NCT02060630已完成不适用
Best Endovascular Versus Best Surgical Therapy in Patients With Critical Limb Ischemia
Carelon Research319 个研究点 分布在 1 个国家目标入组 1,843 人开始时间: 2014年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,843
- 试验地点
- 319
- 主要终点
- The primary efficacy endpoint: MALE (Major Adverse Limb Event)-free survival. MALE is defined as above ankle amputation of the index limb or major re-intervention (e.g. new bypass graft, jump/interposition graft revision, or thrombectomy/ thrombolysis)
研究概览
简要总结
This study will compare the effectiveness of best available surgical treatment with best available endovascular treatment in adults with critical limb ischemia (CLI) who are eligible for both treatment options.
详细描述
Male and female subjects aged 18 years or older will be randomized to receive either open surgical treatment or endovascular treatment. They will be followed for at least 2 years and up to 4 years and 2 months after treatment to primarily assess survival and major adverse limb events in the index or treated limb, and secondarily, to determine clinical and cost effectiveness outcomes after treatment. These outcomes (survival-free of major limb events and clinical, functional and cost effectiveness) will be compared within two cohorts of subjects: those with an available single-segment great saphenous vein, and those with an alternative conduit. The null hypotheses for both cohorts is that there will be no difference in MALE-free survival between best endovascular therapy and best surgical therapy.
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
- 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
- •Male or female, age 18 years or older.
- •Infrainguinal PAOD (occlusive disease of the arteries below the inguinal ligament).
- •CLI, defined as arterial insufficiency with gangrene, non-healing ischemic ulcer, or rest pain consistent with Rutherford categories 4-
- •Candidate for both endovascular and open infrainguinal revascularization as judged by the treating investigators
- •Adequate aortoiliac inflow.
- •Adequate popliteal, tibial or pedal revascularization target defined as an infrainguinal arterial segment distal to the area of stenosis/occlusion which can support a distal anastomosis of a surgical bypass.
- •Willingness to comply with protocol, attend follow-up appointments, complete all study assessments, and provide written informed consent.
排除标准
- •Presence of a popliteal aneurysm (>2 cm) in the index limb.
- •Life expectancy of less than 2 years due to reasons other than PAOD.
- •Excessive risk for surgical bypass (as determined by the operating surgeon and the CLI Team)
- •Planned above ankle amputation on ipsilateral limb within 4 weeks of index procedure.
- •Active vasculitis, Buerger's disease, or acute limb-threatening ischemia
- •Any prior index limb infrainguinal stenting or stent grafting associated with significant restenosis within 1 cm of stent or stent-graft, unless the occlusion/restenosis site is outside the intended treatment zone (i.e.,. a tibial vessel that is not currently intended to be revascularized as a part of the treatment for CLI).
- •Any of the following procedures performed on the index limb within 3 months prior to enrollment:
- •Infrainguinal balloon angioplasty, atherectomy, stent, or stentgraft;
- •Infrainguinal bypass with either venous or prosthetic conduit
- •Open surgical inflow procedure (aortofemoral, axillofemoral, iliofemoral, thoracofemoral or femorofemoral bypass) within 6 weeks prior to enrollment
- •Current chemotherapy or radiation therapy.
- •Absolute contraindication to iodinated contrast due to prior near-fatal anaphylactoid reaction (laryngospasm, bronchospasm, cardiorespiratory collapse, or equivalent) which would preclude patient participation in angiographic procedures.
- •Pregnancy or lactation.
- •Administration of an investigational drug for PAD within 30 days of randomization.
- •Participation in a clinical trial (except observational studies) within the previous 30 days.
- •Prior enrollment or randomization into BEST-CLI.
结局指标
主要结局
The primary efficacy endpoint: MALE (Major Adverse Limb Event)-free survival. MALE is defined as above ankle amputation of the index limb or major re-intervention (e.g. new bypass graft, jump/interposition graft revision, or thrombectomy/ thrombolysis)
时间窗: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
* Time to major adverse limb event or death, whichever occurs first in subjects with Single-Segment Great Saphenous Vein (SSGSV) available * Time to major adverse limb event or death, whichever occurs first in subjects without available SSGSV
次要结局
- Clinical: Freedom from hemodynamic failure (cohort 1)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
- Clinical: Freedom from MALE-POD (POD, defined as death within 30 days of index procedure) (cohort 1)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
- Clinical: Re-intervention and amputation-free survival (cohort 2)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
- Clinical: Freedom from POD (POD, defined as death within 30 days of index procedure) (cohort 1)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
- Clinical: Freedom POD (POD, defined as death within 30 days of index procedure) (cohort 2)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
- Clinical: Freedom from Myocardial Infarction (cohort 1)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
- Clinical: Freedom from Stroke (cohort 2)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
- Clinical: Number of re-interventions (major and minor) in per limb salvaged (cohort 2)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
- Clinical: Freedom from clinical failure (cohort 1)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
- Functional: Quality of Life assessment using VasuQoL (cohort 2)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
- Clinical: Re-intervention and amputation-free survival (cohort 1)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
- Clinical: Number of re-interventions (major and minor) in per limb salvaged (cohort 1)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
- Clinical: Freedom from clinical failure (cohort 2)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
- Clinical: Freedom from Critical Limb Ischemia (CLI) (cohort 2)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
- Clinical: Freedom from all-cause mortality (cohort 2)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
- Functional: Numerical rating scale for Pain, Worst level of Pain (cohort 1)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
- Clinical: Clinical: Freedom from MALE-POD (POD, defined as death within 30 days of index procedure) (cohort 2)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
- Clinical: Amputation-free survival (cohort 1)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
- Clinical: Amputation-free survival (cohort 2)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
- Clinical: Freedom from Myocardial Infarction (cohort 2)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
- Clinical: Freedom from Stroke (cohort 1)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
- Functional: Quality of Life assessment using EuroQoL (cohort 1)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
- Functional: Numerical rating scale for Pain, Pain Now (cohort 2)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
- Functional: Numerical rating scale for Pain, Usual level of Pain (cohort 1)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
- Functional: Numerical rating scale for Pain, Worst level of Pain (cohort 2)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
- Clinical: Freedom from re-intervention (major and minor) in index leg (cohort 1)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
- Clinical: Freedom from re-intervention (major and minor) in index leg (cohort 2)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
- Clinical: Freedom from hemodynamic failure (cohort 2)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
- Clinical: Freedom from Critical Limb Ischemia (CLI) (cohort 1)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
- Functional: Quality of Life assessment using VasuQoL (cohort 1)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
- Functional: Quality of Life assessment using EuroQoL (cohort 2)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
- Functional: Function assessment using SF-12, MCS (cohort 1)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
- Functional: Function assessment using SF-12, SF-6D R2 (cohort 1)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
- Functional: Numerical rating scale for Pain, Best level of Pain (cohort 2)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
- Clinical: Freedom from all-cause mortality (cohort 1)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
- Functional: Function assessment using SF-12, PCS (cohort 1)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
- Functional: Function assessment using SF-12, PCS (cohort 2)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
- Functional: Numerical rating scale for Pain, Pain Now (cohort 1)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
- Functional: Function assessment using SF-12, MCS (cohort 2)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
- Functional: Function assessment using SF-12, SF-6D R2(cohort 2)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
- Functional: Numerical rating scale for Pain, Usual level of Pain (cohort 2)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
- Functional: Numerical rating scale for Pain, Best level of Pain (cohort 1)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
- Function: Six-minute walk test (cohort 2)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
- Function: Six-minute walk test (cohort 1)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
研究者
研究点 (319)
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