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

Not Applicable

• Conditions: Lower Limb Ischemia
• Interventions: Device: 'Indigo' Mechanical thrombectomy system

• Registration Number: NCT03295539
• Lead Sponsor: Lancashire Care NHS Foundation Trust

Brief 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.

Study Timeline

• Study First Submitted: 2017-09-06
• Study First Submitted QC: 2017-09-24
• Study First Posted: 2017-09-28
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-19
• Last Update Posted: 2017-10-20
• Study Start: 2017-11-01
• Primary Completion: 2018-10-01
• Study Completion: 2019-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Acute lower limb Ischaemia with acute soft clot.

Exclusion Criteria

• Calcified plaques/ chronic disease causing critical limb Ischaemia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acute or Chronic clot	'Indigo' Mechanical thrombectomy system	If chronic clot, no intervention given via Indigo

Primary Outcome Measures

Name	Time	Method
Technical success using the Indigo system.	Time to event anaylsis. Primary patency results are immediate after the case on the final angiogram images.	Intraoperative technical success defined as the restoration of antegrade blood flow with complete or near complete (95% by volume) removal of the thrombus or embolus (70% threshold). This is assessed using imaging modalities (USS/Doppler/Fluroscopy) and clinical assessment of the affected limb.; See for this definition the enclosed citation. In conclusion, the primary outcome measure will be improvement in blood flow across a lesion assessed by the improvement in Thrombolysis in Myocardial Infarction (TIMI) score that was adapted to peripheral arteries. Concomitant balloon angioplasty or stent placement in addition to VAT was considered a complementary treatment. Additional thrombectomy treatments, such as thrombolysis and mechanical thrombectomy, were considered technical failures.Target lesions were grouped anatomically into above-the-knee(ATK) or below-the-knee(BTK) lesions.

Trial Locations

Locations (1)

Interventional Radiology; 🇬🇧 Preston, Lancashire, United Kingdom