Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2026-02-19 @ 7:56 AM
Study NCT ID:
NCT03616132
Status:
UNKNOWN
Last Update Posted:
2018-08-06
First Post:
2018-07-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A First-in-Man Study to Evaluate the Feasibility and Safety of Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, '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': 15}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2023-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-03', 'studyFirstSubmitDate': '2018-07-30', 'studyFirstSubmitQcDate': '2018-08-03', 'lastUpdatePostDateStruct': {'date': '2018-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Study Device related Composite Endpoint (Target Lesion Failure)', 'timeFrame': '1 month after implantation', 'description': 'Target Lesion Failure is defined as the composited endpoints of including cardiac death, Target vessel related myocardial infarction (TV-MI) and clinical indicated target lesion revascularization (CI-TLR), also known as MACE (major adverse cardiac events).'}], 'secondaryOutcomes': [{'measure': 'Immediate Success Rate', 'timeFrame': 'Immediate postoperative', 'description': '1. Device Success:\n\n Successfully transit and release the IBS at target lesion, then withdraw the delivery system. Immediate residual stenosis \\< 30% and TIMI blood flow is class 3 (visual).\n2. Lesion Success: Any method of intervention therapy, the residual stenosis of the target lesion \\< 30% and TIMI blood flow is class 3(visual).'}, {'measure': 'Clinical Success', 'timeFrame': 'Hospitalized period postoperative within 7 days', 'description': 'Defined as based on lesion success, there is no major adverse cardiac events in the hospitalization period.'}, {'measure': 'Performance Evaluation of IBS', 'timeFrame': 'Immediate postoperative', 'description': '4 class (Excellent, good, general, bad) to evaluate the push ability, performance of through the lesions, performance of cover the lesions, support force, withdraw ability.'}, {'measure': 'Device related Composite Endpoint (DoCE)', 'timeFrame': '6 Month, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years postprocedure', 'description': 'Target Lesion Failure, defined as the composited endpoints of including cardiac death, Target vessel related myocardial infarction (TV-MI) and clinical indicated target lesion revascularization (CI-TLR), also known as MACE (major adverse cardiac events).'}, {'measure': 'Patient related Clinical Composite Endpoint (PoCE)', 'timeFrame': '30 Days, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years postprocedure', 'description': 'Including all-cause mortality, all myocardial infarction and target lesion revascularization.'}, {'measure': 'Stent Thrombosis defined by ARC', 'timeFrame': 'Acute(0-24 hours), Subacute(24 hours-30 days), Late(30 days-1 year),Very late(after 1 year)', 'description': 'Timing (acute, sub-acute, late and very late) Evidence (definite and probable)'}, {'measure': 'Acute stent retraction', 'timeFrame': 'Immediate postoperative', 'description': 'Angiographic Endpoint'}, {'measure': 'In-stent, in-segment, proximal and distal minimum lumen diameter (MLD)', 'timeFrame': 'Immediate postoperative, 1 year, 3 years', 'description': 'Angiographic Endpoint'}, {'measure': 'In-stent, in-segment, proximal and distal Diameter stenosis(DS)', 'timeFrame': '1 year, 3 years', 'description': 'Angiographic Endpoint'}, {'measure': 'In-stent, in-segment, proximal and distal Late lumen loss (LLL)', 'timeFrame': '1 year, 3 years', 'description': 'Angiographic Endpoint'}, {'measure': 'In-stent, in-segment, proximal and distal Angiographic defined restenosis (ABR)', 'timeFrame': '1 year, 3 years', 'description': 'Angiographic Endpoint'}, {'measure': 'Vasomotion', 'timeFrame': '1 year, 3 years', 'description': 'Defined as the average diameter change of lumen diameter before and after using nitroglycerin.'}, {'measure': 'Analysis of Morphometric, lesion composition and scaffold strut data obtained with OCT', 'timeFrame': ': Immediate postoperative, 1 year, 3 years', 'description': 'Optical Coherence Tomography Endpoint'}, {'measure': 'Analysis of Vascular and scaffold morphology obtained with IVUS', 'timeFrame': 'Immediate postoperative,1 year, 3 years', 'description': 'Intra-Vascular Ultrasound Endpoint'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Single Coronary Vessel Disease']}, 'descriptionModule': {'briefSummary': 'The study is a pilot clinical trial for Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System（IBS）. The main purpose of this study is to evaluate the feasibility, preliminary safety and efficacy of IBS. To provide the basis for subsequent large-scale, multi-center, randomized controlled clinical trials of IBS.', 'detailedDescription': '* A prospective, non-randomized trial\n* Study population: 15 patients\n* Clinical follow up will be required at postoperative, 1 month, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years;\n* All the subjects perform the angiography, Intra-vascular ultrasound (IVUS) and Optical coherence tomography (OCT) at 1 year and 3 years.\n* The primary study endpoint is target lesion failure (TLF) at 1 month post procedure; and imaging findings as the secondary study endpoint. To evaluate the feasibility, safety and performance of IBS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* All patients participating in this clinical trial must meet the following criteria:\n\n 1. Age of 18-75， males or non pregnancy females;\n 2. Subject must have evidence of myocardial ischemia (e.g., stable, unstable angina, post-infarct angina or silent ischemia) suitable for elective PCI;\n 3. One target lesion, and target lesion can be completely covered by a single stent;\n 4. Target lesion length ≤ 18 mm, target lesion diameter between 3.0 mm to 3.5 mm (visual);\n 5. Visual assessment of target lesion stenosis ≥70%, TIMI blood flow≥ 1;\n 6. Subject who understand the purpose of testing, voluntary and informed consent, patients undergoing invasive imaging follow-up.