Status:
UNKNOWN
The Indigo System in Acute Lower Limb Malperfusion
Lead Sponsor:
Azienda Ospedaliera Universitaria Senese
Conditions:
Acute Ischemia of Lower Limb
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To evaluate, in a controlled setting, the early safety and effectiveness of the Penumbra/Indigo aspiration thrombectomy Systems (San Francisco, California), and to define optimal technique for the use...
Eligibility Criteria
Inclusion
- Patients will be selected based on the investigator's assessment and evaluation of the underlying disease.
- The patient's medical condition should be stable, with no underlying medical condition that would prevent them from performing the required testing or from completing the study.
- Patients should be geographically stable, willing and able to cooperate in this clinical study, and remain available for mid term follow-up. Patients who do not wish to participate in this study can obtain any other standard commercially available device therapy. Refusal to participate in this study will in no way affect their care at the institution.
- Inclusion Criteria
- Patient presenting with an acute occlusion of lower limb arteries (thrombosis no longer than 14 days)
- 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
- Estimated time of intraluminal thrombus \> 14 days
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2019
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03386370
Start Date
September 1 2017
End Date
May 1 2019
Last Update
January 10 2019
Active Locations (1)
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1
Vascular Surgery, University of Siena
Siena, Italy, 53100