The Protrieve PROTECTOR Study

Not Applicable

Recruiting

• Conditions: Deep Venous Thrombosis; Venous Thromboembolism
• Interventions: Device: Percutaneous mechanical thrombectomy (PMT)

• Registration Number: NCT06495996
• Lead Sponsor: Inari Medical

Brief Summary

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

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 Timeline

• Study First Submitted: 2024-07-03
• Study First Submitted QC: 2024-07-10
• Study First Posted: 2024-07-11
• Study Start: 2025-03-05
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-06
• Primary Completion: 2026-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 Subject has previously completed or withdrawn from this study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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Protrieve Sheath	Percutaneous mechanical thrombectomy (PMT)	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.

Primary Outcome Measures

Name	Time	Method
Primary Effectiveness Measure:	24 Hours (+-12 Hours)	a. Clinically significant PE
Primary Safety Measure:	24 Hours (+-12 Hours)	1. Protrieve device-related Major Adverse Events (MAEs); 2. Major Protrieve access site complications

Secondary Outcome Measures

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

Trial Locations

Locations (10)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

University of Texas Medical Branch; 🇺🇸 Galveston, Texas, United States

West Virginia University Hospital; 🇺🇸 Morgantown, West Virginia, United States

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

Englewood Hospital; 🇺🇸 Englewood, New Jersey, United States

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States