A Study of the Gore VIABAHN BX for Treatment of Occlusive Disease in the Iliac Arteries. (VBXFLEX)
2018年12月27日 更新者：W.L.Gore & Associates
Evaluation of the Gore(R) Viabahn(R) Balloon Expandable Endoprosthesis (VIABAHN BX) for the Treatment of Occlusive Disease in the Common and External Iliac Arteries.
Evaluation of the Gore(R) VIABAHN BX for the treatment of arterial occlusive disease in the common and/or external iliac arteries.
研究概览
详细说明
This study is a prospective, multicenter, non-randomized single-arm clinical study to evaluate the safety and efficacy of the VIABAHN BX for the treatment of arterial occlusive disease in patients with de novo or restenotic lesions in the common and/or external iliac arteries.
研究类型
介入性
注册 (实际的)
134
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Auckland、新西兰
- Auckland City Hospital
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Arizona
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Phoenix、Arizona、美国、85006
- St. Luke's Medical Center
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Connecticut
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New Haven、Connecticut、美国、06518
- Yale University School Of Medicine
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District of Columbia
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Washington、District of Columbia、美国、20782
- Medstar Health Research Institute
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Florida
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Miami、Florida、美国、33136
- University of Miami
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Miami、Florida、美国、33176
- Baptist Cardiac and Vascular Institute
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Pensacola、Florida、美国、32504
- Coastal Vascular Institute
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Illinois
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Elk Grove Village、Illinois、美国、60007
- Cardiovascular Associates
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Iowa
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West Des Moines、Iowa、美国、50266
- Iowa Methodist Medical Center
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Kentucky
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Louisville、Kentucky、美国、40202
- University of Louisville
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Minnesota
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Duluth、Minnesota、美国、55805
- Essentia Institute for Rural Health / St Mary's Hospital
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Plymouth、Minnesota、美国、55422
- North Memorial Heart & Vascular Institute
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New Jersey
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Morristown、New Jersey、美国、07960
- Advanced Vascular Associates
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Teaneck、New Jersey、美国、07666
- Holy Name Medical Center
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New York
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Buffalo、New York、美国、14203
- Research Foundation SUNY Buffalo
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New York、New York、美国、10065
- Cornell University
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North Dakota
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Fargo、North Dakota、美国、58122
- Sanford Clinic - Clinical Research
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Ohio
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Columbus、Ohio、美国、43214
- Ohio Health
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Pennsylvania
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Camp Hill、Pennsylvania、美国、17011
- Holy Spirit Cardiovascular Institute
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Pittsburgh、Pennsylvania、美国、15213
- UPMC
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Rhode Island
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Providence、Rhode Island、美国、02906
- The Miriam Hospital
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South Carolina
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Charleston、South Carolina、美国、29425
- MUSC
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Greenville、South Carolina、美国、29615
- Greenville Memorial Hospital
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Tennessee
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Chattanooga、Tennessee、美国、37403
- University Surgical Associates
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Kingsport、Tennessee、美国、37660
- Wellmont Holston Valley Medical Center
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Texas
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Houston、Texas、美国、77030
- The Methodist Hospital
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Virginia
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Norfolk、Virginia、美国、23507
- Sentara Medical Group
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Patient is at least 18 years old;
- Patient is male, infertile female, or female of childbearing potential practicing an acceptable method of preventing pregnancy;
- Patient or legal representative is willing to give written informed consent;
- Patient is capable of complying with protocol requirements, including all follow-up visits;
- Patient has symptomatic claudication or rest pain without tissue loss (Rutherford Categories 2-4).
- Patient has de novo or restenotic target lesion(s) in the common and/or external iliac artery;
- Patient has one or more regions of stenosis ≥ 50% in the target vessel, based on visual estimate;
- Patient has a target vessel diameter visually estimated to be approximately between 5 mm and 13 mm;
- Patient has adequate ipsilateral blood flow including at least one sufficient (<50% stenotic) infrapopliteal run-off vessel not requiring intervention (per side to be intervened on).
