Sealing Moderate Coronary Saphenous VEin Graft LEsions With the Paclitaxel-eluting Stent (Taxus) as a New Approach to Maintain Vein Graft Patency and Reduce Cardiac Events: a Pilot Intravascular Ultrasound Study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Ultrasound lumen area and minimal lumen diameter at follow-up at the tomographic section showing the most severe stenosis, comparing stented vs medically treated SVGs lesions
研究概览
简要总结
HYPOTHESIS
- Sealing moderate SVG lesions with the TAXUS stent prevents SVG atherosclerosis progression as evaluated by IVUS.
- Sealing moderate SVG lesions with the TAXUS stent does not accelerate SVG atherosclerosis in the angiographically non-diseased segments of the SVG as evaluated by IVUS.
OBJECTIVES
- To determine the effect of stenting moderate SVG lesions with the paclitaxel-eluting stent in comparison with medical treatment on limiting SVG disease progression as evaluated by IVUS.
- To evaluate by IVUS the effect of stenting moderate SVG lesions with the paclitaxel-eluting stent in comparison with medical treatment on atherosclerosis progression in angiographically non-diseased SVGs segments.
详细描述
This will be a prospective randomized study assessing the efficacy of stenting moderate SVG lesions with the taxus stent in the prevention of atherosclerosis progression of SVGs as evaluated by IVUS. Patients with previous coronary bypass surgery with SVG implantation undergoing coronary angiography by clinical indication will be screened. If the patient has a moderate lesion at any level of the SVGs it will be includable in the study. After inclusion, the patients will be randomized to either stenting the moderate SVG lesion with the taxus stent or standard medical treatment. The use of a filter wire during dilation will be strongly recommended. Following this procedure, all patients will have clinical controls at 1 month and at 6 months and an angiographic and IVUS control study at 1 year follow-up.
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
- •Written and signed informed consent.
- •Patients ≥18 years old.
- •Clinical indication for cardiac catheterization and SVG angiography.
- •Presence of at least one SVG lesion of 30% to 70% diameter stenosis by visual estimation which is (are) not the culprit lesion (s) responsible for the clinical syndrome of the patient.
排除标准
- •Ejection fraction <20%.
- •Renal insufficiency with creatinine > 250 mg/dl.
- •Presence of more than 3 moderate SVG stenosis or significant diffuse SVG disease.
- •Unsuccessful angioplasty (residual stenosis >30% and/or TIMI flow <3) of any other lesion treated during the same procedure.
- •Coronary angioplasty of the target SVG in the past.
- •Cardiogenic shock .
- •Remaining lesion (s) with a treatment planned within the following year.
- •Pregnancy.
- •Contraindication to aspirin and/or clopidogrel treatment.
- •Allergy to paclitaxel.
- •Any disease with a limiting life-expectancy (to less than 2 years).
- •Definite presence or high suspicion of thrombus or ulceration in the target lesion.
- •Target lesion located in the same SVG than the culprit lesion (if present) and the distance between the target lesion and the most proximal or distal part of the stent implanted at the culprit lesion is < 4 cm.
- •Vein graft diameter < 2.5 mm.
结局指标
主要结局
Ultrasound lumen area and minimal lumen diameter at follow-up at the tomographic section showing the most severe stenosis, comparing stented vs medically treated SVGs lesions
时间窗: 12 months
Change between baseline and follow-up in ultrasound lumen area and minimal lumen diameter (% and absolute value) at the tomographic section showing the most severe stenosis, comparing stented vs medically treated SVGs lesions
时间窗: 12 months
Change in atheroma volume (% and absolute value) as evaluated by IVUS between baseline and follow-up in an angiographically non-diseased 40 mm segment (excluding the target lesion), comparing stented vs medically treated SVGs
时间窗: 12 months
次要结局
- Cumulative incidence of clinical events (cardiovascular death, myocardial infarction, repeat revascularization) at 12 months follow-up(12 months)
- SVG occlusion rate, lesion/stent late loss, minimal lumen diameter, and % diameter stenosis as assessed by angiography at 12 months follow-up(12 months)