The Protrieve PROTECTOR Study

Ki vehet részt

• Age ≥ 18 years
• Planned intervention for DVT presenting with one or more of the following characteristics indicative of elevated risk for PE:; Bilateral iliofemoral DVT; Clot extending into or located in the IVC; In-stent thrombosis; Presence of thrombosed IVC filter; Other features that the investigator deems put the subject at elevated risk for thromboembolism
• Willing and able to provide informed consent

Ki nem vehet részt

• Subject has previously completed or withdrawn from this study
• Severe allergy to iodinated contrast agents that cannot be mitigated
• 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
• Subject has any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the subject
• Uncontrolled severe hypertension on repeated readings (systolic > 180mmHg or diastolic > 105mmHg)
• Severe allergy, hypersensitivity to, or thrombocytopenia from heparin
• 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
• Current symptomatic PE
• Known anatomic inability to place Protrieve device via jugular vein access site
• Presence of clot extending to the IVC-Right Atrial junction or in the SVC
• Subject is pregnant
• Subject is participating in another study that may interfere with this study
• Limb-threatening circulatory compromise (e.g., phlegmasia)
• Inability to provide therapeutic anticoagulation per Investigator discretion
• Known hypercoagulable states that, in the opinion of the Investigator, cannot be medically managed throughout the study period
• Inability to be a candidate for intervention due to medical or technical reasons based on physician judgement