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 of these systems in patients with confirmed peripheral acute occlusions.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Removal of acute clot (\< 14 days) from the artery causing lower limb ischemia, using the "Indigo" System by Penumbra
Vascular Surgery, University of Siena
Siena, Italy
RECRUITINGTechnical success of the thromboaspiration with the Indigo system.
The primary endpoint of the study is the technical success of the thromboaspiration with the Indigo system. Assessment of vessel patency will be recorded using the Thrombolysis in Myocardial Infarction (TIMI) score classifications both before and after use of the device.
Time frame: At intra-procedural completion angiography
Clinical success at 1 month follow-up.
Clinical success at follow-up is defined as an improvement of Rutherford classification at 1-month follow-up of one class or more as compared to the pre-procedure Rutherford classification.
Time frame: 1 month
Safety Rate at discharge: Serious adverse event.
Safety rate at discharge, defined as absence of any serious adverse events (SAE). A SAE is defined as any clinical event that is fatal, life-threatening, or judged to be severe by the investigator; resulted in persistent or significant disability.
Time frame: 1 month
Primary Patency
Primary patency at 1 month. Primary patency is defined as a target lesion without a hemodynamically significant stenosis/reocclusion on duplex ultrasound (\>50%,) and without target lesion reintervention (TLR) within 1 month.
Time frame: 1 month
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