Evaluating the Protrieve Sheath for preventing pulmonary embolism during DVT treatment

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

This study is testing whether the Protrieve Sheath can help prevent serious lung clots during treatment for deep vein thrombosis in patients at higher risk.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Inari Medical (Industry-sponsored)
• Locations: 10 sites (Newport Beach, California and 9 other locations)
• Trial ID: NCT06495996 on ClinicalTrials.gov

What this trial studies

The Protrieve PROTECTOR Study is a prospective, single-arm, multicenter evaluation of the Protrieve Sheath, designed to assess its safety and effectiveness in preventing significant intraprocedural pulmonary embolism during thrombectomy procedures for deep venous thrombosis (DVT). The study focuses on patients at elevated risk for pulmonary embolism, particularly those with specific DVT characteristics. Participants will undergo percutaneous mechanical thrombectomy while using the Protrieve Sheath for embolic protection in the inferior vena cava (IVC).

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with planned interventions for DVT that present elevated risks for pulmonary embolism.

Not a fit: Patients currently experiencing symptomatic pulmonary embolism or with certain anatomical limitations will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly reduce the risk of pulmonary embolism during DVT treatment, improving patient safety and outcomes.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in using embolic protection devices during thrombectomy procedures.

Eligibility criteria

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

Where this trial is running

Newport Beach, California and 9 other locations

• Hoag Hospital — Newport Beach, California, United States (Recruiting)
• Yale University — New Haven, Connecticut, United States (Recruiting)
• Baptist Health South Florida — Miami, Florida, United States (Recruiting)
• IU Health Methodist Hospital — Indianapolis, Indiana, United States (Recruiting)
• MedStar Union Memorial Hospital — Baltimore, Maryland, United States (Recruiting)
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)
• Englewood Hospital — Englewood, New Jersey, United States (Recruiting)
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
• University of Texas Medical Branch — Galveston, Texas, United States (Recruiting)
• West Virginia University Hospital — Morgantown, West Virginia, United States (Recruiting)

Study contacts

• Principal investigator: Sabah D Butty, MD — Indiana University Health Methodist Hospital
• Study coordinator: Scott Skorupa

Conditions Venous Thromboembolism; Deep Venous Thrombosis; Percutaneous Mechanical Thrombectomy