NCT06362928

Safety and Effectiveness of the Akura Thrombectomy System in the Treatment of Acute Pulmonary Embolism

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Akura Medical · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, single-arm, non-randomized, interventional, multicenter feasibility study to evaluate the safety and effectiveness of percutaneous mechanical thrombectomy using the Akura Thrombectomy System in subjects with acute pulmonary embolism (PE).

Conditions

• Pulmonary Embolism Acute

Interventions

Type	Name	Description
DEVICE	ATC System	The ATC System is designed to mechanically remove emboli and restore blood flow through the pulmonary arteries in patients experiencing acute PE

Timeline

• Start date: 2025-02-15
• Primary completion: 2026-01-01
• Completion: 2026-02-01
• First posted: 2024-04-12
• Last updated: 2025-07-28

Locations

1 site across 1 country: Austria

Regulatory

• FDA-regulated device study