NCT06571760

Selective Pulmonary-artery Intervention to Reduce Acute Right-heart tEnsion-I

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Neptune Medical · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

This study study is a prospective, single-arm, multicenter study to evaluate the safety and effectiveness of the Vertex Pulmonary Embolectomy System in participants presenting with clinical signs and symptoms of pulmonary embolism.

Detailed description

The study is a prospective, single-arm, multicenter study to evaluate the safety and effectiveness of the Vertex Pulmonary Embolectomy System in participants presenting with clinical signs and symptoms of acute pulmonary embolism. The Vertex Pulmonary Embolectomy System is intended for the non-surgical removal of emboli and thrombi from blood vessels as a means for treating pulmonary embolism.

Conditions

• Pulmonary Embolism

Interventions

Type	Name	Description
DEVICE	Vertex Pulmonary Embolectomy System	Use of Vertex Pulmonary Embolectomy System to treat pulmonary embolism.

Timeline

• Start date: 2024-09-10
• Primary completion: 2025-04-24
• Completion: 2025-05-21
• First posted: 2024-08-26
• Last updated: 2025-05-29

Locations

2 sites across 2 countries: Austria, Poland

Regulatory

• FDA-regulated device study