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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Indigo Aspiration System treatment | Mechanical aspiration thrombectomy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mechanical aspiration thrombectomy | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| ALI: Target Limb Salvage | Target lower extremity salvage rate at (defined as: freedom from major amputation at or proximal to the ankle) | 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. | Intraoperative |
| ALI: Major device-related bleeding in ALI patients | Major bleeding events as defined by ISTH | Periprocedural |
| SMA: Technical success | Restoration of antegrade blood flow without the need for other revascularization procedures such as vascular surgery or bypass. | 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. | Intraoperative |
| DVT: Technical success | Complete or near complete (75% or more) reduction in venous thrombosis, as assessed by visual evaluation of intraoperative venography |
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Inclusion Criteria:
Patients who meet Appropriate Use Criteria per local Japanese requirements for acute lower limb artery, acute upper mesentery artery occlusions, or severe acute deep vein thrombosis.
Exclusion Criteria:
Patients who do not meet Appropriate Use Criteria per local Japanese requirements for acute lower limb artery, acute upper mesentery artery occlusions, or severe acute deep vein thrombosis.
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The INDIGO System is intended for use in patients with acute lower limb artery occlusion, acute superior mesenteric artery occlusion, or severe acute deep vein thrombosis who require immediate treatment and for whom it is difficult to perform surgical thrombectomy or who are expected to have no effective therapeutic effect.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nara City Hospital | Nara | 630-8305 | Japan |
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| Intraoperative |
| DVT: Major Device-Related Bleeding | Major device-related bleeding as defined by ISTH | 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. | 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 | 30 days post-treatment |
| All Disease States: Device-related Serious adverse effects (SAE) and mortality | Device related SAE and all-cause mortality | 6 months post-treatment |