Protrieve PROTECTOR Study
S
Sabah D. Butty, MD
Primary Investigator
Enrolling By Invitation
18 years - 100 years
All
Phase
N/A
1 participants needed
1 Location
Brief description of study
What is the purpose of this study?
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.
THIS STUDY IS ENROLLING BY INVITATION ONLY
Detailed description of study
What will happen during the study?
- The study is a prospective, single-arm, multicenter Pivotal IDE study to evaluate the safety and effectiveness of the Protrieve Sheath in patients eligible for endovascular treatment of DVT.
- The enrollment period is expected to last approximately 18 months.
- Each study subject will actively participate for up to 24 hours (± 12 hours) or hospital discharge, whichever is sooner, following treatment.
- Study participation includes screening, baseline, index treatment, and the 24-hour visit.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Deep Venous Thrombosis, DVT, Venous Thromboembolism
-
Age: 18 years - 100 years
-
Gender: All
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Severe allergy to iodinated contrast agents that cannot be mitigated
- 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
- 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 is participating in another study that may interfere with this study
- Subject has any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the subject
- Subject has previously completed or withdrawn from this study
- Limb-threatening circulatory compromise (e.g., phlegmasia)
- Uncontrolled severe hypertension on repeated readings (systolic > 180mmHg or diastolic > 105mmHg)
- Severe allergy, hypersensitivity to, or thrombocytopenia from heparin
- 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
Updated on
22 Apr 2025.
Study ID: RADY-INARI-PROTECTOR, 24654
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