- Patient has a total target lesion length visually estimated to be ≤110 mm which can be treated with a maximum of three VIABAHN BX endoprostheses;
- Patient has no more than two discrete ipsilateral lesions that can be treated with no more than three VIABAHN BX endoprostheses [OR] Patient has bilateral disease consisting of only one target lesion per side that can be treated with no more than a total of three VIABAHN BX endoprostheses;
- Patient has the device advanced across the target lesion(s) and positioned for deployment.
Exclusion Criteria:
- Patient has a life expectancy of less than 1 year;
- Patient has a known allergy to stent graft components, including stainless steel or heparin;
- Patient has a known intolerance to antiplatelet, anticoagulant, or thrombolytic medications that would prevent compliance with the protocol;
- Patient has a condition (unrelated to the study) that is expected to require indefinite, or lifelong, anticoagulation
- Patient has an uncorrected bleeding disorder (platelet count < 80,000/µL);
- Patient has severe chronic renal insufficiency (serum creatinine level > 2.5mg/dL) and not on hemodialysis;
- Patient has a known hypercoagulability that cannot be corrected;
- Patient has evidence of a blood borne infection;
- Patient has had vascular access/catheterization in the lower extremity within 30 days of study enrollment;
- Patient has had a previous or planned coronary intervention within 30 days prior to enrollment in this study or required at time of study procedure;
- Patient has had a previous or planned bypass surgery in the target leg, or a bypass that occurs at the time of the index procedure;
- Patient is currently participating in this or another investigative clinical study.
- Patient has a stent or stent graft located within or immediately adjacent (≤5mm) to study lesion(s);
- Patient has evidence of angiographically visible thrombus within or adjacent to the target lesion(s);
- Patient has aneurysmal dilation proximal or distal to the target lesion(s) that would interfere with the placement of the device;
- Patient has a target lesion requiring atherectomy or any ablative device to facilitate stent delivery;
- Patient has a target lesion situated in such a way that an implanted device will prevent blood flow or perfusion to the internal iliac artery if patent.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：戈尔 VIABAHN BX
髂骨闭塞性疾病的球囊扩张支架术
|
Balloon expandable stenting of iliac occlusive disease.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Composite of Major Adverse Events (MAEs)
大体时间：9 months
|
Percentage of study subjects experiencing a major adverse event (MAE) defined as: device or procedure-related death within 30 days, myocardial infarction (MI) within 30 days, target lesion revascularization (TLR) within 9 months or major amputation of the target limb within 9 months.
|
9 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Acute Procedural Success
大体时间：Discharge
|
Number of subjects who experienced Acute Procedural Success defined as less than or equal to 30% residual stenosis prior to procedure completion and no device- or procedure-related SAEs before discharge.
|
Discharge
|
|
30-Day Clinical Success
大体时间：30 Days
|
Number of subjects who experienced 30-Day Clinical Success defined as an improvement of at least one Rutherford Category at the 30-day visit as compared to pre-procedure and no device- or procedure-related SAEs within 30 days of the index procedure.
|
30 Days
|
|
Percentage of Participants With Primary Patency
大体时间：30 Days
|
Kaplan-Meier estimate of primary patency at 30 days.
|
30 Days
|
|
Percentage of Participants With Primary Patency
大体时间：9 Months
|
Kaplan-Meier estimate of primary patency at 9 months.
|
9 Months
|
|
Percentage of Participants With Primary Assisted Patency
大体时间：30 Days
|
Kaplan-Meier estimate of primary assisted patency at 30 days.
|
30 Days
|
|
Percentage of Participants With Primary Assisted Patency
大体时间：9 Months
|
Kaplan-Meier estimate of primary assisted patency at 9 months.
|
9 Months
|
|
Percentage of Participants With Secondary Patency
大体时间：30 Days
|
Kaplan-Meier estimate of secondary patency at 30 days.
|
30 Days
|
|
Percentage of Participants With Secondary Patency
大体时间：9 Months
|
Kaplan-Meier estimate of secondary patency at 9 months.
|
9 Months
|
|
Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)
大体时间：30 Days
|
Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 30 days.