\n\nExclusion Criteria:\n\n* Patients will be excluded if any of the following conditions apply:\n\nGeneral:\n\n1. Within 1 week of any acute myocardial infarction or myocardial enzymes did not return to normal;\n2. Implantation of stent in target vessel within 1 year , patients with planned intervention again within six months;\n3. Patients who performed coronary artery bypass (coronary artery bypass grafting);\n4. Patients with contraindications for coronary artery bypass graft surgery;\n5. Severe heart failure (NYHA class III and above) or left ventricular ejection fraction\\<40% (ultrasonic or left ventricular angiography);\n6. Preoperative renal function: serum creatinine \\> 2.0 mg/dl or 177 mu mol/L; receiving hemodialysis;\n7. Patients have ischemic stroke half a year before implantation, patients have transient ischemic attack 3 months before implantation, patients have high coagulation tendency judged by investigator or laboratory examination;\n8. Bleeding, active gastrointestinal ulcers, brain hemorrhage or subarachnoid hemorrhage, contraindications on antiplatelet agents and anticoagulant therapy; patients would not allow to undergoing antithrombotic therapy;\n9. Aspirin, clopidogrel, heparin, contrast agent, poly lactic acid polymer, rapamycin and metal allergies;\n10. Patients who have a history of disease related to iron overload or iron disorder, such as hereditary hemochromatosis, etc;\n11. The patient's life expectancy is less than 12 months;\n12. Patient participated in other drug or medical device study and does not meet the primary study endpoint in clinical trials time frame;\n13. Poor compliance and patients unable to complete the study in accordance with the requirements;\n14. Patient with heart transplant;\n15. The unstable arrhythmia, such as high risk ventricular extra systole and ventricular tachycardia;\n16. Cancer needs chemotherapy;\n17. Patients of immune suppression, autoimmune diseases, planned or undergoing immunosuppressive therapy;\n18. Planning or being receiving long-term anticoagulant therapy, such as heparin, warfarin, etc;\n19. With six months for elective surgery requires stop using aspirin and clopidogrel;\n20. Blood test prompted platelet count \\< 100 x 109/L, or \\> 700 x 109/L, white blood cells \\< 3 x 109/L, or abnormal liver function (ALT、AST 3 times greater than normal range);\n21. Patients with diffuse peripheral vascular disease; cannot use 6F catheter;\n22. Patients with valvular surgery in the past.\n\nExclusion criteria by angiography:\n\n1. Chronic total occlusion (TIMI blood flow=0 before implantation) , left main coronary artery lesion, ostial lesion, multiple vessel lesion, branch lesion and bridge lesion which branch vessel diameter ≥ 2.0 mm (if the ostium of branch vessel stenosis \\>40% or needs balloon predilation); visible thrombus in target vessels;\n2. Severe calcified lesions and distorted disease which unable to predilation, lesion not suitable for stent delivery and expansion;\n3. In-stent restenosis;\n4. Myocardial bridge is involved in target lesion;\n5. In order to reach the target lesion, study stent has to go through the previous implanted stent;\n6. Predilation balloon can't expand completely in target lesion site, judgment standard for fully expansion as below, patients are excluded when do not meet any item:\n\nA. DS% \\< 40%（visual），highly recommend DS% ≤20% B. TIMI blood flow= class 3（visual） C. No angiography complications (e.g., distal embolization, lateral branch closed) D. No interlining level NHLBI type D - F E. No continuous chest pain (\\> 5 minutes), and F. No lower or higher ST segment \\>5 minutes."}, 'identificationModule': {'nctId': 'NCT03616132', 'briefTitle': 'A First-in-Man Study to Evaluate the Feasibility and Safety of Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lifetech Scientific (Shenzhen) Co., Ltd.'}, 'officialTitle': 'A Prospective, Non-randomized, Open-label, Non-comparative, First-in-Man Study to Evaluate the Feasibility and Safety of Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System', 'orgStudyIdInfo': {'id': 'IBS-FIM-MY'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IBS implantation', 'description': 'Implantation of IBS in patients with coronary artery lesions.', 'interventionNames': ['Device: Device: Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System']}], 'interventions': [{'name': 'Device: Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System', 'type': 'DEVICE', 'description': 'Implantation of Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System (IBS)', 'armGroupLabels': ['IBS implantation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kuala Lumpur', 'state': 'Negeri Selangor', 'status': 'NOT_YET_RECRUITING', 'country': 'Malaysia', 'contacts': [{'name': 'Jamauddin Bin Yahaya Shaiful Azmi', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institut Jantung Negara', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}, {'city': 'Kuala Lumpur', 'state': 'Negeri Selangor', 'status': 'RECRUITING', 'country': 'Malaysia', 'contacts': [{'name': 'Azman Wan Ahmad Wan', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Malaya Medical Centre', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}], 'centralContacts': [{'name': 'Ying Xia', 'role': 'CONTACT', 'email': 'xiaying@lifetechmed.com', 'phone': '+86 13760184511'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lifetech Scientific (Shenzhen) Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}