NCT00908947终止不适用
CONTINuous Infra-Inguinal Stenting Using the Bard® LifeStent® VascUlar Stent SysteMs ("CONTINUUM")
C. R. Bard58 个研究点 分布在 1 个国家目标入组 173 人开始时间: 2011年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 173
- 试验地点
- 58
- 主要终点
- Primary Effectiveness Endpoint: Primary Target Lesion Patency (TLP) at Time of Procedure and 12-Months Post-Index Procedure
研究概览
简要总结
The objectives of this study are to collect post-market confirmatory evidence of the safety and effectiveness of the Bard® LifeStent® Vascular Stent System and LifeStent® XL Vascular Stent System (together the "LifeStent® Vascular Stent System").
详细描述
The study is a prospective, multi-center, single-arm, non-randomized study enrolling up to 234 subjects with lifestyle-limiting claudication or ischemic rest pain attributable to lesion(s) (stenosed, occluded, restenosed, or re-occluded) in the infra-inguinal segment (Superficial femoral artery [SFA] and/or proximal popliteal artery) that are amenable to treatment by percutaneous transluminal angioplasty (PTA) and stenting. All subjects enrolled in the study will receive PTA and stenting.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject provides written informed consent using an Informed Consent Form (ICF) that is reviewed and approved by the Institutional Review Board (IRB) for the site.
- •Subject agrees to comply with the protocol-mandated follow-up procedures and visits.
- •The subject is ≥ 21 years old.
- •Male or female subjects; female subjects of childbearing potential must have a negative urine pregnancy test at the time of screening.
- •The subject has lifestyle-limiting claudication or ischemic rest pain defined as: Rutherford Category 2-
- •The target lesion(s) has angiographic evidence of stenosis or restenosis ≥ 50% or occlusion (by visual estimate) and is amenable to PTA with stenting.
- •The total target lesion(s) length must be ≤ 240 mm.
- •The target vessel reference diameter is ≥ 4.0 mm and ≤ 6.5 mm (by visual estimate), and therefore appropriate for treatment with available stent diameters of 6.0 mm and 7.0 mm.
排除标准
- •The subject is unable or unwilling to provide informed consent, or is unable or unwilling to conform to the study protocol follow-up procedures and visits.
- •The subject has claudication or critical limb ischemia described as Rutherford Category 1 (mild claudication), 5 (minor tissue loss) or 6 (major tissue loss.
- •The subject has multiple stenoses or occlusions > 240 mm.
- •The subject has a previous stent or stent graft located in the target vessel.
- •The subject has flow-limiting stenosis or occlusion of the inflow tract that cannot be adequately corrected (≤ 30% residual stenosis) prior to treatment of the target lesion(s). Investigator standard of care practices shall be utilized for treatment of inflow.
- •The subject has a known contraindication (including allergic reaction) to antiplatelet/anticoagulant medications, nickel, titanium, tantalum or sensitivity.
- •The subject has a known contraindication to contrast media that is not amenable to pretreatment with steroids or/and antihistamines.
- •The subject has a known history of bleeding diatheses or coagulopathy.
- •The subject has concomitant renal failure with a creatinine of > 2.5 mg/dL.
- •The subject is currently on dialysis or receiving systemic immunosuppressive therapy.
- •The subject has known concomitant hepatic insufficiency, thrombophlebitis, uremia, systemic lupus erythematosus, septicemia or deep vein thrombosis at the time of the index procedure.
- •The subject is currently participating in an investigational drug or another investigational device study that has not completed the primary endpoint, or that clinically interferes with the study endpoints. Note: trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.
- •The subject has another medical condition, which, in the opinion of the Investigator, may cause him/her to be non-compliant with the protocol, confound the data interpretation, or is associated with a life expectancy insufficient to allow for the completion of study procedures and follow-up.
- •The subject has extensive peripheral vascular disease, which in the opinion of the Investigator, would preclude safe insertion of an introducer sheath.
- •The target lesion(s) is located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion(s).
