Acute Limb IschemiaNCT03388021
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
A study testing completion angiography followed by endovascular treatment of residual or underlying lesions in people with Acute Limb Ischemia, run by Mansoura University at 1 site in Egypt.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Limb Ischemia
- What is being tested?
- completion angiography followed by endovascular treatment of residual or underlying lesions
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Mar 2015to 4 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Routine Versus Selective Completion Angiography After Thromboembolectomy in the Treatment of Acute Lower Limb Ischemia: A Randomized Controlled Trial
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
- Conditions
- Acute Limb Ischemia
- Being tested
- completion angiography followed by endovascular treatment of residual or underlying lesions
- Keywords
- limb ischemia, completion angiography, thromboembolectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
completion angiography followed by endovascular treatment of residual or underlying lesionsProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| routine use of completion angiography after thromboembolectomy | Experimental | 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 Receives: Procedure: completion angiography followed by endovascular treatment of residual or underlying lesions |
| if the results were not satisfactory intraoperatively as fail | Active comparator | 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. Receives: Procedure: completion angiography followed by endovascular treatment of residual or underlying lesions |
What is being measured
The primary outcome is the main question the study is designed to answer.
limb salvage rate
free from major amputation
Measured: 2 years after operation
primary patency
free from reintervention
Measured: 2 years after operation
mortality rate
death related from the intervention
Measured: 30 days after operation
Secondary outcomes (1)
complication rates
Measured: 2 years after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2018
- Study start2 Mar 2015
- Primary completion4 Feb 2018
- Study completion4 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Acute Limb IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Elshafie, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03388021
- Sponsor's protocol ID
- MD/85
- Status last verified
- Mar 2018
- First submitted
- 23 Dec 2017
- Last updated
- 23 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 19298929Ouriel 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.
PubMed 14691769Zaraca 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.
PubMed 20363108Zaraca 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.
PubMed 22743219de 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.
PubMed 24342067Argyriou 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.
PubMed 24530573
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Routine Versus Selective Completion Angiography After Thromboembolectomy in the Treatment of Acute Lower Limb Ischemia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03388021
- Acronym / sponsor ID
- MD/85
- Conditions
- Acute Limb Ischemia
- Keywords
- limb ischemia, completion angiography, thromboembolectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 2 Mar 2015 (actual)
- Primary completion
- 4 Feb 2018 (actual)
- Study completion
- 4 Feb 2018 (actual)
- First posted
- 2 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| routine use of completion angiography after thromboembolectomy | Experimental | Procedure: completion angiography followed by endovascular treatment of residual or underlying lesionsthis 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 | Active comparator | Procedure: completion angiography followed by endovascular treatment of residual or underlying lesionsthis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| completion angiography followed by endovascular treatment of residual or underlying lesionscompletion 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 | Procedure or surgery | if the results were not satisfactory intraoperatively as fail, routine use of completion angiography after thromboembolectomy |
Primary outcome
limb salvage rate
Time frame: 2 years after operation
free from major amputation
primary patency
Time frame: 2 years after operation
free from reintervention
mortality rate
Time frame: 30 days after operation
death related from the intervention
1 secondary outcome
complication rates
Time frame: 2 years after operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2018.
- Background: PubMed 19298929Rutherford 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.
- Background: PubMed 14691769Ouriel 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 publication: PubMed 20363108Zaraca 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 publication: PubMed 22743219Zaraca 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 publication: PubMed 24342067de 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 publication: PubMed 24530573Argyriou 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing completion angiography followed by endovascular treatment of residual or underlying lesions in people with Acute Limb Ischemia, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
limb salvage rate (time frame: 2 years after operation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03388021, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2018.