The Protrieve PROTECTOR Study

NCT06495996 | Completed FDA Device

• 1 other identifier: 23-003
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 15

Brief Summary

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

Conditions

Venous Thromboembolism; Deep Venous Thrombosis

Keywords

Venous Thromboembolism; Deep Venous Thrombosis; Percutaneous Mechanical Thrombectomy

Outcome Measures

Primary Outcomes (2)

• Primary Effectiveness Measure:

  a. Clinically significant PE

  24 Hours (+-12 Hours)

• Primary Safety Measure:

  1. Protrieve device-related Major Adverse Events (MAEs) 2. Major Protrieve access site complications

  24 Hours (+-12 Hours)

Secondary Outcomes (5)

• Capture of Thromboembolic Material

  24 Hours (+-12 Hours)

• Device Success

  24 Hours (+-12 Hours)

• Venous Access Routes

  24 Hours (+-12 Hours)

• Estimated Percentage of the Protrieve Funnel Obstructed

  24 Hours (+-12 Hours)

• Blood Transfusions

  24 Hours (+-12 Hours)

Study Arms (1)

Protrieve Sheath

EXPERIMENTAL

The Protrieve Sheath is intended for embolic protection in the inferior vena cava (IVC) to prevent clinically significant intraprocedural pulmonary embolism during mechanical thrombectomy procedures in patients with high risk of embolization.

Device: Percutaneous mechanical thrombectomy (PMT)

Interventions

Percutaneous mechanical thrombectomy (PMT) DEVICE

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.

Protrieve Sheath

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Planned intervention for DVT presenting with one or more of the following characteristics indicative of elevated risk for PE:
• Bilateral iliofemoral DVT
• Clot extending into or located in the IVC
• In-stent thrombosis
• Presence of thrombosed IVC filter
• Other features that the investigator deems put the subject at elevated risk for thromboembolism
• Willing and able to provide informed consent

You may not qualify if:

• Current symptomatic PE
• Known anatomic inability to place Protrieve device via jugular vein access site
• Presence of clot extending to the IVC-Right Atrial junction or in the SVC
• Subject is pregnant
• Severe allergy to iodinated contrast agents that cannot be mitigated
• INR \> 1.7 if not currently on anticoagulation therapy, platelets \< 50,000/μl which cannot be corrected prior to enrollment, or Hemoglobin \< 8.0 g/dL
• Severe renal impairment in patients who are not yet on dialysis that in the Investigator's discretion would pose risk to the patient with the use of marketed contrast agents
• Subject is participating in another study that may interfere with this study
• Subject has any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the subject
• Subject has previously completed or withdrawn from this study
• Limb-threatening circulatory compromise (e.g., phlegmasia)
• Uncontrolled severe hypertension on repeated readings (systolic \> 180mmHg or diastolic \> 105mmHg)
• Severe allergy, hypersensitivity to, or thrombocytopenia from heparin
• Inability to provide therapeutic anticoagulation per Investigator discretion
• Known hypercoagulable states that, in the opinion of the Investigator, cannot be medically managed throughout the study period

Sponsors & Collaborators

• Inari Medical: lead

Study Sites (15)

Hoag Hospital

Newport Beach, California, 92663, United States

Location

Yale University

New Haven, Connecticut, 06510, United States

Location

Baptist Health South Florida

Miami, Florida, 33176, United States

Location

IU Health Methodist Hospital

Indianapolis, Indiana, 46204, United States

Location

MedStar Union Memorial Hospital

Baltimore, Maryland, 21218, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University Medical Center Southern Nevada

Las Vegas, Nevada, 89102, United States

Location

Englewood Hospital

Englewood, New Jersey, 07631, United States

Location

NYU Langone Medical Center

New York, New York, 10016, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

West Virginia University Hospital

Morgantown, West Virginia, 26506, United States

Location

MeSH Terms

Conditions

Venous Thromboembolism; Venous Thrombosis

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thrombosis

Study Officials

• Sabah D Butty, MD

  Indiana University Health Methodist Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 11, 2024
• Study Start: March 5, 2025
• Primary Completion: November 6, 2025
• Study Completion: November 6, 2025
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)