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

Acute Limb Ischemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03388021
• Other study ID #: MD/85
• Status: Completed
• Phase: N/A
• First received: December 23, 2017
• Last updated: March 22, 2018
• Start date: March 2, 2015
• Est. completion date: February 4, 2018

Study information

• Verified date: March 2018
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: February 4, 2018
• Est. primary completion date: February 4, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Limb Ischemia
• Ischemia

Intervention

Procedure:
• completion angiography followed by endovascular treatment of residual or underlying lesions
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

Locations

Country	Name	City	State
Egypt	Mansoura University Hospitals	Mansourah	Al Dakhlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

References & Publications (6)

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. — View 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 — View 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. Review. — View 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. Review. — View 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. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	limb salvage rate	free from major amputation	2 years after operation
Primary	primary patency	free from reintervention	2 years after operation
Primary	mortality rate	death related from the intervention	30 days after operation
Secondary	complication rates		2 years after operation