Post Market Surveillance to Evaluate the Efficacy and Safety of the INDIGO Aspiration System in Japan

NCT06446024 | Completed FDA Device

• 1 other identifier: 27548
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Limb Ischemia; Arterial Occlusion Mesenteric Artery Superior; Acute DVT of Lower Extremity

Outcome Measures

Primary Outcomes (10)

• 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

  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

Study Arms (1)

Group 1: Indigo Aspiration System treatment

Mechanical aspiration thrombectomy

Device: Mechanical aspiration thrombectomy

Interventions

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.

Group 1: Indigo Aspiration System treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Penumbra Inc.: lead

Study Sites (1)

Nara City Hospital

Nara, 630-8305, Japan

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: June 6, 2024
• Study Start: December 7, 2023
• Primary Completion: July 25, 2025
• Study Completion: July 25, 2025
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)