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临床试验/NCT00856856
NCT00856856已完成不适用

A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System (BVS EECSS) in the Treatment of Patients With de Novo Native Coronary Artery Lesions.

Abbott Medical Devices12 个研究点 分布在 8 个国家目标入组 101 人开始时间: 2009年3月1日最近更新:
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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
101
试验地点
12
主要终点
Hierarchical Major Adverse Cardiac Event (MACE)
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 assess the safety and performance of the BVS Everolimus Eluting Coronary Stent System (EECSS) in the treatment of patients with a maximum of two de novo native coronary artery lesions located in two different major epicardial vessels.

Currently in development at Abbott Vascular. Not available for sale in the United States.

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
18 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •General inclusion criteria
  • •Patient must be at least 18 years of age.
  • •Patient is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the BVS Everolimus Eluting CSS and he/she or his/her legally authorized representative provides written informed consent prior to any Clinical Investigation related procedure, as approved by the appropriate Ethics Committee of the respective clinical site.
  • •Patient 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)
  • •Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery
  • •Patient must agree to undergo all clinical investigation plan-required follow-up visits, angiograms, intravascular ultrasound (IVUS), Palpography (optional), optical coherence tomography (OCT) (strongly recommended), multislice computed tomography (MSCT) (optional) and coronary vasomotion (optional)
  • •Patient must agree not to participate in any other clinical investigation for a period of two years following the index procedure
  • •Angiographic Inclusion Criteria
  • •Target lesion(s) must be located in a native coronary artery with visually estimated nominal vessel diameter of 3.0 mm
  • •Target lesion(s) must measure ≤ 14 mm in length by visual estimation
  • •Target lesion(s) must be in a major artery or branch with a visually estimated stenosis of ≥ 50% and < 100% with a TIMI flow of ≥ 1
  • •If two target lesions meet the inclusion criteria they must be in different major epicardial vessels left anterior descending artery (LAD) with septal and diagonal branches, left circumflex artery (LCX) with obtuse marginal and/or ramus intermedius branches and right coronary artery (RCA) and any of its branches
  • •If two target lesion(s) are being treated, each of these lesions must meet all angiographic inclusion/

排除标准

  • •Non-Clinical Investigation, percutaneous intervention for lesions in a non-target vessel is allowed if done ≥ 90 days prior to or if planned to be done 6 months after the index procedure
  • •Non-Clinical Investigation percutaneous intervention for lesion in the target vessel is allowed if done > 6 months prior to or if planned to be done 6 months after the index procedure
  • •General Exclusion Criteria
  • •Patients has had a known diagnosis of acute myocardial infarction (AMI) within 3 days preceding the index procedure and creatine kinase (CK) and CK-MB have not returned within normal limits at the time of procedure
  • •The patient is currently experiencing clinical symptoms consistent with AMI
  • •Patient has current unstable arrhythmias
  • •Patient has a known left ventricular ejection fraction (LVEF) < 30%
  • •Patient has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant
  • •Patient is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or after the procedure
  • •Patient is receiving immunosuppression therapy and has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.)
  • •Patient is receiving or scheduled to receive chronic anticoagulation therapy (e.g., heparin, coumadin)
  • •Patient has a known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, both clopidogrel and ticlopidine, everolimus, poly (L-lactide), poly (DL-lactide) or contrast sensitivity that cannot be adequately pre-medicated
  • •Elective surgery is planned within the first 6 months after the procedure that will require discontinuing either aspirin or clopidogrel
  • •Patient has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3, a white blood cell count of < 3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis)
  • •Patient has known renal insufficiency (e.g., serum creatinine level of more than 2.5 mg/dL, or patient on dialysis)
  • •Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
  • •Patient has had a cerebrovascular accident (CVA) or transient ischemic neurological attack (TIA) within the past six months
  • •Patient has had a significant GI or urinary bleed within the past six months
  • •Patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion
  • •Patient has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the clinical investigation plan, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year)
  • •Patient is already participating in another clinical investigation that has not yet reached its primary endpoint
  • •Pregnant or nursing patients and those who plan pregnancy during the Clinical Investigation. (Female patients of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure and effective contraception must be used during participation in this Clinical Investigation)
  • •Patient has received brachytherapy in any epicardial vessel (including side branches)
  • •Angiographic Exclusion Criteria
  • •Target lesion(s) meets any of the following criteria:
  • •Aorto-ostial location (within 3 mm)
  • •Left main location
  • •Located within 2 mm of the origin of the LAD or LCX
  • •Located within an arterial or saphenous vein graft or distal to a diseased (defined as vessel irregularity per angiogram and > 20% stenosed lesion, by visual estimation) arterial or saphenous vein graft
  • •Lesion involving a bifurcation ≥ 2 mm in diameter and ostial lesion > 40% stenosed by visual estimation or side branch requiring predilatation
  • •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
  • •Restenotic from previous intervention
  • •The target vessel contains visible thrombus
  • •Another clinically significant lesion is located in the same major epicardial vessel as the target lesion(s) (including side branches)
  • •Patient has a high probability that a procedure other than pre-dilatation and stenting and (if necessary) post-dilatation will be required at the time of index procedure for treatment of the target vessel (e.g. atherectomy, cutting balloon or brachytherapy)

