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
150 participants
INTERVENTIONAL
2017-09-01
2019-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment by "Indigo" mechanical thrombectomy system
Acute or Chronic clot: if chronic (\> 14 days) no intervention given via Indigo
"Indigo" Mechanical Thrombectomy System
Removal of acute clot (\< 14 days) from the artery causing lower limb ischemia, using the "Indigo" System by Penumbra
Interventions
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"Indigo" Mechanical Thrombectomy System
Removal of acute clot (\< 14 days) from the artery causing lower limb ischemia, using the "Indigo" System by Penumbra
Eligibility Criteria
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Inclusion Criteria
* Patient presenting a score from I to IIb following Rutherford classification for acute limb ischemia
* Patient is willing to comply with specified follow-up evaluations at the specified times for the duration of the study
* Patient is \>18 years old
* Patient (or their legal representative) understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
* Patient is eligible for treatment with the Indigo System (Penumbra)
Exclusion Criteria
* Patients refusing treatment
* Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated
* Patients with a history of prior life-threatening contrast medium reaction
* Life expectancy of less than six months
* Any patient considered to be hemodynamically unstable at onset of procedure
18 Years
ALL
No
Sponsors
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Azienda Ospedaliera Universitaria Senese
OTHER
Responsible Party
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Carlo Setacci, Gianmarco de Donato
University of Siena
Locations
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Vascular Surgery, University of Siena
Siena, , Italy
Countries
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Central Contacts
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Facility Contacts
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Gianmarco de Donato, MD
Role: primary
References
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Yamada R, Adams J, Guimaraes M, Schonholz C. Advantages to Indigo mechanical thrombectomy for ALI: device and technique. J Cardiovasc Surg (Torino). 2015 Jun;56(3):393-400. Epub 2015 Feb 3.
Other Identifiers
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Indian001
Identifier Type: -
Identifier Source: org_study_id
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