The Protrieve PROTECTOR Study

Inari Medical

Status: Begins enrollment this month

Conditions: Venous Thromboembolism; Deep Venous Thrombosis

Treatments: Device: Percutaneous mechanical thrombectomy (PMT)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06495996

23-003

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 Subject has previously completed or withdrawn from this study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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Protrieve Sheath

Experimental group

Description:

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.

Treatment:

Device: Percutaneous mechanical thrombectomy (PMT)