研究组 & 干预措施

Absorb stent

Experimental

Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)

干预措施: Bioabsorbable Everolimus Eluting Coronary Stent (Device)

结局指标

主要结局

Hierarchical Major Adverse Cardiac Event (MACE)

时间窗: 1 year

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).

In-scaffold Late Loss: In-scaffold MLD Post-procedure - In-scaffold MLD at 180 Days

时间窗: 180 days

In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.

In-scaffold Late Loss: In-scaffold MLD Post-procedure - In-scaffold MLD at 1 Year

时间窗: 1 year

In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up

Hierarchical Major Adverse Cardiac Event (MACE)

时间窗: 30 days

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).

次要结局

  • In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 2 Years(2 years)
  • In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 3 Years(3 years)
  • Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 2 Years(2 years)
  • Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 3 Years(3 years)
  • In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 5 Years(5 years)
  • Clinical Device Success (Per Lesion)(On day 0 (the day of procedure))
  • Clinical Procedure Success (Per Patient)(On day 0 (the day of procedure))
  • Hierarchical Target Vessel Failure (TVF)(5 years)
  • Hierarchical Major Adverse Cardiac Event (MACE)(5 years)
  • Cardiac Death(5 years)
  • Myocardial Infarction(5 years)
  • Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 1 Year(1 year)
  • Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 2 Years(2 years)
  • Persisting Dissection(5 years)
  • Volume Obstruction (VO)(3 year)
  • Ischemia Driven Target Lesion Revascularization (ID-TLR)(5 years)
  • Ischemia Driven Target Vessel Revascularization (ID-TVR)(5 years)
  • Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 180 Days(180 days)
  • Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 1 Year(1 year)
  • Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 180 Days(180 days)
  • Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 3 Years(3 years)
  • Aneurysm(5 years)
  • Late Incomplete Apposition(3 year)
  • Scaffold Thrombosis(5 years)
  • Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 5 Years(5 years)
  • In-scaffold Percent Diameter Stenosis (%DS)(5 years)
  • Persisting Incomplete Apposition(3 year)
  • Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 5 Years(5 years)
  • Vasomotion Analysis: In-scaffold Mean Luminal Diameter(5 years)
  • In-scaffold Angiographic Binary Restenosis (ABR)(5 years)
  • Thrombus(5 years)
  • Volume Obstruction (VO)(1 year)
  • In-scaffold Angiographic Binary Restenosis (ABR)(3 years)
  • Persisting Dissection(180 days)
  • Persisting Dissection(1 year)
  • Persisting Dissection(2 years)
  • Persisting Dissection(3 years)
  • Thrombus(3 years)
  • Hierarchical Major Adverse Cardiac Event (MACE)(180 days)
  • Hierarchical Major Adverse Cardiac Event (MACE)(270 days)
