Acute DVT of Lower Extremity, Acute Limb Ischemia, Arterial Occlusion Mesenteric Artery Superior
Conditions
Brief summary
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.
Interventions
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.
Sponsors
Penumbra Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ALI: Target Limb Salvage | 30 days post-treatment and 6 months post-treatment | Target lower extremity salvage rate at (defined as: freedom from major amputation at or proximal to the ankle) |
| ALI: Technical Success | Intraoperative | 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. |
| ALI: Major device-related bleeding in ALI patients | Periprocedural | Major bleeding events as defined by ISTH |
| SMA: Technical success | Intraoperative | Restoration of antegrade blood flow without the need for other revascularization procedures such as vascular surgery or bypass. |
| SMA: Device-related Distal Embolization | Intraoperative | 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. |
| DVT: Technical success | Intraoperative | Complete or near complete (75% or more) reduction in venous thrombosis, as assessed by visual evaluation of intraoperative venography |
| DVT: Major Device-Related Bleeding | Periprocedural | Major device-related bleeding as defined by ISTH |
| DVT: New Symptomatic Pulmonary Embolism (PE) | 30 days post-treatment | Symptomatic new PE objectively confirmed on Computed Tomographic Pulmonary Angiography (CTPA), echocardiography, MRI, or invasive contrast pulmonary angiography. |
| DVT: Clinically significant re-thrombosis of the target venous segment | 30 days post-treatment | Re-thrombosis of target vein segment requiring re-intervention within 30 days |
| All Disease States: Device-related Serious adverse effects (SAE) and mortality | 6 months post-treatment | Device related SAE and all-cause mortality |
Countries
Japan
Outcome results
None listed