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Completed

NCT Number: NCT06495996

The Protrieve PROTECTOR Study

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

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Key information

Conditions

Venous Thromboembolism Cardiovascular Diseases Deep Venous Thrombosis Embolism and Thrombosis Thromboembolism Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hoag Hospital, Newport Beach, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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  • Subject has previously completed or withdrawn from this study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

Treatment and study plan

Percutaneous mechanical thrombectomy (PMT)

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.

Primary outcomes

  1. Primary Effectiveness Measure:

    Time frame: 24 Hours (+-12 Hours)

    a. Clinically significant PE

  2. Primary Safety Measure:

    Time frame: 24 Hours (+-12 Hours)

    • Protrieve device-related Major Adverse Events (MAEs)
    • Major Protrieve access site complications

Secondary outcomes

  1. 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

  2. Device Success

    Time frame: 24 Hours (+-12 Hours)

    b. Device success, defined as successful delivery, deployment, and retrieval of the Protrieve device without complications

  3. Venous Access Routes

    Time frame: 24 Hours (+-12 Hours)

    c. Thrombectomy via supplementary venous access routes

  4. 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

  5. Blood Transfusions

    Time frame: 24 Hours (+-12 Hours)

    e. Blood transfusions associated with Protrieve Sheath access site bleeding

Sponsors and collaborators

Lead sponsor

Inari Medical

Industry

Registry information

Official study title

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

Acronym: PROTECTOR

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 11, 2024
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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