Lower Limb Ischemia Clinical Trial
Official title:
MulticentRe pOst-market exPeriencE With the INdigo Thrombectomy System for the Treatment of Acute Lower Limb Ischaemia : (Re-Open Registry)
International Multi-Centre registry recording comprehensive data on the use of 'Indigo' Mechanical thrombectomy system by Penumbra Inc for the removal of acute clot causing acute or critical limb ischaemia.
A detailed registry has been designed and approved to be used world wide in vascular and
trauma centres, already providing endovascular service for the management of critical limb
ischaemia (CLI).
Recent campaigns have shown little is done to improve flow to the lower limbs (legs) of
patients to avoid amputation rates. During this time many devises have been used and
available on the market. The 'Indigo' system by Penumbra was originally designed from the
acute stroke system "ACE". Similar principles were applied in designing the 'Indigo' system.
This is currently being used in many centres to manage acute clot causing lower limb
ischaemia, however no official registry or international clinical trial has been done to show
its significance in managing this disease.
The investigator groups, have created this to come up with enough data to evaluate the Indigo
system in the management of (ALI) and offer tips and tricks to other clinicians. The aim is
for a single arm, multicenter, retrospective analysis of patients in whom (ALI) was performed
with the Penumbra/Indigo System (study device), and gather greater data and information than
the PRISM trial in 2013-2014 which obtained only 79 patients.
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