This study aims to confirm the safety and effectiveness of the INDIGO Aspiration System in patients requiring immediate treatment for acute lower extremity artery occlusion, acute superior mesenteric artery occlusion, or severe acute deep vein thrombosis. Primary objective of the study is to collect predetermined data on use, safety and effectiveness, including clinical and technical performance of the INDIGO System in Japan.
Study Type
OBSERVATIONAL
Enrollment
500
Mechanical thrombectomy is an endovascular technique for removing blood clots from vessels. Penumbra's Indigo system actively extracts thrombus using a continuous vacuum pump, enabling aspiration of thrombus of various sizes and lengths.
Nara City Hospital
Nara, Japan
ALI: Target Limb Salvage
Target lower extremity salvage rate at (defined as: freedom from major amputation at or proximal to the ankle)
Time frame: 30 days post-treatment and 6 months post-treatment
ALI: Technical Success
Primary technical success should be defined per vessel treated on an intent-to-treat basis and applies only to segment treated with Indigo. Defined as successful use of the device to re-establish any antegrade flow and complete or near complete (95% by volume) removal of thrombus as assessed by visual analysis of angiographic images or by other objective imaging such as DUS, CTA, or MRA.
Time frame: Intraoperative
ALI: Major device-related bleeding in ALI patients
Major bleeding events as defined by ISTH
Time frame: Periprocedural
SMA: Technical success
Restoration of antegrade blood flow without the need for other revascularization procedures such as vascular surgery or bypass.
Time frame: Intraoperative
SMA: Device-related Distal Embolization
A distal filling defect with an abrupt cut-off, determined to be new since the pre-procedure angiogram, present at the end of the procedure, and clinically significant requiring intervention other than Indigo use. If the area in question was not clearly visualized, filling defects distal to the target lesion cannot be categorized as emboli.
Time frame: Intraoperative
DVT: Technical success
Complete or near complete (75% or more) reduction in venous thrombosis, as assessed by visual evaluation of intraoperative venography
Time frame: Intraoperative
DVT: Major Device-Related Bleeding
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Major device-related bleeding as defined by ISTH
Time frame: Periprocedural
DVT: New Symptomatic Pulmonary Embolism (PE)
Symptomatic new PE objectively confirmed on Computed Tomographic Pulmonary Angiography (CTPA), echocardiography, MRI, or invasive contrast pulmonary angiography.
Time frame: 30 days post-treatment
DVT: Clinically significant re-thrombosis of the target venous segment
Re-thrombosis of target vein segment requiring re-intervention within 30 days
Time frame: 30 days post-treatment
All Disease States: Device-related Serious adverse effects (SAE) and mortality
Device related SAE and all-cause mortality
Time frame: 6 months post-treatment