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

Not Applicable

Completed

• Conditions: Acute Limb Ischemia
• Interventions: Procedure: completion angiography followed by endovascular treatment of residual or underlying lesions

• Registration Number: NCT03388021
• Lead Sponsor: Mansoura University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-02
• Study First Submitted: 2017-12-23
• Study First Submitted QC: 2017-12-29
• Study First Posted: 2018-01-02
• Primary Completion: 2018-02-04
• Study Completion: 2018-02-04
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-22
• Last Update Posted: 2018-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
routine use of completion angiography after thromboembolectomy	completion angiography followed by endovascular treatment of residual or underlying lesions	this group will undergo surgical revascularization followed by routine completion angiography assisted with one of these adjuvant techniques as: 1. Thromboembolectomy under fluoroscopic guidance using Fogarty over the wire 2. Balloon angioplasty and/or stenting 3. Intraarterial thrombolysis Aiming to correct any residual angiographic lesion as: 1. Residual thrombus 2. Retained embolus 3. Atheromatous plaque
if the results were not satisfactory intraoperatively as fail	completion angiography followed by endovascular treatment of residual or underlying lesions	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.

Primary Outcome Measures

Name	Time	Method
mortality rate	30 days after operation	death related from the intervention
limb salvage rate	2 years after operation	free from major amputation
primary patency	2 years after operation	free from reintervention

Secondary Outcome Measures

Name	Time	Method
complication rates	2 years after operation

Trial Locations

Locations (1)

Mansoura University Hospitals; 🇪🇬 Mansourah, Al Dakhlia, Egypt