The Protrieve PROTECTOR Study

Launched by INARI MEDICAL · Jul 10, 2024

Keywords

ClinConnect Summary

The Protrieve PROTECTOR Study is a clinical trial that is examining a device called the Protrieve Sheath, which is used to help treat a condition known as deep venous thrombosis (DVT). DVT occurs when a blood clot forms in the deep veins, usually in the legs, and can lead to more serious problems like a pulmonary embolism (PE), where a clot travels to the lungs. This study is currently looking for participants who are 18 years or older and have specific risk factors that could increase their chances of developing a PE, such as having multiple clots or certain types of existing clots.

Participants in this study will receive the Protrieve Sheath as part of their treatment plan. To join, individuals must be willing to provide consent and meet certain health criteria, while those with specific conditions, such as a current PE or severe allergies to certain contrast agents, will not be eligible. The study is being conducted at multiple centers, and while it is still recruiting participants, it aims to gather important information about how effectively the Protrieve Sheath can help manage DVT and reduce the risk of complications.

Gender

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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