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

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.

Study Overview

• Status: Completed
• Conditions: Arterial Occlusion Mesenteric Artery Superior; Acute Limb Ischemia; Acute DVT of Lower Extremity
• Intervention / Treatment: Device: Mechanical aspiration thrombectomy

• Study Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• Japan
  • Nara, Japan, 630-8305
    • Nara City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1: Indigo Aspiration System treatment; Mechanical aspiration thrombectomy	Device: Mechanical aspiration thrombectomy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Penumbra Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2023
• Primary Completion (Actual): July 25, 2025
• Study Completion (Actual): July 25, 2025

Study Registration Dates

• First Submitted: May 13, 2024
• First Submitted That Met QC Criteria: June 4, 2024
• First Posted (Actual): June 6, 2024

Study Record Updates

• Last Update Posted (Actual): February 4, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Arterial Occlusive Diseases
• Other Study ID Numbers: 27548

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes