Percutaneous Coronary Intervention Clinical Trial
Official title:
A Prospective, Open Label, Multi-center Trial of Firehawk™ Coronary Stent System in the Treatment of Coronary Chronic Total Occlusion Lesion(s) by Optical Coherent Tomography (OCT) and Coronary Angiography
Verified date | January 2020 |
Source | Shanghai MicroPort Medical (Group) Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is a prospective, multi-center, open-label, randomized controlled clinical trial,aims to assess the safety and effectiveness of the Firehawk™ sirolimus target-eluting coronary stent system with abluminal grooves containing a biodegradable polymer (Firehawk™) comparing the XIENCE everolimus-eluting coronary stent system in the treatment of subjects with total coronary occlusion lesion(s).
Status | Active, not recruiting |
Enrollment | 196 |
Est. completion date | October 2023 |
Est. primary completion date | September 16, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Clinical Inclusion Criteria: - CI1. Subject must be at least 18 years of age; - CI2. Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed; - CI3. Subject is eligible for percutaneous coronary intervention (PCI); - CI4. Subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia; - CI5. Subjects are eligible candidates for coronary artery bypass graft surgery (CABG); - CI6. Left ventricular ejection fraction (LVEF) within 60 days = 35%; Exclusion Criteria; - CI7. Subject is willing to comply with all protocol-required follow-up evaluation. Angiographic Inclusion Criteria (visual estimate): - AI1. Target lesions must be new and have a visually estimated reference diameter =2.25 mm and =4.0 mm in autologous coronary artery; - AI2. Target lesions must be < 100 mm in length (visual estimate) and the number of implanted stents is less than 4; - AI3. Target lesions must be visually complete occlusion and longer than 4 weeks; - AI4. Target lesions must be able to pass and be successfully expanded; Clinical Exclusion Criteria: - CE1. Subjects recently suffer from MI (within 1 week), and ECG changes/clinical symptoms consistent with AMI or accompanied with increased cardiac biomarkers (CK-MB, CK, TNT or TNI) are excluded; - CE2. Subjects had an organ transplant or are waiting for an organ transplant; - CE3. Subjects are receiving chemotherapy or will receive a chemotherapy within 30 days after PCI; - CE4. Subjects are undergoing chronic (over 72 hours) anticoagulant therapy (such as heparin and coumarin) other than acute coronary syndrome; - CE5. Subjects with abnormal counts of platelet and white blood cell (WBC): platelet counts less than 100×10E9/L or greater than 700×10E9/L, white blood cells less than 3×10E9/L; - CE6. Subjects have confirmed or suspected liver disease, including hepatitis lab results; - CE7. Subjects with elevated serum creatinine level >3.0mg/dL or undergoing dialysis therapy; - CE8. Subjects with active peptic ulcer, active gastrointestinal (GI) bleeding or other bleeding diathesis or coagulopathy, or refused a blood transfusion; - CE9. Subjects with cerebral vascular accident (CVA) or transient ischemic attack (TIA) in the past 6 months, or with permanent nerve defects; - CE10. Subjects had any PCI (such as balloon angioplasty, stent, cutting balloon,atherectomy) treatment in target vessels (including collateral) within 12 months prior to baseline; - CE11. Subjects plan to undergo PCI or CABG after the baseline PCI; - CE12. Subjects have any coronary endovascular brachytherapy treatment previously; - CE13. Subjects associated with drugs allergy (such as sirolimus, or structure-related compounds fluorinated polymers, thiophenepyridine or aspirin); - CE14. Subjects are suffering from other serious illness (such as cancer, congestive heart failure), which may cause drop in life expectancy to less than 18 months; - CE15. Subjects are currently abusing drugs (such as alcohol, cocaine, heroin, etc); - CE16. Subject plan to undergo any operations that may lead to confuse