Percutaneous Coronary Intervention Clinical Trial
Official title:
A Prospective Multi-center Open-label Controlled Trial of Comparison 3 vs 12 Months of Dual Anti-Platelet Therapy After Implantation of Firehawk Sirolimus Target- Eluting Stent in Patients With Stable Coronary Artery Disease
This study is a prospective,multi-center, open-label, randomized controlled clinical trial,aims to assess the clinical noninferiority of 3 months (short-term) vs 12 months (long-term) of Dual Anti-Platelet Therapy (DAPT) in patients undergoing percutaneous coronary intervention implanted sirolimus target- eluting stent with abluminal grooves containing a biodegradable polymer (Firehawk™ stent). All participants met the inclusion criteria begin taking aspirin and open-label thienopyridine therapy before index procedure, and will be 1:1 randomized to 3 months or 12 month of DAPT at index procedure.
Status | Recruiting |
Enrollment | 2446 |
Est. completion date | October 2022 |
Est. primary completion date | December 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
General Inclusion Criteria: - Age = 18 years; - Subjects (or legal guardians) understand the testing requirements and procedures, and provide written informed consent; - Subjects with symptomatic coronary artery disease or confirmed asymptomatic ischemia; - Target lesion should be new lesion with visually estimated reference diameter =2.5 mm and =4.0 mm in autologous coronary artery; - Subjects willing to accept PCI therapy and to implant Firehawk™ stent only; - Left ventricular ejection fraction (LVEF) = 30%; - Subjects willing to accept the trial plan calls for all subsequent evaluations. Angiographic Inclusion Criteria: - Target lesions must be new and have a visually estimated reference diameter =2.5 mm and =4.0 mm in autologous coronary artery; - No limitations in target lesion length and number; - The first target lesion must be able to successfully expand and implant Firehawk™ stent. Clinical Exclusion Criteria: - Subjects with ST-segment elevation myocardial infarction: - Subjects having an organ transplant or waiting for an organ transplant - Subjects receiving chemotherapy or going to receive a chemotherapy within 30 days after PCI - Subjects undergoing chronic (over 72 hours) anticoagulant therapy (such as heparin and coumarin) other than acute coronary syndrome - Subjects with abnormal counts of platelet and white blood cell (WBC) (investigator assess clinical significance combine normal reference range of laboratory) - Subjects with confirmed or suspected liver disease, including hepatitis lab results - Subjects with elevated serum creatinine level >3.0mg/dL or undergoing dialysis therapy - Subjects with active peptic ulcer, active gastrointestinal (GI) bleeding or other bleeding diathesis or coagulopathy, or refused a blood transfusion - Subjects with cerebral vascular accident (CVA) or transient ischemic attack (TIA) in the past 6 months, or with permanent nerve defects - Subjects undergoing any PCI treatment in target vessels within 12 months prior to baseline - Subjects planned to undergo PCI or CABG within 18 months after the baseline PCI - Subjects with a history of any coronary endovascular brachytherapy treatment previously - Subjects associated with drugs allergy (such as sirolimus, or structure-related compounds fluorinated polymers, thienopyridine or aspirin) - Subjects being suffered from other serious illness (such as cancer, congestive heart failure), which may cause drop in life expectancy to less than 18 months - Subjects with a history of drug abuse (such as alcohol, cocaine, heroin, etc.) - Subject planned to undergo any operations that may lead to confuse with the programme - Subjects participating in another study of drug or medical device which did not meet its primary endpoint - Subjects planned to pregnant within 18 months after baseline - Pregnant or breastfeeding women Angiographic Exclusion Criteria: - Target lesions with the following criteria: left main, saphenous vein grafts or arterial grafts, via saphenous vein grafts or arterial graft, and in-stent restenosis; - Subjects with unprotected left main coronary artery disease (diameter stenosis >50%); - Protected left main coronary artery disease(diameter stenosis >50% and undergoing CABG)with target lesions located in left anterior descending artery and left circumflex artery; - Additional lesions of clinical significance possibly needing interventional within 18 months after enrollment.. |
Country | Name | City | State |
---|---|---|---|
China | Shanghai Zhongshan Hospital | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai MicroPort Medical (Group) Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Net Adverse Clinical and Cerebral Events (NACCE) | In hospital and at 30 days, 3, 6, 12, 24 and 36 months after index procedure. | ||
Other | Major Adverse Cardiac and Cerebral Events (MACCE) | In hospital and at 30 days, 3, 6, 12 ,18, 24 and 36 months after index procedure. | ||
Other | Stent Thrombosis (per ARC definition) | the definite and probable stent thrombosis | In hospital and at 30 days, 3, 6, 12 ,18, 24 and 36 months after index procedure. | |
Other | Target Vessel Revascularization (TVR) | In hospital and at 30 days, 3, 6, 12 ,18, 24 and 36 months after index procedure. | ||
Other | Target Lesion Revascularization (TLR) | In hospital and at 30 days, 3, 6, 12 ,18, 24 and 36 months after index procedure. | ||
Other | Target Vessel Failure (TVF) | In hospital and at 30 days, 3, 6, 12 ,18, 24 and 36 months after index procedure. | ||
Other | Target Lesion Failure (TLF) | In hospital and at 30 days, 3, 6, 12 ,18, 24 and 36 months after index procedure. | ||
Other | Myocardial Infarction (MI,including Q-wave MI and non Q-wave MI) | In hospital and at 30 days, 3, 6, 12 ,18, 24 and 36 months after index procedure. | ||
Other | Major bleeding (ARC definition and GUSTO definition) | In hospital and at 30 days, 3, 6, 12 ,18, 24 and 36 months after index procedure. | ||
Other | Death (All cause, Cardiac, Non-cardiac) | In hospital and at 30 days, 3, 6, 12 ,18, 24 and 36 months after index procedure. | ||
Other | Cardiac Death/ All Myocardial Infarction | In hospital and at 30 days, 3, 6, 12 ,18, 24 and 36 months after index procedure. | ||
Other | Procedural Success | At time of procedure up to 7 days in hospital | ||
Other | Minimal Lumen Diameter (MLD)(In-device, in-segment, proximal 5 mm and distal 5 mm) | Instantly after index procedure | ||
Other | The Immediate Lumen Gain | Instantly after index procedure | ||
Primary | Net Adverse Clinical and Cerebral Events (NACCE) | A composite of all-cause death, MI, cerebral vascular accident (CVA) and major bleeding at 18 months | At 18 months after index procedure | |
Secondary | Cost-Effectiveness Ratio (CER) | CER = [total medical care costs of anti-platelet therapy] / [number of participants without net adverse clinical and cerebral events (NACCE)] | At 18 months after index procedure |
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