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

Penumbra

Status: Completed

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

Treatments: Device: Mechanical aspiration thrombectomy

Study type: Observational

Funder types: Industry

Identifiers

NCT06446024

27548

Details and patient eligibility

About

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.

Enrollment: 500 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

500 participants in 1 patient group

Group 1: Indigo Aspiration System treatment

Description:

Mechanical aspiration thrombectomy

Treatment:

Device: Mechanical aspiration thrombectomy