NCT06495996

The Protrieve PROTECTOR Study

PROTECTOR: Evaluating the Safety and Effectiveness of the Protrieve Sheath in Preventing Clinically Significant Intraprocedural Pulmonary Embolism by Providing Embolic Protection in the IVC During Thrombectomy Procedures to Treat DVT

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Inari Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The Protrieve PROTECTOR Study is a prospective, single-arm, multicenter study of the Protrieve Sheath.

Detailed description

The primary study objective is to evaluate the safety and effectiveness of the Protrieve Sheath in preventing clinically significant intraprocedural pulmonary embolism by providing embolic protection in the IVC during thrombectomy procedures to treat DVT.

Conditions

• Venous Thromboembolism
• Deep Venous Thrombosis

Interventions

Type	Name	Description
DEVICE	Percutaneous mechanical thrombectomy (PMT)	Percutaneous mechanical thrombectomy (PMT) is the endovascular removal of thrombus by catheter-based mechanical or aspiration methods. The term PMT generally describes interventional procedures performed without the use of lytic agents and frequently involves instrumentation in extensive amounts of fresh thrombus.

Timeline

• Start date: 2025-03-05
• Primary completion: 2025-11-06
• Completion: 2025-11-06
• First posted: 2024-07-11
• Last updated: 2026-03-04

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated device study