|
30 Days
|
|
Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)
大体时间：9 Months
|
Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 9 months.
|
9 Months
|
|
Percentage of Participants With Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR)
大体时间：30 Days
|
Kaplan-Meier estimate of freedom from clinically-driven target lesion revascularization (CD-TLR) at 30 days.
|
30 Days
|
|
Percentage of Participants With Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR)
大体时间：9 Months
|
Kaplan-Meier estimate of freedom from clinically-driven target lesion revascularization (CD-TLR) at 9 months.
|
9 Months
|
|
Percentage of Participants With Freedom From Target Vessel Revascularization (TVR)
大体时间：30 Days
|
Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 30 days.
|
30 Days
|
|
Percentage of Participants With Freedom From Target Vessel Revascularization (TVR)
大体时间：9 Months
|
Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 9 months.
|
9 Months
|
|
Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR)
大体时间：30 Days
|
Kaplan-Meier estimate of freedom from clinically-driven target vessel revascularization (CD-TVR) at 30 days.
|
30 Days
|
|
Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR)
大体时间：9 Months
|
Kaplan-Meier estimate of freedom from clinically-driven target vessel revascularization (CD-TVR) at 9 months
|
9 Months
|
|
Number of Participants With Change in Rutherford Category
大体时间：30 Days
|
Number of participants with change in Rutherford Category from pre-procedure at 30 days. Rutherford Categories: Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters. Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene |
30 Days
|
|
Number of Participants With Change in Rutherford Category
大体时间：9 Months
|
Number of participants with change in Rutherford Category from pre-procedure at 9 months. Rutherford Categories: Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters. Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene |
9 Months
|
|
Change in Ankle Brachial Index (ABI)
大体时间：30 Days
|
Ankle brachial Index (ABI) is a common assessment of peripheral artery disease (PAD) and is obtained by comparing the systolic blood pressure of the legs to the systolic blood pressure of the arms.
A normal resting ABI is .9 to 1.3.
A resting ABI of less than .9 is abnormal.
An outcome of a mean ABI above .9
and below 1.3 is considered a success.
|
30 Days
|
|
Change in Ankle Brachial Index (ABI)
大体时间：9 Months
|
Ankle brachial Index (ABI) is a common assessment of peripheral artery disease (PAD) and is obtained by comparing the systolic blood pressure of the legs to the systolic blood pressure of the arms.
A normal resting ABI is .9 to 1.3.
A resting ABI of less than .9 is abnormal.
An outcome of a mean ABI above .9
and below 1.3 is considered a success.
|
9 Months
|
|
Number of Participants With Change in Functional Status - EQ5D - Mobility
大体时间：30 Days
|
Patient reported outcome based on study questionnaire.
Number of participants with change in functional status (EQ5D - Mobility) from pre-procedure at 30 days.
|
30 Days
|
|
Number of Participants With Change in Functional Status - EQ5D - Mobility
大体时间：9 Months
|
Patient reported outcome based on study questionnaire.
Number of participants with change in Functional Status (EQ5D - Mobility) from pre-procedure at 9 months.
|
9 Months
|
|
Number of Participants With Change in Functional Status - EQ5D - Self Care
大体时间：30 Days
|
Patient reported outcome based on study questionnaire.
Number of participants with change in functional status (EQ5D - Self Care) from pre-procedure at 30 days.
|
30 Days
|
|
Number of Participants With Change in Functional Status - EQ5D - Self Care
大体时间：9 Months
|
Patient reported outcome based on study questionnaire.
Number of participants with change in Functional Status (EQ5D - Self Care) from pre-procedure at 9 months.
|
9 Months
|
|
Number of Participants With Change in Functional Status - EQ5D - Usual Activities
大体时间：30 Days
|
Patient reported outcome based on study questionnaire.
Number of participants with change in functional status (EQ5D - Usual Activities) from pre-procedure at 30 days.
|
30 Days
|
|
Number of Participants With Change in Functional Status - EQ5D - Usual Activities
大体时间：9 Months
|
Patient reported outcome based on study questionnaire.
