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

Lancashire Care NHS Foundation Trust

Status: Unknown

Conditions: Lower Limb Ischemia

Treatments: Device: 'Indigo' Mechanical thrombectomy system

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT03295539

Indigo2017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Acute lower limb Ischaemia with acute soft clot.

Exclusion criteria

• Calcified plaques/ chronic disease causing critical limb Ischaemia

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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400 participants in 1 patient group

Acute or Chronic clot

Other group

Description:

If chronic clot, no intervention given via Indigo

Treatment:

Device: 'Indigo' Mechanical thrombectomy system