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临床试验/NCT01115933
NCT01115933已完成不适用

SPIRIT PRIME JAPAN (SV JAPAN)

Abbott Medical Devices15 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2010年4月最近更新:
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适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
65
试验地点
15
主要终点
Composite Endpoint of Cardiac Death/TV-MI/CI-TLR (TLF)
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to evaluate the safety and effectiveness of the AVJ-09-385 Small Vessel Everolimus Eluting Coronary Stent System (EECSS) (2.25 mm diameter stent) in treatment of subjects with ischemic heart disease caused by de novo lesions.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Subject must be at least 20 years of age.
  • •Subject or a legally authorized representative must provide written informed consent prior to any study related procedure, per site requirements.
  • •Subject must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram (ECG) consistent with ischemia).
  • •Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
  • •Subject must agree to undergo all protocol-required follow-up procedures.
  • •Subject must agree not to participate in any other clinical study for a period of one year following the index procedure.
  • •Angiographic Inclusion Criteria
  • •One (target) or two (one target and one non-target) de novo lesions each in a different epicardial vessel.
  • •Lesion(s) must be located in a major artery or branch with a visually estimated diameter stenosis of ≥ 50% and < 100% with a TIMI flow of ≥
  • •Lesion(s) must be located in a native coronary artery with reference vessel diameter (RVD) by visual estimation of ≥ 2.25 mm and < 2.5 mm.
  • •Lesion(s) must be located in a native coronary artery with length by visual estimation of ≤ 22 mm.

排除标准

  • •Subject has had a known diagnosis of acute myocardial infarction (AMI) preceding the index procedure (CK-MB ≥ 2 times upper limit of normal) and CK and CK-MB have not returned to within normal limits at the time of procedure.
  • •The subject is currently experiencing clinical symptoms consistent with new onset AMI, such as nitrate-unresponsive prolonged chest pain with ischemic ECG changes.
  • •Subject has current unstable cardiac arrhythmias associated with hemodynamic instability.
  • •Subject has a known left ventricular ejection fraction (LVEF) < 40% (LVEF may be obtained at the time of the index procedure if the value is unknown and if necessary).
  • •Subject has received coronary brachytherapy in any epicardial vessel.
  • •Subject has received any organ transplant or is on a waiting list for any organ transplant.
  • •Subject is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or within one year after the index procedure.
  • •Subject is receiving or scheduled to receive planned radiotherapy to the chest/mediastinum.
  • •Subject is receiving immunosuppressant therapy or has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.).
  • •Subject is receiving chronic anticoagulation therapy (e.g., heparin, warfarin).
  • •Subject will require Low Molecular Weight Heparin (LMWH) post-procedure.
  • •Subject has a known hypersensitivity or contraindication to aspirin, heparin, clopidogrel/ticlopidine, everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.
  • •Elective surgery is planned within 6 months after the procedure that will require discontinuing either aspirin or clopidogrel.
  • •Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3, a white blood cell (WBC) of < 3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis).
  • •Subject has known renal insufficiency (examples being but not limited to serum creatinine level ≥ 2.0 mg/dL, or on dialysis).
  • •Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
  • •Subject has had a cerebrovascular accident/stroke or transient ischemic neurological attack (TIA) within the past six months.
  • •Subject has had a significant gastro-intestinal or significant urinary bleed within the past six months.
  • •Subject has extensive peripheral vascular disease that precludes safe 5 French catheter insertion.
  • •Subject has other medical illness (e.g., cancer) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year).
  • •Subject is currently participating in another clinical study that has not yet completed its primary endpoint.
  • •Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test*.
  • •Whether a subject who met this criterion will be asked for pregnancy test will be decided per site standard. However, subject enrollment in the study is not allowed without pregnancy test result.
  • •Angiographic Exclusion Criteria All angiographic exclusion criteria are based on visual estimation.
  • •Target lesion located within an arterial or saphenous vein graft or distal to a diseased (vessel irregularity per angiogram and > 20% stenosed lesion) arterial or saphenous vein graft.
  • •Target lesion involving a bifurcation with a side branch ≥ 2 mm in diameter and/or ostial lesion > 40% stenosed or side branch requiring protection guidewire, or side branch requiring dilatation.
  • •Target lesion with total occlusion (TIMI flow 0), prior to crossing with the wire.
  • •Another lesion requiring revascularization is located in the same epicardial vessel of the target lesion.
  • •Restenotic lesion.
  • •Aorto-ostial target lesion (within 3 mm of the aorta junction).
  • •Lesion in the left main trunk (both target and non-target).
  • •Lesion located within 2 mm of the origin of the LAD or LCX.
  • •Extreme angulation (≥ 90 °) or excessive tortuosity (≥ two 45° angles) proximal to or within the target lesion.
  • •Heavy calcification proximal to or within the target lesion.
  • •Target vessel contains thrombus as indicated in the angiographic images.
  • •Target lesion has a high probability that a procedure other than pre-dilatation and stenting will be required at the time of index procedure for treatment of the target vessel (e.g. rotablator, DCA, cutting balloon).
  • •Target vessel is previously treated* with any type of PCI (e.g. balloon angioplasty, stent, rotablator, DCA, cutting balloon) within 9 months of index procedure.
  • •Non-target vessel was previously treated with any type of PCI within 90 days of index procedure.
  • •Additional clinically significant lesion(s) in the target vessel or side branch for which PCI may be required within 90 days after the index procedure.
  • •Target lesion must be separated ≥ 5 mm from a previously treated lesion (stenosis within 5 mm of previously treated lesion is regarded as "restenosis").