- •There is angiographic evidence of unresolved thrombus at the target lesion(s) or within the target vessel that does not resolve with infusion of thrombolytics and/or mechanical thrombectomy (using an approved device) without adverse events/complications.
- •The subject has undergone any non-iliac percutaneous intervention(s) < 7 days prior to the index procedure.
结局指标
主要结局
Primary Effectiveness Endpoint: Primary Target Lesion Patency (TLP) at Time of Procedure and 12-Months Post-Index Procedure
时间窗: At time of procedure (acute) and 12-months post-index procedure (Chronic)
The primary effectiveness endpoint of the study, device success, collectively measured both acute and chronic effectiveness. Acute effectiveness is defined as successful delivery of the stent to the intended site with the post-deployment stent length being within 10% of the pre-deployment stent length. Chronic effectiveness is defined as Primary Target Lesion Patency (TLP) at 12-months post-index procedure, as measured by Duplex Ultrasound (DUS).
Primary Safety Endpoint: Freedom From Death at 30-days and 12-months Post-Index Procedure.
时间窗: 30-days and 12-months
Primary safety endpoint defined as freedom from occurrence of death at 30-days and 12-months post-index procedure.
次要结局
- Secondary Safety Endpoint: Freedom From Composite Adverse Events(30-days and 12-, 24-, and 36-months post-index procedure)
- Cumulative (Primary Assisted and Secondary) Target Lesion Patency (TLP) at 12, 24, and 36 Months Post-Index Procedure(12, 24, and 36 Months Post-Index Procedure)
- Primary Effectiveness: Device Success at 12-Months Post-Index Procedure for Target Lesion Lengths > 160 mm Compared to LifeStent 200 mm.(12-months Post-Index Procedure)
- Number of Acute Lesion Success(Intra-procedure)
- Primary Safety: Freedom From Death at 30-days and 12-months Post-Index Procedure for Target Lesion Lengths >160 mm Compared With LifeStent 200 mm.(30-days and 12-months Post -Index Procedure)
- Number of Stents Deployed With Acute Technical Success(Intra-procedure)
- Sustained Freedom From Target Lesion Reintervention (TLR) and/or Target Vessel Reintervention (TVR) at 24 and 36 Months Post-Index Procedure(24- and 36-months post-index procedure)
- Number of Participants With Sustained Clinical Success at 30-Days, 12, 24, and 36- Months Post-Index Procedure(30-days and 12-, 24-, and 36-months post-index procedure)
- Sustained Target Lesion Patency (TLP) at 24 and 36 Months Post-Index Procedure(24- and 36-months post-index procedure)
- Expanded Target Lesion Patency (TLP) for Peak Systolic Velocity Ratio (PSR) < 3.0 at 12, 24, and 36 Months Post-Index Procedure(12, 24, and 36 months Post-Index Procedure)
- Change From Baseline in Walking Impairment Questionnaire (WIQ) Results at 30-Days and 12, 24 and 36-Months Post-Index Procedure(30-days, and 12-, 24-, and 36-months post-index procedure)
- Primary Target Lesion Patency (TLP) for Lesions > 160 mm at 12, 24, and 36 Months Post-Index Procedure(12, 24, and 36 months Post Index Procedure)
- Freedom From Target Lesion Revascularization (TLR) and/or Target Vessel Revascularization (TVR) at 12, 24, and 36-Months Post-Index Procedure for Target Lesion Lengths > 160 mm.(12-, 24-, and 36-months post-index procedure)
- Number of Procedures With Acute Success(Intra-procedure)
- Freedom From Target Lesion Revascularization (TLR) and/or Target Vessel Revascularization (TVR) at 12-months Post-index Procedure.(12-months post-index procedure)
- Freedom From Fracture at 12 and 24-Months Post-Index Procedure(12- and 24-months post-index procedure)
- Number of Participants With Sustained Hemodynamic Success at 30-days, 12-, 24-, and 36-Months Post Index Procedure(30 days, 12-, 24-, and 36-months post-index procedure)
研究者
研究点 (58)
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