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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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ClinicalTrials.gov Identifier: NCT03388021
Recruitment Status : Completed
First Posted : January 2, 2018
Last Update Posted : March 23, 2018
Sponsor:
Information provided by (Responsible Party):
Amr Elshafie, Mansoura University

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

Condition or disease Intervention/treatment Phase
Acute Limb Ischemia Procedure: completion angiography followed by endovascular treatment of residual or underlying lesions Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Routine Versus Selective Completion Angiography After Thromboembolectomy in the Treatment of Acute Lower Limb Ischemia: A Randomized Controlled Trial
Actual Study Start Date : March 2, 2015
Actual Primary Completion Date : February 4, 2018
Actual Study Completion Date : February 4, 2018

Arm Intervention/treatment
Experimental: routine use of completion angiography after thromboembolectomy

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
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

Active Comparator: if the results were not satisfactory intraoperatively as fail
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.
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




Primary Outcome Measures :
  1. limb salvage rate [ Time Frame: 2 years after operation ]
    free from major amputation

  2. primary patency [ Time Frame: 2 years after operation ]
    free from reintervention

  3. mortality rate [ Time Frame: 30 days after operation ]
    death related from the intervention


Secondary Outcome Measures :
  1. complication rates [ Time Frame: 2 years after operation ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03388021


Locations
Egypt
Mansoura University Hospitals
Mansourah, Al Dakhlia, Egypt, 35516
Sponsors and Collaborators
Mansoura University

Publications of Results:
Other Publications:
Responsible Party: Amr Elshafie, Assistant Lecturer of vascular surgery, Mansoura University
ClinicalTrials.gov Identifier: NCT03388021     History of Changes
Other Study ID Numbers: MD/85
First Posted: January 2, 2018    Key Record Dates
Last Update Posted: March 23, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Amr Elshafie, Mansoura University:
limb ischemia
completion angiography
thromboembolectomy

Additional relevant MeSH terms:
Ischemia
Pathologic Processes