The Protrieve PROTECTOR Study

NCT ID: NCT06495996

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-05
• Study Completion Date: 2025-11-06

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Protrieve Sheath

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.

Group Type: EXPERIMENTAL

Percutaneous mechanical thrombectomy (PMT)

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18 years

2. Planned intervention for DVT presenting with one or more of the following characteristics indicative of elevated risk for PE:

1. Bilateral iliofemoral DVT

2. Clot extending into or located in the IVC

3. In-stent thrombosis

4. Presence of thrombosed IVC filter

5. Other features that the investigator deems put the subject at elevated risk for thromboembolism

3. Willing and able to provide informed consent

Exclusion Criteria

1. Current symptomatic PE

2. Known anatomic inability to place Protrieve device via jugular vein access site

3. Presence of clot extending to the IVC-Right Atrial junction or in the SVC

4. Subject is pregnant

5. Severe allergy to iodinated contrast agents that cannot be mitigated

6. 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

7. 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

8. Subject is participating in another study that may interfere with this study

9. Subject has any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the subject

10. Subject has previously completed or withdrawn from this study

11. Limb-threatening circulatory compromise (e.g., phlegmasia)

12. Uncontrolled severe hypertension on repeated readings (systolic > 180mmHg or diastolic > 105mmHg)

13. Severe allergy, hypersensitivity to, or thrombocytopenia from heparin

14. Inability to provide therapeutic anticoagulation per Investigator discretion

15. Known hypercoagulable states that, in the opinion of the Investigator, cannot be medically managed throughout the study period

16. Inability to be a candidate for intervention due to medical or technical reasons based on physician judgement

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Inari Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sabah D Butty, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University Health Methodist Hospital

Locations

Hoag Hospital

Newport Beach, California, United States

Yale University

New Haven, Connecticut, United States

Baptist Health South Florida

Miami, Florida, United States

IU Health Methodist Hospital

Indianapolis, Indiana, United States

MedStar Union Memorial Hospital

Baltimore, Maryland, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

University Medical Center Southern Nevada

Las Vegas, Nevada, United States

Englewood Hospital

Englewood, New Jersey, United States

NYU Langone Medical Center

New York, New York, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

University of Texas Medical Branch

Galveston, Texas, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

West Virginia University Hospital

Morgantown, West Virginia, United States

Countries

United States

Other Identifiers

23-003

Identifier Type: -

Identifier Source: org_study_id