Acute Limb Ischaemia (ALI) Management With 'Indigo' Mechanical Aspiration System
NCT ID: NCT03295539
Last Updated: 2017-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
400 participants
INTERVENTIONAL
2017-11-01
2019-03-01
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Acute or Chronic clot
If chronic clot, no intervention given via Indigo
'Indigo' Mechanical thrombectomy system
Removal of acute clot from the artery causing ischaemia, using the mechanical aspiration system by Penumbra Inc called "INDIGO"
Interventions
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'Indigo' Mechanical thrombectomy system
Removal of acute clot from the artery causing ischaemia, using the mechanical aspiration system by Penumbra Inc called "INDIGO"
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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St. Franziskus Hospital
OTHER
Lancashire Care NHS Foundation Trust
NETWORK
Responsible Party
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Bella Huasen
Endovascular Interventional Consultant
Principal Investigators
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Bella Huasen, MD
Role: STUDY_CHAIR
Lancashire NHS
Locations
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Interventional Radiology
Preston, Lancashire, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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BELLA HUASEN, MD
Role: primary
References
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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):1123-36. doi: 10.1007/s00270-011-0258-z. Epub 2011 Sep 1.
Other Identifiers
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Indigo2017
Identifier Type: -
Identifier Source: org_study_id