'}, {'measure': 'Clinically-Indicated Major Adverse Cardiac Event (CI-MACE)', 'timeFrame': '5 years'}, {'measure': 'Clinically-Indicated Target Lesion Failure (CI-TLF)', 'timeFrame': '6 months'}, {'measure': 'Clinically-Indicated Target Lesion Failure (CI-TLF)', 'timeFrame': '12 months'}, {'measure': 'Clinically-Indicated Target Lesion Failure (CI-TLF)', 'timeFrame': '2 years'}, {'measure': 'Clinically-Indicated Target Lesion Failure (CI-TLF)', 'timeFrame': '3 years'}, {'measure': 'Clinically-Indicated Target Lesion Failure (CI-TLF)', 'timeFrame': '4 years'}, {'measure': 'Clinically-Indicated Target Lesion Failure (CI-TLF)', 'timeFrame': '5 years'}, {'measure': 'Clinically-Indicated Target Vessel Failure (CI-TVF)', 'timeFrame': '6 months'}, {'measure': 'Clinically-Indicated Target Vessel Failure (CI-TVF)', 'timeFrame': '12 months'}, {'measure': 'Clinically-Indicated Target Vessel Failure (CI-TVF)', 'timeFrame': '2 years'}, {'measure': 'Clinically-Indicated Target Vessel Failure (CI-TVF)', 'timeFrame': '3 years'}, {'measure': 'Clinically-Indicated Target Vessel Failure (CI-TVF)', 'timeFrame': '4 years'}, {'measure': 'Clinically-Indicated Target Vessel Failure (CI-TVF)', 'timeFrame': '5 years'}, {'measure': 'Clinically-Indicated Target Vessel Revascularization (CI-TVR)', 'timeFrame': '6 months'}, {'measure': 'Clinically-Indicated Target Vessel Revascularization (CI-TVR)', 'timeFrame': '12 months'}, {'measure': 'Clinically-Indicated Target Vessel Revascularization (CI-TVR)', 'timeFrame': '2 years'}, {'measure': 'Clinically-Indicated Target Vessel Revascularization (CI-TVR)', 'timeFrame': '3 years'}, {'measure': 'Clinically-Indicated Target Vessel Revascularization (CI-TVR)', 'timeFrame': '4 years'}, {'measure': 'Clinically-Indicated Target Vessel Revascularization (CI-TVR)', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Coronary artery disease'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'This prospective, consecutive enrolment, single-arm study will enroll up to 15 patients with single de novo, Type A lesions \\< 10 mm in length and located in a native coronary artery with a reference vessel diameter of 2.75 mm - 3.0 mm as measured by both offline QCA and IVUS. All patients will receive a 3.0 x 14mm DESolve Stent loaded with approximately 40 mcg of Myolimus.\n\n* Angiographic and intravascular ultrasound (IVUS) will be completed for all patients at baseline and at 6 months.\n* Optical Coherence Tomography (OCT) will will be completed for all patients at baseline and at 6 months.\n* Multi-slice computed tomography (MSCT) will be conducted on all patients enrolled at 12 and 24 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient must be at least 18 years of age\n* Patient is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the DESolve Myolimus Eluting BCSS and he/she or his/her legally authorized representative provides written informed consent, as approved by the appropriate Ethics Committee of the respective clinical site, prior to any clinical study related procedure\n* Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study electrocardiogram (ECG) changes consistent with ischemia)\n* Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery\n* Patient must agree to undergo all clinical study required follow-up visits, angiograms, IVUS, OCT and MSCT\n* Patient must agree not to participate in any other clinical study for a period of two years following the index procedure\n\nExclusion Criteria:\n\n* Patients has a known diagnosis of acute myocardial infarction (AMI) within 72 hours preceding the index procedure and CK and CK-MB have not returned within normal limits at the time of procedure\n* The patient is currently experiencing clinical symptoms consistent with AMI\n* Patient has current unstable arrhythmias Patient has undergone previous percutaneous interventions for lesions in either a non-target vessel or target vessel Patient has undergone previous percutaneous interventions for lesions in either a non-target vessel or target vessel\n* Patient has a known left ventricular ejection fraction (LVEF) \\< 30%\n* Patient has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant\n* Patient is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or after the procedure\n* Patient is receiving immunosuppression therapy and has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.)\n* Patient is receiving or scheduled to receive chronic anticoagulation therapy (e.g., heparin, coumadin)\n* Patient has a known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, both clopidogrel and ticlopidine, Myolimus, PLLA polymers or contrast sensitivity that cannot be adequately pre-medicated\n* Elective surgery is planned within the first 6 months after the procedure that will require discontinuing either aspirin or clopidogrel\n* Patient has a platelet count \\< 100,000 cells/mm3 or \\> 700,000 cells/mm3, a WBC of \\< 3,000 cells/mm3, or documented or suspected liver disease.\n* Patient has known renal insufficiency (e.g., serum creatinine level of more than 2.5 mg/dL, or patient on dialysis)\n* Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions\n* Patient has had a cerebrovascular accident (CVA) or transient ischemic neurological attack (TIA) within the past six months\n* Patient has had a significant GI or urinary bleed within the past six months\n* Patient has extensive peripheral vascular disease that precludes safe 7 French sheath insertion\n* Patient has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the clinical study plan, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year)\n* Patient is already participating in another clinical study\n* Women of childbearing potential who have not undergone surgical sterilization or is not post-menopausal (defined as amenorrheic for at least one year)'}, 'identificationModule': {'nctId': 'NCT02086006', 'briefTitle': 'Elixir Medical Clinical Evaluation of the DESolve Myolimus Eluting Bioresorbable Coronary Stent System - DESolve I Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Elixir Medical Corporation'}, 'officialTitle': 'A NON-RANDOMIZED, CONSECUTIVE ENROLLMENT EVALUATION OF THE DESolveTM MYOLIMUS ELUTING BIORESORBABLE CORONARY STENT SYSTEM IN THE TREATMENT OF PATIENTS WITH DE NOVO NATIVE CORONARY ARTERY LESIONS', 'orgStudyIdInfo': {'id': 'ELX-CL-1002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'DESolve scaffold', 'description': 'DESolve Novolimus Eluting Bioresorbable Coronary Scaffold. test arm, intervention', 'interventionNames': ['Device: DESolve Novolimus Eluting Bioresorbable Coronary Scaffold']}], 'interventions': [{'name': 'DESolve Novolimus Eluting Bioresorbable Coronary Scaffold', 'type': 'DEVICE', 'armGroupLabels': ['DESolve scaffold']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2020', 'city': 'Antwerp', 'country': 'Belgium', 'facility': 'AZ Middelheim Hospital', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'zip': '1023', 'city': 'Auckland', 'country': 'New Zealand', 'facility': 'Auckland City Hospital', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}, {'zip': '1023', 'city': 'Auckland', 'country': 'New Zealand', 'facility': 'Mercy Angiography Unit', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}], 'overallOfficials': [{'name': 'John Ormiston, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Auckland City Hospital and Mercy Angiography Unit'}, {'name': 'Stefan Verheye, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ZNA Middelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Elixir Medical Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}