The Protrieve PROTECTOR Study (PROTECTOR)

August 7, 2026 updated by: Inari Medical

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
66

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • California
      • Newport Beach, California, United States, 92663
        • Hoag Hospital
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale University
    • Florida
      • Miami, Florida, United States, 33176
        • Baptist Health South Florida
    • Indiana
      • Indianapolis, Indiana, United States, 46204
        • IU Health Methodist Hospital
    • Maryland
      • Baltimore, Maryland, United States, 21218
        • MedStar Union Memorial Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • University Medical Center Southern Nevada
    • New Jersey
      • Englewood, New Jersey, United States, 07631
        • Englewood Hospital
    • New York
      • New York, New York, United States, 10016
        • NYU Langone Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General Hospital
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Vanderbilt University Medical Center
    • Texas
      • Galveston, Texas, United States, 77555
        • University of Texas Medical Branch
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Primary Effectiveness Measure:
Time Frame: 24 Hours (+-12 Hours)
a. Clinically significant PE
24 Hours (+-12 Hours)
Primary Safety Measure:
Time Frame: 24 Hours (+-12 Hours)
  1. Protrieve device-related Major Adverse Events (MAEs)
  2. Major Protrieve access site complications
24 Hours (+-12 Hours)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Capture of Thromboembolic Material
Time Frame: 24 Hours (+-12 Hours)
a. Capture and removal of thromboembolic material in the Protrieve funnel, as assessed by proportion of study cases where any material was either entrapped in the funnel or removed via Protrieve
24 Hours (+-12 Hours)
Device Success
Time Frame: 24 Hours (+-12 Hours)
b. Device success, defined as successful delivery, deployment, and retrieval of the Protrieve device without complications
24 Hours (+-12 Hours)
Venous Access Routes
Time Frame: 24 Hours (+-12 Hours)
c. Thrombectomy via supplementary venous access routes
24 Hours (+-12 Hours)
Estimated Percentage of the Protrieve Funnel Obstructed
Time Frame: 24 Hours (+-12 Hours)
d. Estimated percentage of the Protrieve funnel obstructed by clot, as observed by visual inspection or imaging
24 Hours (+-12 Hours)
Blood Transfusions
Time Frame: 24 Hours (+-12 Hours)
e. Blood transfusions associated with Protrieve Sheath access site bleeding
24 Hours (+-12 Hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Inari Medical

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ripal Gandhi, MD, Baptist Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 5, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 6, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 6, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 3, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 11, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 23-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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