Deep Venous Thrombosis, Venous Thromboembolism
Conditions
Keywords
Venous Thromboembolism, Deep Venous Thrombosis, Percutaneous Mechanical Thrombectomy
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.
Interventions
DEVICEPercutaneous mechanical thrombectomy (PMT)
Percutaneous mechanical thrombectomy (PMT) is the endovascular removal of thrombus by catheter-based mechanical or aspiration methods. The term PMT generally describes interventional procedures performed without the use of lytic agents and frequently involves instrumentation in extensive amounts of fresh thrombus.
Sponsors
Inari Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 Subject has previously completed or withdrawn from this study 11.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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Blood Transfusions | 24 Hours (+-12 Hours) | e. Blood transfusions associated with Protrieve Sheath access site bleeding |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRipal Gandhi, MD
Baptist Hospital
Outcome results
None listed