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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03388021

Enrollment

Registered

2018-01-02

Start date

2015-03-02

Completion date

2018-02-04

Last updated

2018-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Limb Ischemia

Keywords

limb ischemia, completion angiography, thromboembolectomy

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

Interventions

PROCEDUREcompletion 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
complication rates	2 years after operation

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026