The Protrieve PROTECTOR Study

Last updated: April 7, 2025
Sponsor: Inari Medical
Overall Status: Active - Recruiting

Phase

N/A

Condition

Thrombosis

Venous Thromboembolism

Thromboembolism

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 Subject has previously completed or withdrawn from this study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: 60
Treatment Group(s): 1
Primary Treatment: Percutaneous mechanical thrombectomy (PMT)
Phase:
Study Start date:
March 05, 2025
Estimated Completion Date:
March 31, 2026

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

    Active - Recruiting

  • Yale New Haven Hospital

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

  • Yale University

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

  • Baptist Health South Florida

    Miami, Florida 33176
    United States

    Active - Recruiting

  • IU Health Methodist Hospital

    Indianapolis, Indiana 46204
    United States

    Active - Recruiting

  • MedStar Union Memorial Hospital

    Baltimore, Maryland 21218
    United States

    Active - Recruiting

  • Englewood Hospital

    Englewood, New Jersey 07631
    United States

    Active - Recruiting

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.