COMPLETED

The Protrieve PROTECTOR Study

Conditions

Venous Thromboembolism Deep Venous Thrombosis Percutaneous Mechanical Thrombectomy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official 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

Quick Facts

Study Start:2025-03-05

Study Completion:2025-11-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06495996

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Principal Investigator

Sabah D Butty, MD

PRINCIPAL_INVESTIGATOR

Indiana University Health Methodist Hospital

Study Locations (Sites)

Hoag Hospital

Newport Beach, California, 92663

United States

Yale University

New Haven, Connecticut, 06510

United States

Baptist Health South Florida

Miami, Florida, 33176

United States

IU Health Methodist Hospital

Indianapolis, Indiana, 46204

United States

MedStar Union Memorial Hospital

Baltimore, Maryland, 21218

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

United States

University Medical Center Southern Nevada

Las Vegas, Nevada, 89102

United States

Englewood Hospital

Englewood, New Jersey, 07631

United States

NYU Langone Medical Center

New York, New York, 10016

United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212

United States

Vanderbilt University Medical Center

Nashville, Tennessee, 37203

United States

University of Texas Medical Branch

Galveston, Texas, 77555

United States

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030

United States

West Virginia University Hospital

Morgantown, West Virginia, 26506

United States

Collaborators and Investigators

Sponsor: Inari Medical

Sabah D Butty, MD, PRINCIPAL_INVESTIGATOR, Indiana University Health Methodist Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-05

Study Completion Date2025-11-06

Study Record Updates

Study Start Date2025-03-05

Study Completion Date2025-11-06

Terms related to this study

Keywords Provided by Researchers

Venous Thromboembolism
Deep Venous Thrombosis
Percutaneous Mechanical Thrombectomy

Additional Relevant MeSH Terms

Venous Thromboembolism
Deep Venous Thrombosis