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

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03295539
• Other study ID #: Indigo2017
• Status: Not yet recruiting
• Phase: N/A
• First received: September 6, 2017
• Last updated: October 19, 2017
• Start date: November 1, 2017
• Est. completion date: March 1, 2019

Study information

• Verified date: October 2017
• Source: Lancashire Care NHS Foundation Trust
• Contact: Bella Huasen, MD
• Phone: 00447871800565
• Email: doctorbella.h[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: March 1, 2019
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Acute lower limb Ischaemia with acute soft clot.

Exclusion Criteria:

• Calcified plaques/ chronic disease causing critical limb Ischaemia

Related Conditions & MeSH terms

• Ischemia
• Lower Limb Ischemia

Intervention

Device:
• 'Indigo' Mechanical thrombectomy system
Removal of acute clot from the artery causing ischaemia, using the mechanical aspiration system by Penumbra Inc called "INDIGO"

Locations

Country	Name	City	State
United Kingdom	Interventional Radiology	Preston	Lancashire

Sponsors (2)

Lead Sponsor	Collaborator
Lancashire Care NHS Foundation Trust	St. Franziskus Hospital

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Karnabatidis D, Spiliopoulos S, Tsetis D, Siablis D. Quality improvement guidelines for percutaneous catheter-directed intra-arterial thrombolysis and mechanical thrombectomy for acute lower-limb ischemia. Cardiovasc Intervent Radiol. 2011 Dec;34(6):1123- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technical success using the Indigo system.	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.	Time to event anaylsis. Primary patency results are immediate after the case on the final angiogram images.