The Protrieve PROTECTOR Study (PROTECTOR)

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: Completed
• Conditions: Venous Thromboembolism; Deep Venous Thrombosis
• Intervention / Treatment: Device: Percutaneous mechanical thrombectomy (PMT)

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: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Primary Effectiveness Measure:	a. Clinically significant PE	24 Hours (+-12 Hours)
Primary Safety Measure:	Protrieve device-related Major Adverse Events (MAEs); Major Protrieve access site complications	24 Hours (+-12 Hours)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Capture of Thromboembolic Material	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	b. Device success, defined as successful delivery, deployment, and retrieval of the Protrieve device without complications	24 Hours (+-12 Hours)
Venous Access Routes	c. Thrombectomy via supplementary venous access routes	24 Hours (+-12 Hours)
Estimated Percentage of the Protrieve Funnel Obstructed	d. Estimated percentage of the Protrieve funnel obstructed by clot, as observed by visual inspection or imaging	24 Hours (+-12 Hours)
Blood Transfusions	e. Blood transfusions associated with Protrieve Sheath access site bleeding	24 Hours (+-12 Hours)

Collaborators and Investigators

• Sponsor: Inari Medical
• Investigators: Principal Investigator: Sabah D Butty, MD, Indiana University Health Methodist Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2025
• Primary Completion (Actual): November 6, 2025
• Study Completion (Actual): November 6, 2025

Study Registration Dates

• First Submitted: July 3, 2024
• First Submitted That Met QC Criteria: July 10, 2024
• First Posted (Actual): July 11, 2024

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Venous Thromboembolism; Deep Venous Thrombosis; Percutaneous Mechanical Thrombectomy
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Embolism and Thrombosis; Thromboembolism; Thrombosis; Venous Thrombosis; Venous Thromboembolism
• Other Study ID 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