The Protrieve PROTECTOR Study

Completed · Not applicable

Conditions studied: Venous Thromboembolism, Deep Venous Thrombosis

In brief

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

Key facts

Study ID

NCT06495996

Run by

Inari Medical

People needed

66

Starts

2025-03-05

Expected to finish

2025-11-06

Last updated by the study team

2026-07-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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• Subject has previously completed or withdrawn from this study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
• Inability to be a candidate for intervention due to medical or technical reasons based on physician judgement

Where it is running

• 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

Full record on ClinicalTrials.gov

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