NCT00518284终止2 期
A Phase II Trial of ABI-007 (Paclitaxel Albumin-bound Particles) for the Prevention of Restenosis Following Revascularization of the Superficial Femoral Artery (SFA)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 7
- 主要终点
- Target Vessel Revascularization at 9 Months
研究概览
简要总结
The purpose of this study is to investigate the prevention of Restenosis following Revascularization of the superficial Femoral Artery (SFA)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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 non-pregnant and non-lactating female and greater than or equal to 18 years of age. All females if child bearing potential must have a negative serum pregnancy test
- •Patient is determined to have peripheral artery disease (PAD) classified as Rutherford category 1-4 (grade I/II) - mild, moderate, or severe claudication or ischemic rest pain
- •Patient has de novo lesion causing occlusion or an angiographic stenosis of at least 50% in the superficial femoral artery
- •Patient has a single or multiple lesions located in the superficial femoral artery with a total length 5-15 cm.
- •Normal vessel diameter of the SFA is 4-6 mm
- •Patient must have a visibly patent (by angiography) popliteal artery below the target lesion
- •No residual flow limiting dissection or residual stenosis greater 30% (visual estimate) after percutaneous balloon angioplasty (PTA) or provisional stenting. Treatment with provisional stenting will be allowed only for flow-limiting dissection, grade C/D or greater than 30 % residual stenosis angiographically after angioplasty alone.
- •No target vessel thrombosis confirmed angiography post-PTA procedure
- •No distal embolization within target limb
- •Patient or his/her legally authorized representative or guardian has been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent Form prior to any premedication, prior to performance of revascularization procedures, and prior to participation in any study-related activities
排除标准
- •Women of child bearing potential who do not use adequate contraception
- •Patients who have experienced acute onset of claudication
- •History of bleeding diathesis, coagulopathy, platelet disorder, or thrombocytopenia
- •Patients with lesions requiring treatment with atherectomy or primary stenting
- •Target lesion in which PTA failure would require treatment by provisional stenting with more than 2 stents
- •Patient has a life expectancy of less than 36 months or there are factors making clinical follow up difficult (no fixed address, etc)
- •Additional planned vascular procedure in treated extremity (note that concurrent endovascular treatment of iliac disease is allowable)
- •Patient is immunosuppressed or is HIV positive
- •Any individual who may refuse a blood transfusion
- •Documented major gastrointestinal bleeding within 3 months
- •The following lab values at baseline are exclusionary:
- •Serum creatinine greater or equal to 2.5 mg/dl
- •Platelet count less than 100,000 cells/mm^3
- •Uncorrectable coagulopathy with international normalized ratio (INR) greater than 2.0
- •Absolute Neutrophil Count (ANC) less than 2000 cells mm^3
- •Hemoglobin (Hgb) less than 9 g/dl
- •Total Bilirubin greater than 1.5 mg/dl
- •Alanine transaminase (SGPT) greater than 2.5 x upper limit normal range (ULN)
- •Aspartate transaminase (SGOT) greater than 2.5 x ULN
- •Alkaline phosphatase greater than 2.5 x ULN
- •Total cholesterol greater than 350 mg/dl or Low Density Lipoprotein greater than 200 mg/dl
- •Known allergies/hypersensitivity/contraindication to the study drug, to taxanes, to any required study treatment:aspirin, heparin, clopidogrel bisulfate, stent materials, or to ticlopidine, or dipyridamole
- •Patient treated with bivalirudin (Angiomax)
- •Pre-existing sensory neuropathy of National Cancer Institute (NCI) Toxicity Grade >1
- •Previous participation in another study with any investigational drug or device within the past 30 days or current enrollment in any other clinical protocol or investigational trial
- •Renal failure requiring hemodialysis
- •Lower extremity or pedal pulse
研究组 & 干预措施
Proximal to Lesion + IV
Experimental
Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
干预措施: Nanoparticle Paclitaxel (Drug)
During Flow Arrest
Experimental
Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
干预措施: Nanoparticle Paclitaxel (Drug)
During Flow Arrest + IV
Experimental
Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
干预措施: Nanoparticle Paclitaxel (Drug)
结局指标
主要结局
Target Vessel Revascularization at 9 Months
时间窗: 9 months
Target vessel revascularization (TVR) was defined as percutaneous revascularization or bypass of the target lesion or any segment of the artery containing the target lesion. The percentage of participants requiring revascularization of the target vessel was determined by stenosis of \> 50% confirmed by angiography.
次要结局
- Minimum Lumen Diameter(9 months)
- Systolic Velocity Ratio (SVR) > 2.0(9 months)
- Change From Baseline in Walking Impairment Questionnaire (WIQ) Score(Baseline and Month 9)
- Decrease in Ankle Brachial Index (ABI) > 0.15(Baseline and Month 9)
- Target Lesion Revascularization (TLR) at 9 Months(9 months)
- Number of Deaths(Up to 11 months)
- Number of Participants With Myocardial Infarction (MI)(Up to 11 months)
- Number of Participants With a Stroke(Up to 11 months)
- Late Loss(Day 1 (following revascularization) and 9 months)
- Percentage of Participants With Binary Restenosis(9 months)
- Diameter Stenosis(9 months)
研究者
研究点 (7)
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