Number of participants with change in functional status (EQ5D - Usual Activities) from pre-procedure at 9 months.
|
9 Months
|
|
Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort
大体时间：30 Days
|
Patient reported outcome based on study questionnaire.
Number of participants with change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 30 days.
|
30 Days
|
|
Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort
大体时间：9 Months
|
Patient reported outcome based on study questionnaire.
Number of participants with change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 9 months.
|
9 Months
|
|
Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression
大体时间：30 Days
|
Patient reported outcome based on study questionnaire.
Number of participants with change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 30 days.
|
30 Days
|
|
Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression
大体时间：9 Months
|
Patient reported outcome based on study questionnaire.
Number of participants with change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 9 months.
|
9 Months
|
|
Number of Participants With Change in Functional Status - EQ5D - Own Health State
大体时间：30 Days
|
Patient reported outcome based on study questionnaire.
Number of participants with change in functional status (EQ5D - Own Health State) from pre-procedure at 30 days.
|
30 Days
|
|
Number of Participants With Change in Functional Status - EQ5D - Own Health State
大体时间：9 Months
|
Patient reported outcome based on study questionnaire.
Number of participants with change in functional status (EQ5D - Own Health State) from pre-procedure at 9 months.
|
9 Months
|
|
Number of Participants With Improvement in Functional Status at 30 Days - Walking Improvement Questionnaire (WIQ)
大体时间：30 Days
|
Patient reported outcome based on study questionnaire.
Percentage of subjects with improvement on WIQ from pre-procedure at 30 days.
|
30 Days
|
|
Number of Participants With Improvement in Functional Status 9 Months - Walking Improvement Questionnaire (WIQ)
大体时间：9 Months
|
Patient reported outcome based on study questionnaire.
Percentage of subjects with improvement on WIQ from pre-procedure at 9 months.
|
9 Months
|
|
Percentage of Participants With Primary Patency
大体时间：12 Months
|
Kaplan-Meier estimate of primary patency at 12 months.
|
12 Months
|
|
Percentage of Participants With Primary Assisted Patency
大体时间：12 Months
|
Kaplan-Meier estimate of primary assisted patency at 12 months.
|
12 Months
|
|
Percentage of Participants With Secondary Patency
大体时间：12 Months
|
Kaplan-Meier estimate of secondary patency at 12 months.
|
12 Months
|
|
Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)
大体时间：12 Months
|
Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 12 months.
|
12 Months
|
|
Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)
大体时间：24 Months
|
Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 24 months.
|
24 Months
|
|
Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)
大体时间：36 Months
|
Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 36 months.
|
36 Months
|
|
Percentage of Participants With Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR)
大体时间：12 Months
|
Kaplan-Meier estimate of freedom from clinically-driven target lesion revascularization (CD-TLR) at 12 months.
|
12 Months
|
|
Percentage of Participants With Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR)
大体时间：24 Months
|
Kaplan-Meier estimate of freedom from clinically-driven target lesion revascularization (CD-TLR) at 24 months.
|
24 Months
|
|
Percentage of Participants With Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR)
大体时间：36 Months
|
Kaplan-Meier estimate of freedom from clinically-driven target lesion revascularization (CD-TLR) at 36 months.
|
36 Months
|
|
Percentage of Participants With Freedom From Target Vessel Revascularization (TVR)
大体时间：12 Months
|
Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 12 months.
|
12 Months
|
|
Percentage of Participants With Freedom From Target Vessel Revascularization (TVR)
大体时间：24 Months
|
Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 24 months.
|
24 Months
|
|
Percentage of Participants With Freedom From Target Vessel Revascularization (TVR)
大体时间：36 Months
|
Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 36 months.
