Routine Versus Selective Completion Angiography After Thromboembolectomy in the Treatment of Acute Lower Limb Ischemia: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- mortality rate
研究概览
简要总结
this randomized controlled trial will compare the impact of routine use of completion angiography versus using it on selective bases after thromboembolectomy in patients with acute lower limb ischemia and their impact on limb salvage rates
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
- •Grade I (1) (viable) acute ischemia which there is no immediate threat of limb loss; the patient is presented with neither sensory nor motor weakness and there are audible Doppler signals in both arteries and veins.
- •Grade IIA (2 A) (marginally threatened) acute ischemia which needs proper treatment to save the limb; the patient is presented with a minimal sensory loss, no motor weakness, inaudible arterial Doppler signals but the venous Doppler signals are still audible.
- •Grade IIB (2 B) (immediately threatened) acute ischemia which needs immediate revascularization to save the limb; the patient is presented with a sensory loss associated with rest pain, mild to moderate motor weakness, inaudible arterial Doppler signals but the venous Doppler signals are still audible.
排除标准
- •Traumatic or iatrogenic acute limb ischemia
- •Grade III acute ischemia (irreversible) with major tissue loss and major amputation is inevitable; the patient presented with sensory and motor loss, inaudible arterial and venous Doppler signals.
- •Patients With occluded bypass graft.
- •Acute limb ischemia due to intra-arterial injection
- •Patients with chronic renal impairment (serum creatinine > 1.2) or with a history of contrast-induced nephropathy.
- •Acute lower limb ischemia due to thrombosed aneurysms
研究组 & 干预措施
routine use of completion angiography after thromboembolectomy
this group will undergo surgical revascularization followed by routine completion angiography assisted with one of these adjuvant techniques as:
- Thromboembolectomy under fluoroscopic guidance using Fogarty over the wire
- Balloon angioplasty and/or stenting
- Intraarterial thrombolysis
Aiming to correct any residual angiographic lesion as:
- Residual thrombus
- Retained embolus
- Atheromatous plaque
干预措施: completion angiography followed by endovascular treatment of residual or underlying lesions (Procedure)
if the results were not satisfactory intraoperatively as fail
this group will undergo surgical thromboembolectomy. if the results were not satisfactory intraoperatively as failure to advance the Fogarty catheter or to get satisfactory inflow or backflow or Extraction of intimal fragments.patient will undergo diagnostic angiography and endovascular or surgical intervention according to result of diagnostic angiography.
干预措施: completion angiography followed by endovascular treatment of residual or underlying lesions (Procedure)
结局指标
主要结局
mortality rate
时间窗: 30 days after operation
death related from the intervention
limb salvage rate
时间窗: 2 years after operation
free from major amputation
primary patency
时间窗: 2 years after operation
free from reintervention
次要结局
- complication rates(2 years after operation)
研究者
Amr Elshafie
Assistant Lecturer of vascular surgery
Mansoura University