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.
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ALI: Target Limb Salvage
Timeframe: 30 days post-treatment and 6 months post-treatment
ALI: Technical Success
Timeframe: Intraoperative
ALI: Major device-related bleeding in ALI patients
Timeframe: Periprocedural
SMA: Technical success
Timeframe: Intraoperative
SMA: Device-related Distal Embolization
Timeframe: Intraoperative
DVT: Technical success
Timeframe: Intraoperative
DVT: Major Device-Related Bleeding
Timeframe: Periprocedural
DVT: New Symptomatic Pulmonary Embolism (PE)
Timeframe: 30 days post-treatment
DVT: Clinically significant re-thrombosis of the target venous segment
Timeframe: 30 days post-treatment
All Disease States: Device-related Serious adverse effects (SAE) and mortality
Timeframe: 6 months post-treatment