|
36 Months
|
|
Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR)
大体时间：12 Months
|
Kaplan-Meier estimate of freedom from clinically-driven target vessel revascularization (CD-TVR) at 12 months
|
12 Months
|
|
Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR)
大体时间：24 Months
|
Kaplan-Meier estimate of freedom from clinically-driven target vessel revascularization (CD-TVR) at 24 months
|
24 Months
|
|
Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR)
大体时间：36 Months
|
Kaplan-Meier estimate of freedom from clinically-driven target vessel revascularization (CD-TVR) at 36 months
|
36 Months
|
|
Number of Participants With Change in Rutherford Category
大体时间：12 Months
|
Number of participants with change in Rutherford Category from pre-procedure at 12 months. Rutherford Categories: Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters. Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene |
12 Months
|
|
Number of Participants With Change in Rutherford Category
大体时间：24 Months
|
Number of participants with change in Rutherford Category from pre-procedure at 24 months. Rutherford Categories: Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters. Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene |
24 Months
|
|
Number of Participants With Change in Rutherford Category
大体时间：36 Months
|
Number of participants with change in Rutherford Category from pre-procedure at 36 months. Rutherford Categories: Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters. Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene |
36 Months
|
|
Change in Ankle Brachial Index (ABI)
大体时间：12 Months
|
Ankle brachial Index (ABI) is a common assessment of peripheral artery disease (PAD) and is obtained by comparing the systolic blood pressure of the legs to the systolic blood pressure of the arms.
A normal resting ABI is .9 to 1.3.
A resting ABI of less than .9 is abnormal.
An outcome of a mean ABI above .9
and below 1.3 is considered a success.
|
12 Months
|
|
Change in Ankle Brachial Index (ABI)
大体时间：24 Months
|
Ankle brachial Index (ABI) is a common assessment of peripheral artery disease (PAD) and is obtained by comparing the systolic blood pressure of the legs to the systolic blood pressure of the arms.
A normal resting ABI is .9 to 1.3.
A resting ABI of less than .9 is abnormal.
An outcome of a mean ABI above .9
and below 1.3 is considered a success.
|
24 Months
|
|
Change in Ankle Brachial Index (ABI)
大体时间：36 Months
|
Ankle brachial Index (ABI) is a common assessment of peripheral artery disease (PAD) and is obtained by comparing the systolic blood pressure of the legs to the systolic blood pressure of the arms.
A normal resting ABI is .9 to 1.3.
A resting ABI of less than .9 is abnormal.
An outcome of a mean ABI above .9
and below 1.3 is considered a success.
|
36 Months
|
|
Number of Participants With Change in Functional Status - EQ5D - Mobility
大体时间：12 Months
|
Patient reported outcome based on study questionnaire.
Number of participants with change in Functional Status (EQ5D - Mobility) from pre-procedure at 12 months.
|
12 Months
|
|
Number of Participants With Change in Functional Status - EQ5D - Mobility
大体时间：24 Months
|
Patient reported outcome based on study questionnaire.
Number of participants with change in Functional Status (EQ5D - Mobility) from pre-procedure at 24 months.
|
24 Months
|
|
Number of Participants With Change in Functional Status - EQ5D - Mobility
大体时间：36 Months
|
Patient reported outcome based on study questionnaire.
Number of participants with change in Functional Status (EQ5D - Mobility) from pre-procedure at 36 months.
|
36 Months
|
|
Number of Participants With Change in Functional Status - EQ5D - Self Care
大体时间：12 Months
|
Patient reported outcome based on study questionnaire.
Number of participants with change in Functional Status (EQ5D - Self Care) from pre-procedure at 12 months.
|
12 Months
|
|
Number of Participants With Change in Functional Status - EQ5D - Self Care
大体时间：24 Months
|
Patient reported outcome based on study questionnaire.
Number of participants with change in Functional Status (EQ5D - Self Care) from pre-procedure at 24 months.
|
24 Months
|
|
Number of Participants With Change in Functional Status - EQ5D - Self Care
大体时间：36 Months
|
Patient reported outcome based on study questionnaire.
Number of participants with change in Functional Status (EQ5D - Self Care) from pre-procedure at 36 months.
|
36 Months
|
|
Number of Participants With Change in Functional Status - EQ5D - Usual Activities
大体时间：12 Months
|
Patient reported outcome based on study questionnaire.
Number of participants with change in functional status (EQ5D - Usual Activities) from pre-procedure at 12 months.
|
12 Months
|
|
Number of Participants With Change in Functional Status - EQ5D - Usual Activities
大体时间：24 Months
|
Patient reported outcome based on study questionnaire.
