NCT05318092

Evaluating the Safety and Efficacy of the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE for Treatment of Acute Pulmonary Embolism

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: Angiodynamics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and effectiveness of percutaneous mechanical aspiration thrombectomy using the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE in a prospective trial of patients with acute intermediate-risk pulmonary embolism (PE).

Conditions

• Pulmonary Embolism
• Acute Pulmonary Embolism

Interventions

Type	Name	Description
DEVICE	AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE	The AngioDynamics' AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE has five main components, a flexible cannula (F1885), sheath, tapered obturator, aspirator handle, and waste bag.

Timeline

• Start date: 2022-10-19
• Primary completion: 2024-01-04
• Completion: 2024-01-04
• First posted: 2022-04-08
• Last updated: 2024-07-19
• Results posted: 2024-07-19

Locations

25 sites across 1 country: United States

Regulatory

• FDA-regulated device study