The Protrieve PROTECTOR Study

Last updated: December 1, 2025
Sponsor: Inari Medical
Overall Status: Completed

Phase

N/A

Condition

Venous Thrombosis

Claudication

Vascular Diseases

Treatment

Percutaneous mechanical thrombectomy (PMT)

Clinical Study ID

NCT06495996
23-003
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥ 18 years

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

  3. Bilateral iliofemoral DVT

  4. Clot extending into or located in the IVC

  5. In-stent thrombosis

  6. Presence of thrombosed IVC filter

  7. Other features that the investigator deems put the subject at elevated risk forthromboembolism

  8. Willing and able to provide informed consent

Exclusion

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 whichcannot 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 theInvestigator's discretion would pose risk to the patient with the use of marketedcontrast 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 Subject has previously completed or withdrawn from this study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 ordiastolic > 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 bemedically managed throughout the study period

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

Study Design

Total Participants: 66
Treatment Group(s): 1
Primary Treatment: Percutaneous mechanical thrombectomy (PMT)
Phase:
Study Start date:
March 05, 2025
Estimated Completion Date:
November 06, 2025

Study 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.

Connect with a study center

  • Hoag Hospital

    Newport Beach, California 92663
    United States

    Site Not Available

  • Hoag Hospital

    Newport Beach 5376890, California 5332921 92663
    United States

    Site Not Available

  • Yale New Haven Hospital

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

  • Yale University

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Yale University

    New Haven 4839366, Connecticut 4831725 06510
    United States

    Site Not Available

  • Baptist Health South Florida

    Miami, Florida 33176
    United States

    Site Not Available

  • Baptist Health South Florida

    Miami 4164138, Florida 4155751 33176
    United States

    Site Not Available

  • IU Health Methodist Hospital

    Indianapolis, Indiana 46204
    United States

    Site Not Available

  • IU Health Methodist Hospital

    Indianapolis 4259418, Indiana 4921868 46204
    United States

    Site Not Available

  • MedStar Union Memorial Hospital

    Baltimore, Maryland 21218
    United States

    Site Not Available

  • MedStar Union Memorial Hospital

    Baltimore 4347778, Maryland 4361885 21218
    United States

    Site Not Available

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Beth Israel Deaconess Medical Center

    Boston 4930956, Massachusetts 6254926 02215
    United States

    Site Not Available

  • University Medical Center Las Vegas

    Las Vegas, Nevada 89102
    United States

    Site Not Available

  • University Medical Center Las Vegas

    Las Vegas 5506956, Nevada 5509151 89102
    United States

    Site Not Available

  • University Medical Center Southern Nevada

    Las Vegas 5506956, Nevada 5509151 89102
    United States

    Site Not Available

  • Englewood Hospital

    Englewood, New Jersey 07631
    United States

    Site Not Available

  • Englewood Hospital

    Englewood 5097672, New Jersey 5101760 07631
    United States

    Site Not Available

  • NYU Langone Medical Center

    New York, New York 10016
    United States

    Site Not Available

  • NYU Langone Medical Center

    New York 5128581, New York 5128638 10016
    United States

    Site Not Available

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania 15212
    United States

    Site Not Available

  • Hospital of the University of Pennsylvania

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Site Not Available

  • Allegheny General Hospital

    Pittsburgh 5206379, Pennsylvania 6254927 15212
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Site Not Available

  • University of Texas Medical Branch

    Galveston, Texas 77555
    United States

    Site Not Available

  • University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Texas Medical Branch

    Galveston 4692883, Texas 4736286 77555
    United States

    Site Not Available

  • University of Texas MD Anderson Cancer Center

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • West Virginia University Hospital

    Morgantown, West Virginia 26506
    United States

    Site Not Available

  • West Virginia University Hospital

    Morgantown 4815352, West Virginia 4826850 26506
    United States

    Site Not Available

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