Number of participants with change in functional status (EQ5D - Usual Activities) from pre-procedure at 24 months.
|
24 Months
|
|
Number of Participants With Change in Functional Status - EQ5D - Usual Activities
大体时间：36 Months
|
Patient reported outcome based on study questionnaire.
Number of participants with change in functional status (EQ5D - Usual Activities) from pre-procedure at 36 months.
|
36 Months
|
|
Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort
大体时间：12 Months
|
Patient reported outcome based on study questionnaire.
Number of participants with change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 12 months.
|
12 Months
|
|
Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort
大体时间：24 Months
|
Patient reported outcome based on study questionnaire.
Number of participants with change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 24 months.
|
24 Months
|
|
Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort
大体时间：36 Months
|
Patient reported outcome based on study questionnaire.
Number of participants with change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 36 months.
|
36 Months
|
|
Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression
大体时间：12 Months
|
Patient reported outcome based on study questionnaire.
Number of participants with change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 12 months.
|
12 Months
|
|
Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression
大体时间：24 Months
|
Patient reported outcome based on study questionnaire.
Number of participants with change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 24 months.
|
24 Months
|
|
Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression
大体时间：36 Months
|
Patient reported outcome based on study questionnaire.
Number of participants with change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 36 months.
|
36 Months
|
|
Number of Participants With Change in Functional Status - EQ5D - Own Health State
大体时间：12 Months
|
Patient reported outcome based on study questionnaire.
Number of participants with change in functional status (EQ5D - Own Health State) from pre-procedure at 12 months.
|
12 Months
|
|
Number of Participants With Change in Functional Status - EQ5D - Own Health State
大体时间：24 Months
|
Patient reported outcome based on study questionnaire.
Number of participants with change in functional status (EQ5D - Own Health State) from pre-procedure at 24 months.
|
24 Months
|
|
Number of Participants With Change in Functional Status - EQ5D - Own Health State
大体时间：36 Months
|
Patient reported outcome based on study questionnaire.
Number of participants with change in functional status (EQ5D - Own Health State) from pre-procedure at 36 months.
|
36 Months
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Device or Procedure-related Death
大体时间：30 Days
|
Number of subjects experiencing a device or procedure-related death within 30 Days - Component of primary outcome
|
30 Days
|
|
Myocardial Infarction (MI)
大体时间：30 Days
|
Number of subjects experiencing a myocardial infarction (MI) within 30 Days - Component of primary outcome
|
30 Days
|
|
Target Lesion Revascularization (TLR)
大体时间：9 Months
|
Number of subjects experiencing a target lesion revascularization (TLR) within 9 months - Component of primary outcome
|
9 Months
|
|
Major Amputation
大体时间：9 Months
|
Number of subjects experiencing a major amputation of the target limb within 9 months - Component of primary outcome
|
9 Months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Jean Bismuth, MD、The Methodist Hospital Research Institute
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Panneton JM, Bismuth J, Gray BH, Holden A. Three-Year Follow-up of Patients With Iliac Occlusive Disease Treated With the Viabahn Balloon- Expandable Endoprosthesis. J Endovasc Ther. 2020 Oct;27(5):728-736. doi: 10.1177/1526602820920569. Epub 2020 Apr 24.
- Bismuth J, Gray BH, Holden A, Metzger C, Panneton J; VBX FLEX Study Investigators. Pivotal Study of a Next-Generation Balloon-Expandable Stent-Graft for Treatment of Iliac Occlusive Disease. J Endovasc Ther. 2017 Oct;24(5):629-637. doi: 10.1177/1526602817720463. Epub 2017 Jul 12.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2014年7月1日
初级完成 (实际的)
2016年5月1日
研究完成 (实际的)
2018年10月1日
研究注册日期
首次提交
2014年3月4日
首先提交符合 QC 标准的
2014年3月5日
首次发布 (估计)
2014年3月6日
研究记录更新
最后更新发布 (实际的)
2019年1月16日
上次提交的符合 QC 标准的更新
2018年12月27日
最后验证
2018年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.