NCT07280247

Acute Pulmonary Embolism Treatment With the AlphaVac Multipurpose Mechanical Aspiration System and the AlphaReturn Blood Management System: Evaluation of Safety and Effectiveness

Acute Pulmonary Embolism Treatment With the AlphaVac Multipurpose Mechanical Aspiration System and the AlphaReturn Blood Management System: Evaluation of Safety and Effectiveness (APEX-Return)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 39 (estimated)
• Sponsor: Angiodynamics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigation is intended to evaluate the safety and effectiveness of the AlphaReturn Blood Management System when used in conjunction with the cleared AlphaVac MMA F1885 System for the treatment of acute pulmonary embolism.

Detailed description

This is a prospective, multicenter, single-arm investigational device study evaluating safety and effectiveness.

Conditions

• Pulmonary Embolism Acute

Interventions

Type	Name	Description
DEVICE	AlphaReturn Blood Management System	The AlphaReturn Blood Management System allows for autologous injection of aspirated blood from an AlphaVac MMA System thrombectomy procedure.

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2025-12-12
• Last updated: 2026-03-06

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study