PROTECTOR Study: IVC Embolic Protection with Protrieve Sheath During DVT Thrombectomy

The PROTECTOR clinical trial evaluates the safety and effectiveness of the Protrieve Sheath, an innovative device designed to prevent clinically significant pulmonary embolism (PE) during deep vein thrombosis (DVT) thrombectomy procedures. This interventional study focuses on high-risk patients with conditions such as bilateral iliofemoral DVT, IVC involvement, or thrombosed IVC filters that increase their susceptibility to thromboembolic complications.

Study Design: This single-arm, open-label trial will enroll approximately 60 adult participants at elevated risk for intraprocedural PE. The Protrieve Sheath serves as an embolic protection system in the inferior vena cava during percutaneous mechanical thrombectomy (PMT). Key objectives include:

• Primary effectiveness outcome: Prevention of clinically significant PE within 24 hours
• Primary safety outcome: Assessment of device-related major adverse events and access site complications

Patient Eligibility: Inclusion criteria require patients ≥18 years scheduled for DVT intervention with specific high-risk features. Exclusion criteria address conditions like existing symptomatic PE, anatomical constraints, pregnancy, coagulation disorders, and contrast allergies.

Secondary Outcomes: The study will also examine:

1. Capture rate of thromboembolic material in the Protrieve funnel
2. Device deployment and retrieval success
3. Need for supplementary venous access
4. Funnel obstruction percentages
5. Blood transfusion requirements

Conducted by Inari Medical with principal investigator Dr. Sabah D Butty at Indiana University Health Methodist Hospital, the PROTECTOR trial represents an important advancement in procedural safety for complex DVT cases. Enrollment is estimated to begin in March 2025, with primary completion targeted for March 2026.