NCT06446024

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 500 (actual)
• Sponsor: Penumbra Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-12-07
• Primary completion: 2025-07-25
• Completion: 2025-07-25
• First posted: 2024-06-06
• Last updated: 2026-02-04

Locations

1 site across 1 country: Japan

Regulatory

• FDA-regulated device study