  • Hierarchical Major Adverse Cardiac Event (MACE)(2 years)
  • Hierarchical Major Adverse Cardiac Event (MACE)(3 years)
  • Hierarchical Major Adverse Cardiac Event (MACE)(4 years)
  • Hierarchical Target Vessel Failure (TVF)(30 days)
  • Hierarchical Target Vessel Failure (TVF)(180 days)
  • Hierarchical Target Vessel Failure (TVF)(270 days)
  • Hierarchical Target Vessel Failure (TVF)(1 year)
  • Hierarchical Target Vessel Failure (TVF)(2 years)
  • Hierarchical Target Vessel Failure (TVF)(3 years)
  • Hierarchical Target Vessel Failure (TVF)(4 years)
  • Ischemia Driven Target Lesion Revascularization (ID-TLR)(30 days)
  • Ischemia Driven Target Lesion Revascularization (ID-TLR)(180 days)
  • Ischemia Driven Target Lesion Revascularization (ID-TLR)(270 days)
  • Ischemia Driven Target Lesion Revascularization (ID-TLR)(1 year)
  • Ischemia Driven Target Lesion Revascularization (ID-TLR)(2 years)
  • Ischemia Driven Target Lesion Revascularization (ID-TLR)(3 years)
  • Ischemia Driven Target Lesion Revascularization (ID-TLR)(4 years)
  • Ischemia Driven Target Vessel Revascularization (ID-TVR)(30 days)
  • Ischemia Driven Target Vessel Revascularization (ID-TVR)(180 days)
  • Ischemia Driven Target Vessel Revascularization (ID-TVR)(270 days)
  • Ischemia Driven Target Vessel Revascularization (ID-TVR)(1 year)
  • Ischemia Driven Target Vessel Revascularization (ID-TVR)(2 years)
  • Ischemia Driven Target Vessel Revascularization (ID-TVR)(3 years)
  • Ischemia Driven Target Vessel Revascularization (ID-TVR)(4 years)
  • Cardiac Death(30 days)
  • Cardiac Death(1 year)
  • Cardiac Death(2 years)
  • Cardiac Death(3 years)
  • Cardiac Death(4 years)
  • Myocardial Infarction(30 days)
  • Myocardial Infarction(1 year)
  • Myocardial Infarction(2 years)
  • Myocardial Infarction(3 years)
  • Myocardial Infarction(4 years)
  • Scaffold Thrombosis(30 days)
  • Scaffold Thrombosis(1 year)
  • Scaffold Thrombosis(2 years)
  • Scaffold Thrombosis(3 years)
  • Scaffold Thrombosis(4 years)
  • In-scaffold Angiographic Binary Restenosis (ABR)(180 days)
  • In-scaffold Angiographic Binary Restenosis (ABR)(1 year)
  • In-scaffold Angiographic Binary Restenosis (ABR)(2 years)
  • In-scaffold Percent Diameter Stenosis (%DS)(180 days)
  • In-scaffold Percent Diameter Stenosis (%DS)(1 year)
  • In-scaffold Percent Diameter Stenosis (%DS)(2 years)
  • In-scaffold Percent Diameter Stenosis (%DS)(3 years)
  • Aneurysm(180 days)
  • Aneurysm(1 year)
  • Aneurysm(2 years)
  • Aneurysm(3 years)
  • Thrombus(180 days)
  • Thrombus(1 year)
  • Thrombus(2 years)
  • Volume Obstruction (VO)(180 days)
  • Volume Obstruction (VO)(2 year)
  • Persisting Incomplete Apposition(180 days)
  • Persisting Incomplete Apposition(1 year)
  • Persisting Incomplete Apposition(2 year)
  • Late Incomplete Apposition(180 days)
  • Late Incomplete Apposition(1 year)
  • Late Incomplete Apposition(2 year)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (12)

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