SPIRIT V: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Coronary Artery Lesions
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 324
- 试验地点
- 28
- 主要终点
- In-stent Late Loss (LL)
研究概览
简要总结
The purpose of this Clinical Evaluation is a continuation in the assessment of the performance of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in the treatment of patients with de novo coronary artery lesions in patients (Diabetic sub-study).
详细描述
The SPIRIT V Clinical Evaluation consists of two concurrent studies,the Diabetic sub-study and the Registry.
The SPIRIT V Diabetic sub-study is a prospective, randomized, active-controlled, single blind, parallel two-arm multi-center study comparing the XIENCE V® EECSS to the TAXUS® Liberté™ in the treatment of diabetic patients with coronary artery lesions who will fulfill the eligibility criteria. Approximately 300 patients will be randomized (2:1) against the TAXUS® Liberté™ coronary stent system. These patients will be recruited in up to 40 selected sites.
The long term safety and efficacy of the XIENCE V EECSS have been demonstrated in the SPIRIT FIRST trial up to 5 years, the SPIRIT II trial up to 4 years, and in the SPIRIT III Randomized Control Trial (RCT) up to 3 years. In addition, these pre-approval studies have shown low rates of Target Vessel Failure and Major Adverse Cardiac Events (MACE) that were observed to plateau or gradually decline after about 1 year and were consistently lower than the comparator arm of each study. This benefit in MACE is sustained for up to 5 years and is also independent of the first year results.
The post approval SPIRIT V study demonstrated that the use of the XIENCE EECSS in complex lesions in a real-world population resulted in 1 year MACE, Stent Thrombosis and Target Lesion Revascularization rates that are comparable to those of the previously mentioned pre-approval studies which included patients with more restricted inclusion / exclusion criteria.
Therefore, based on existing data from these trials, Abbott Vascular has decided to discontinue further follow up in the SPIRIT V Diabetic study after 1 year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •at least 18 years
- •able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the XIENCE V® EECSS and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure, as approved by the appropriate Medical Ethics Committee of the respective clinical site
- •diagnosed with diabetes, as documented by medical history.
- •evidence of myocardial ischemia
- •acceptable candidate for coronary artery bypass grafting (CABG) surgery
- •agree to undergo all clinical investigation plan (CIP)-required follow-up examinations
- •artery morphology and disease is suitable to be optimally treated with a maximum of 4 planned stents
- •maximum of one, de novo, target lesion per native major epicardial vessel or side branch
- •target vessel reference diameter must be between 2.25 mm and 4.0 mm by visual estimate
- •target lesion ≤ 28 mm in length by visual estimate
- •target lesion must be in a major artery or branch with a visually estimated stenosis of > 50% and < 100% and a TIMI flow > 1
排除标准
- •known diagnosis of acute myocardial infarction within 72 hours preceding the index procedure
- •current unstable arrhythmias
- •Left ventricular ejection fraction < 30%
- •received a heart or any other organ transplant or is on a waiting list for any organ transplant
- •receiving or scheduled to receive chemotherapy or radiation therapy within 30 days prior to or after the procedure.
