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

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ClinicalTrials.gov Identifier: NCT03295539
Recruitment Status : Unknown
Verified October 2017 by Bella Huasen, Lancashire Care NHS Foundation Trust.
Recruitment status was:  Not yet recruiting
First Posted : September 28, 2017
Last Update Posted : October 20, 2017
Sponsor:
Collaborator:
St. Franziskus Hospital
Information provided by (Responsible Party):
Bella Huasen, 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.

Condition or disease Intervention/treatment Phase
Lower Limb Ischemia Device: 'Indigo' Mechanical thrombectomy system Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: MulticentRe pOst-market exPeriencE With the INdigo Thrombectomy System for the Treatment of Acute Lower Limb Ischaemia : (Re-Open Registry)
Estimated Study Start Date : November 1, 2017
Estimated Primary Completion Date : October 1, 2018
Estimated Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Acute or Chronic clot
If chronic clot, no intervention given via Indigo
Device: 'Indigo' Mechanical thrombectomy system
Removal of acute clot from the artery causing ischaemia, using the mechanical aspiration system by Penumbra Inc called "INDIGO"




Primary Outcome Measures :
  1. Technical success using the Indigo system. [ Time Frame: 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.




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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acute lower limb Ischaemia with acute soft clot.

Exclusion Criteria:

  • Calcified plaques/ chronic disease causing critical limb Ischaemia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03295539


Contacts
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Contact: Bella Huasen, MD 00447871800565 doctorbella.h@gmail.com
Contact: Theo Bisdas, Phd, MD 00492519355829 th.bisdas@gmail.com

Locations
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United Kingdom
Interventional Radiology
Preston, Lancashire, United Kingdom, PR2 7HR
Contact: BELLA HUASEN, MD    00447871800565    doctorbella.h@gmail.com   
Sponsors and Collaborators
Lancashire Care NHS Foundation Trust
St. Franziskus Hospital
Investigators
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Study Chair: Bella Huasen, MD Lancashire NHS
Publications of Results:
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Responsible Party: Bella Huasen, Endovascular Interventional Consultant, Lancashire Care NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03295539    
Other Study ID Numbers: Indigo2017
First Posted: September 28, 2017    Key Record Dates
Last Update Posted: October 20, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The registry and data in-put
Supporting Materials: Study Protocol
Time Frame: while the study is on-going
Access Criteria: Centres taking part will be given the access via the three main trial investigators Dr Huasen, Dr Bisdas, and Dr Beropoulis

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Ischemia
Pathologic Processes