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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment by "Indigo" mechanical thrombectomy system | Other | Acute or Chronic clot: if chronic (> 14 days) no intervention given via Indigo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "Indigo" Mechanical Thrombectomy System | Device | Removal of acute clot (< 14 days) from the artery causing lower limb ischemia, using the "Indigo" System by Penumbra |
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| Measure | Description | Time Frame |
|---|---|---|
| Technical 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. | At intra-procedural completion angiography |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 month |
| Safety Rate at discharge: Serious adverse event. |
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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
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gianmarco de Donato, MD | Contact | +390577585123 | dedonato@unisi.it | |
| Carlo Setacci, MD | Contact | +390577233443 | setacci@unisi.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vascular Surgery, University of Siena | Recruiting | Siena | 53100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25644826 | Background | 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. |
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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. |
| 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. | 1 month |