Randomized Clinical Trial in Bellow-the-knee Angioplasty. Treatment of One or More Than One Artery.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Time of wound healing
研究概览
简要总结
It is a randomized study that intend to enroll 80 bellow-the-knee angioplasty procedures in which 40 procedures to treat one artery (standart) or more than one artery in the same procedure.
The aim of this study is to know if this strategy increase healing velocity and limb salvage.
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
- Single (Participant)
盲法说明
The moment of randomization was after the successful accomplish of the recanalizaripn of the first artery. The used 80 sealed papers - 40 for each treatment. The nurse pick up one of the mixed papers and the procedure stops or continuous to the another artery depending on the randomization.
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
- •Occlusion of the three arteries bellow the knee previously
- •Rutherford 5 - ischemic lesion of the foot
- •Informative Term
- •At least one patente vessel in pedal arch
排除标准
- •allergy to aspirin, clopidogrel or contrast media
- •renal impairment
- •Tasc D lesion in femoral or popliteal arteries
- •no undersatnting patients
研究组 & 干预措施
One Artery
In this arm after obtain the good result after the angioplasty of one artery the procedure stops
干预措施: Angioplasty of distal arteries (Procedure)
More than one artery
In this arm, after obtain a good result of the angioplasty of one artery, we continue trying one or two more arteries
干预措施: Angioplasty of distal arteries (Procedure)
结局指标
主要结局
Time of wound healing
时间窗: 1 year
Time in days necessary to the complete healing of the wound
Limb Salvage
时间窗: 1 year
Time free of major amputation
次要结局
未报告次要终点
研究者
Rodrigo Bruno Biagioni
Dr
Federal University of São Paulo