Clinical trial NCT03388021: 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
Official title: Routine Versus Selective Completion Angiography After Thromboembolectomy in the Treatment of Acute Lower Limb Ischemia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Limb Ischemia
Keywords: limb ischemia
completion angiography
thromboembolectomy
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2018-01-02
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: limb salvage rate
timeFrame: 2 years after operation
measure: primary patency
timeFrame: 2 years after operation
measure: mortality rate
timeFrame: 30 days after operation
Secondary outcomes:
measure: complication rates
timeFrame: 2 years after operation
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Mansoura University Hospitals
state: Al Dakhlia
Study officials:
References:
citation: Rutherford RB. Clinical staging of acute limb ischemia as the basis for choice of revascularization method: when and how to intervene. Semin Vasc Surg. 2009 Mar;22(1):5-9. doi: 10.1053/j.semvascsurg.2008.12.003.
citation: Ouriel K. Endovascular techniques in the treatment of acute limb ischemia: thrombolytic agents, trials, and percutaneous mechanical thrombectomy techniques. Semin Vasc Surg. 2003 Dec;16(4):270-9. doi: 10.1053/j.semvascsurg.2003.08.004.
citation: Zaraca F, Stringari C, Ebner JA, Ebner H. Routine versus selective use of intraoperative angiography during thromboembolectomy for acute lower limb ischemia: analysis of outcomes. Ann Vasc Surg. 2010 Jul;24(5):621-7. doi: 10.1016/j.avsg.2009.12.006. Epub 2010 Apr 2.
citation: Zaraca F, Ponzoni A, Sbraga P, Stringari C, Ebner JA, Ebner H. Does routine completion angiogram during embolectomy for acute upper-limb ischemia improve outcomes? Ann Vasc Surg. 2012 Nov;26(8):1064-70. doi: 10.1016/j.avsg.2011.12.012. Epub 2012 Jun 26.
citation: de Donato G, Setacci F, Sirignano P, Galzerano G, Massaroni R, Setacci C. The combination of surgical embolectomy and endovascular techniques may improve outcomes of patients with acute lower limb ischemia. J Vasc Surg. 2014 Mar;59(3):729-36. doi: 10.1016/j.jvs.2013.09.016. Epub 2013 Dec 15.
citation: Argyriou C, Georgakarakos E, Georgiadis GS, Antoniou GA, Schoretsanitis N, Lazarides M. Hybrid revascularization procedures in acute limb ischemia. Ann Vasc Surg. 2014 Aug;28(6):1456-62. doi: 10.1016/j.avsg.2014.01.019. Epub 2014 Feb 11.