NCT03295539

Acute Limb Ischaemia (ALI) Management With 'Indigo' Mechanical Aspiration System

MulticentRe pOst-market exPeriencE With the INdigo Thrombectomy System for the Treatment of Acute Lower Limb Ischaemia : (Re-Open Registry)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Lancashire Care NHS Foundation Trust · Network
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Lower Limb Ischemia

Interventions

Type	Name	Description
DEVICE	'Indigo' Mechanical thrombectomy system	Removal of acute clot from the artery causing ischaemia, using the mechanical aspiration system by Penumbra Inc called "INDIGO"

Timeline

• Start date: 2017-11-01
• Primary completion: 2018-10-01
• Completion: 2019-03-01
• First posted: 2017-09-28
• Last updated: 2017-10-20

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated device study