A Trial Comparing Routine Versus Selective Use of Completion Angiography After Surgical Thromboembolectomy in the Treatment of Acute Lower Limb Ischemia and Their Impacts on Limb Salvage Rates

Study Overview
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Brief Summary
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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

Official Title
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Routine Versus Selective Completion Angiography After Thromboembolectomy in the Treatment of Acute Lower Limb Ischemia: A Randomized Controlled Trial

Conditions
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Acute Limb Ischemia

Intervention / Treatment
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* Procedure: completion angiography followed by endovascular treatment of residual or underlying lesions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: routine use of completion angiography after thromboembolectomy<br>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 | Procedure: completion angiography followed by endovascular treatment of residual or underlying lesions<br>* completion angiography followed by endovascular treatment as thromboembolectomy under fluoroscopic guidance using Fogarty over the wire, angioplasty, stenting, or Intraarterial thrombolysis to treat residual or underlying lesions<br>|
| Active Comparator: if the results were not satisfactory intraoperatively as fail<br>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. | Procedure: completion angiography followed by endovascular treatment of residual or underlying lesions<br>* completion angiography followed by endovascular treatment as thromboembolectomy under fluoroscopic guidance using Fogarty over the wire, angioplasty, stenting, or Intraarterial thrombolysis to treat residual or underlying lesions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| limb salvage rate | free from major amputation | 2 years after operation | 
| primary patency | free from reintervention | 2 years after operation | 
| mortality rate | death related from the intervention | 30 days after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complication rates |  | 2 years after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thromboembolectomy, limb ischemia, completion angiography