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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

Primary Purpose

Acute Limb Ischemia

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

completion angiography followed by endovascular treatment of residual or underlying lesions

About this trial

This is an interventional treatment trial for Acute Limb Ischemia focused on measuring limb ischemia, completion angiography, thromboembolectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Mansoura University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

routine use of completion angiography after thromboembolectomy

if the results were not satisfactory intraoperatively as fail

Arm Description

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

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.

Outcomes

Primary Outcome Measures

limb salvage rate

free from major amputation

primary patency

free from reintervention

mortality rate

death related from the intervention

Secondary Outcome Measures

complication rates

Full Information

NCT ID

NCT03388021

First Posted

December 23, 2017

Last Updated

March 22, 2018

Sponsor

Mansoura University

1. Study Identification

Unique Protocol Identification Number

NCT03388021

Brief Title

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

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

March 2, 2015 (Actual)

Primary Completion Date

February 4, 2018 (Actual)

Study Completion Date

February 4, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Limb Ischemia

Keywords

limb ischemia, completion angiography, thromboembolectomy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

92 (Actual)

8. Arms, Groups, and Interventions

Arm Title

routine use of completion angiography after thromboembolectomy

Arm Type

Experimental

Arm Description

Arm Title

if the results were not satisfactory intraoperatively as fail

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

completion angiography followed by endovascular treatment of residual or underlying lesions

Intervention Description

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

Primary Outcome Measure Information:

Title

limb salvage rate

Description

free from major amputation

Time Frame

2 years after operation

Title

primary patency

Description

free from reintervention

Time Frame

2 years after operation

Title

mortality rate

Description

death related from the intervention

Time Frame

30 days after operation

Secondary Outcome Measure Information:

Title

complication rates

Time Frame

2 years after operation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Mansoura University Hospitals

City

Mansourah

State/Province

Al Dakhlia

ZIP/Postal Code

35516

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

19298929

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.

Results Reference

background

PubMed Identifier

14691769

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.

Results Reference

background

PubMed Identifier

20363108

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.

Results Reference

result

PubMed Identifier

22743219

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.

Results Reference

result

PubMed Identifier

24342067

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.

Results Reference

result

PubMed Identifier

24530573

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.

Results Reference

result

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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

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