- •receiving immunosuppression therapy or has known immunosuppressive or autoimmune disease
- •known hypersensitivity or contraindication to specific agents
- •elective surgery is planned within the first 9 months after the procedure that will require discontinuing either aspirin or clopidogrel
- •platelet count limits, white blood cell limits or documented or suspected liver disease
- •renal insufficiency
- •history of bleeding diathesis or coagulopathy or will refuse blood transfusions
- •Cerebrovascular accident or transient ischemic attack within the past 6 months
- •significant GI or urinary bleed within the past 6 months
- •history of other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse that may cause non-compliance with the CIP, confound the data interpretation or is associated with a limited life expectancy (i.e. less than one year)
- •Target lesion meets any of the following criteria:
- •In-stent restenotic
- •aorto-ostial location (within 3 mm)
- •left main location
- •located within 2 mm of the origin of the left anterior descending artery (LAD) or left circumflex artery (LCX)
- •located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft (defined as vessel irregularity per angiogram and > 20% stenosed lesion by visual estimation)
- •lesion involving a side branch ≥ 2.5 mm in diameter
- •lesion involving a side branch with > 50% stenosis by visual estimation Lesion involving a side branch requiring predilatation
- •located in a major epicardial vessel that has been previously treated with brachytherapy
- •located in a major epicardial vessel or a side branch that has been previously treated with any type of percutaneous intervention (e.g., balloon angioplasty, cutting balloon, atherectomy), < 9 months prior to the index procedure
- •total occlusion (TIMI flow 0), prior to wire crossing
- •excessive tortuosity proximal to or within the lesion
- •extreme angulation (≥ 90%) proximal to or within the lesion
- •heavy calcification
- •The target vessel contains visible thrombus
- •Patient has a high probability that a procedure other than pre-dilatation, stenting and post-dilatation will be required at the time of index procedure for treatment of the target vessel (e.g. brachytherapy)
- •Patient has additional clinically significant lesion(s) (> 50% diameter stenosis) in a target vessel or side branch for which an intervention within 9 months after the index procedure may be required
研究组 & 干预措施
TAXUS® Liberté™
干预措施: TAXUS® Liberté™ (Device)
XIENCE V® EECSS
干预措施: XIENCE V® EECSS (Device)
结局指标
主要结局
In-stent Late Loss (LL)
时间窗: 270 days
In-stent minimal lumen diameter (MLD) post-procedure minus (-) in-stent MLD at follow-up
次要结局
- In-segment Angiographic Binary Restenosis Rate(270 days)
- Clinical Device Success (Per-lesion)(immediately post-procedure)
- Clinical Procedure Success (Per-patient)(immediately post-procedure)
- In-segment Late Loss(270 days)
- Proximal Late Loss(270 day)
- Distal Late Loss(270 days)
- In-stent Angiographic Binary Restenosis Rate(270 days)
- In-stent Percent Diameter Stenosis (% DS)(270 days)
- In-segment Percent Diameter Stenosis (% DS)(270 days)
- Adjudicated Stent Thrombosis (Confirmed/Definite, Probable, Possible)(365 days)
- Adjudicated Revascularizations (Target Lesion Revascularization (TLR)/ Target Vessel Revascularization (TVR)/Any Revascularization) Both Clinically-indicated and Not Clinically-indicated.(393 days)
- Adjudicated Composite Endpoint of Cardiac Death, Myocardial Infarction (MI) Attributed to the Target Vessel and Clinical-indicated Target Lesion Revascularization (CI-TLR)(393 days)
- Adjudicated Composite Endpoint of All Death, MI and Target Vessel Revascularization (TVR)(393 days)
- Adjudicated Composite Endpoint of All Death, Any Myocardial Infarction (MI) and Any Revascularization (TLR/TVR/Non-TVR)(37 days)
- Adjudicated Composite Endpoint of All Death, Any Myocardial Infarction (MI) and Any Revascularization (TLR/TVR/Non TVR)(393 days)
- Adjudicated Stent Thrombosis (Confirmed/Definite, Probable, Possible)(0 to 37 days)
- Adjudicated Composite Endpoint of Cardiac Death, Myocardial Infarction (MI) Attributed to the Target Vessel and Clinical-indicated Target Lesion Revascularization (CI-TLR)(254 days)
- Adjudicated Stent Thrombosis (Confirmed/Definite, Probable, Possible)(254 days)
- Adjudicated Revascularizations (Target Lesion Revascularization (TLR)/ Target Vessel Revascularization (TVR)/Any Revascularization) Both Clinically-indicated and Not Clinically-indicated.(37 days)
- Adjudicated Revascularizations (Target Lesion Revascularization (TLR)/ Target Vessel Revascularization (TVR)/Any Revascularization) Both Clinically-indicated and Not Clinically-indicated.(254 days)
- Adjudicated Composite Endpoint of Cardiac Death, Myocardial Infarction (MI) Attributed to the Target Vessel and Clinical-indicated Target Lesion Revascularization (CI-TLR)(37 days)
- Adjudicated Composite Endpoint of All Death, MI and Target Vessel Revascularization (TVR)(37 days)
- Adjudicated Composite Endpoint of All Death, MI and Target Vessel Revascularization (TVR)(254 days)
- Adjudicated Composite Endpoint of All Death, Any Myocardial Infarction (MI) and Any Revascularization (TLR/TVR/Non TVR)(254 days)