研究组 & 干预措施

XIENCE PRIME SV EECSS

Experimental

XIENCE PRIME SV EECSS: Small Vessel Everolimus Eluting Coronary Stent System

干预措施: XIENCE PRIME SV EECSS (Device)

结局指标

主要结局

Composite Endpoint of Cardiac Death/TV-MI/CI-TLR (TLF)

时间窗: 9 Months

Target lesion failure (TLF) is the composite of any of the following adverse events: Cardiac death, target vessel myocardial infarction (TV-MI) (per Protocol definition), Clinically indicated target lesion revascularization (CI-TLR)

次要结局

  • Death (Cardiac, Vascular, Non-Cardiovascular, Per ARC Definition)(9 months)
  • Percent Diameter Stenosis (%DS), In-segment, In-stent, Proximal and Distal(8 months)
  • Target Vessel Revascularization (TVR, Per ARC Definition) Not Clinically-indicated TVR (NCI-TVR)(9 months)
  • Composite Endpoint of Cardiac Death/All MI(9 months)
  • Acute Stent Thrombosis(<24 hours)
  • Device Success (Lesion Based Analysis, Only for XIENCE PRIME SV)(The period during an in-hospital stay of less than or equal to 7 days post index procedure.)
  • Angiographic Binary Restenosis (ABR), In-segment, In-stent, Proximal and Distal(8 months)
  • Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) Attributable to Target Vessel (TV-MI)(9 months)
  • Target Lesion Revascularization (TLR, Per ARC Definition)(9 months)
  • Procedural Success(Subject Base Analysis)(The period during an in-hospital stay of less than or equal to 7 days post index procedure.)
  • Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) Not Attributable to Target Vessel (NTV-MI)(9 months)
  • Target Lesion Revascularization (TLR, Per ARC Definition) Not Clinically-indicated TLR (NCI-TLR)(9 months)
  • Composite Endpoint of Cardiac Death, All MI and CI-TLR (MACE)(9 months)
  • Late Loss (LL), In-segment, In-stent, Proximal and Distal(8 months)
  • Target Lesion Revascularization (TLR, Per ARC Definition) Clinically-indicated TLR (CI-TLR)(9 months)
  • Target Vessel Revascularization (TVR, Per ARC Definition) Clinically-indicated TVR (CI-TVR)(9 months)
  • Acute/Subacute Stent Thrombosis(0-30 days)
  • Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions)(9 months)
  • Target Vessel Revascularization (TVR, Per ARC Definition)(9 months)
  • Composite Endpoint of All Death/All MI/All Revascularization (DMR)(9 months)
  • Composite Endpoint of Cardiac Death/TV-MI/CI-TLR (TLF)(1 month)
  • Composite Endpoint of Cardiac Death/All MI/CI-TLR (MACE)(1 month)
  • All Coronary Revascularization(9 months)
  • Subacute Stent Thrombosis(1-30 days)
  • Overall Stent Thrombosis(0 - 298 days)
  • Late Stent Thrombosis(31 - 298 days)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (15)

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