with the programme; - CE17. Subjects were participating in another study of drug or medical device which did not meet its primary endpoint; - CE18. Subjects plan to pregnant within 18 months after baseline; - CE19. Subjects are pregnant or breastfeeding women. Angiographic Exclusion Criteria (visual estimate): - AE1. Target lesions with the following criteria: left main, saphenous vein grafts or arterial grafts, via saphenous vein grafts or arterial graft, and in-stent stenosis; - AE2. Subjects with unprotected left main coronary artery disease (diameter stenosis >50%); - AE3. Subjects have a protected left main coronary artery disease (diameter stenosis> 50% and left coronary artery bypass surgery), as well as target lesions located in the LAD and LCX; - AE4. Subjects with other lesions of clinical significance, may be need intervention within 18 months after baseline. |
Country | Name | City | State |
---|---|---|---|
China | The General Hospital of Shenyang Military | Shenyang | Liaoning |
Lead Sponsor | Collaborator |
---|---|
Shanghai MicroPort Medical (Group) Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Target Vessel Failure (TVF) | During hospitalization and 30 days, 3 months, 6 months, 12 months and 2-5 years post-index procedure. | ||
Other | Target Lesion Failure (TLF) | During hospitalization and 30 days, 3 months, 6 months, 12 months and 2-5 years post-index procedure. | ||
Other | Target Vessel Revascularization (TVR) | During hospitalization and 30 days, 3 months, 6 months, 12 months and 2-5 years post-index procedure. | ||
Other | Target Lesion Revascularization (TLR) | During hospitalization and 30 days, 3 months, 6 months, 12 months and 2-5 years post-index procedure. | ||
Other | Myocardial Infarction (MI,including Q-wave MI and non Q-wave MI) | During hospitalization and 30 days, 3 months, 6 months, 12 months and 2-5 years post-index procedure. | ||
Other | Death (All cause, Cardiac, Non-cardiac) | During hospitalization and 30 days, 3 months, 6 months, 12 months and 2-5 years post-index procedure. | ||
Other | Cardiac Death/ All Myocardial Infarction | During hospitalization and 30 days, 3 months, 6 months, 12 months and 2-5 years post-index procedure. | ||
Other | Stent Thrombosis (per ARC definition) | During hospitalization and 30 days, 3 months, 6 months, 12 months and 2-5 years post-index procedure. | ||
Other | In-stent and in-segment percent diameter stenosis (DS%) | At 12 months post-index procedure. | ||
Other | In-segment late lumen loss | At 12 months post-index procedure. | ||
Other | In-stent and in-segment minimum lumen diameter (MLD) | At 12 months post-index procedure. | ||
Other | In-stent and in-segment binary restenosis rate (%) | At 12 months post-index procedure. | ||
Other | Mean/Minimal Stent area (mm2) | At 3 months and 12 months post-index procedure. | ||
Other | Mean/Minimal Lumen area (mm2) | At 3 months and 12 months post-index procedure. | ||
Other | Lumen volume (mm3) | At 3 months and 12 months post-index procedure. | ||
Other | Stent volume (mm3) | At 3 months and 12 months post-index procedure. | ||
Other | Mean neointimal hyperplasia area (mm2) | At 3 months and 12 months post-index procedure. | ||
Other | In-stent neointimal hyperplasia volume obstruction (%) | At 3 months and 12 months post-index procedure. | ||
Other | Uncovered strut rate (%) | At 3 months and 12 months post-index procedure. | ||
Other | Malapposed strut rate (%) | At 3 months and 12 months post-index procedure. | ||
Other | Malposed and uncovered strut rate (%) | At 3 months and 12 months post-index procedure. | ||
Other | Technical success rate | Instantly after index procedure. | ||
Other | Clinical procedural success rate | At time of procedure up to 7 days in hospital. | ||
Primary | In-stent late lumen loss | At 12 months post-index procedure | ||
Secondary | Neo-intimal thickness by Optical Coherence Tomography (OCT) | At 3 months post-index procedure |
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