Post Market Surveillance to Evaluate the Efficacy and Safety of the INDIGO Aspiration System in Japan
- Conditions
- Arterial Occlusion Mesenteric Artery SuperiorAcute Limb IschemiaAcute DVT of Lower Extremity
- Interventions
- Device: Mechanical aspiration thrombectomy
- Registration Number
- NCT06446024
- Lead Sponsor
- Penumbra Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 500
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.
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 1: Indigo Aspiration System treatment Mechanical aspiration thrombectomy Mechanical aspiration thrombectomy
- Primary Outcome Measures
Name Time Method 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.
All Disease States: Device-related Serious adverse effects (SAE) and mortality 6 months post-treatment Device related SAE and all-cause mortality
SMA: Technical success Intraoperative Restoration of antegrade blood flow without the need for other revascularization procedures such as vascular surgery or bypass.
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
ALI: Major device-related bleeding in ALI patients Periprocedural Major bleeding events as defined by ISTH
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: 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Nara City Hospital
🇯🇵Nara, Japan