The Protrieve PROTECTOR Study is a prospective, single-arm, multicenter study of the Protrieve Sheath.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
66
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.
Hoag Hospital
Newport Beach, California, United States
Yale University
New Haven, Connecticut, United States
Primary Effectiveness Measure:
a. Clinically significant PE
Time frame: 24 Hours (+-12 Hours)
Primary Safety Measure:
1. Protrieve device-related Major Adverse Events (MAEs) 2. Major Protrieve access site complications
Time frame: 24 Hours (+-12 Hours)
Capture of Thromboembolic Material
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
Time frame: 24 Hours (+-12 Hours)
Device Success
b. Device success, defined as successful delivery, deployment, and retrieval of the Protrieve device without complications
Time frame: 24 Hours (+-12 Hours)
Venous Access Routes
c. Thrombectomy via supplementary venous access routes
Time frame: 24 Hours (+-12 Hours)
Estimated Percentage of the Protrieve Funnel Obstructed
d. Estimated percentage of the Protrieve funnel obstructed by clot, as observed by visual inspection or imaging
Time frame: 24 Hours (+-12 Hours)
Blood Transfusions
e. Blood transfusions associated with Protrieve Sheath access site bleeding
Time frame: 24 Hours (+-12 Hours)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Baptist Health South Florida
Miami, Florida, United States
IU Health Methodist Hospital
Indianapolis, Indiana, United States
MedStar Union Memorial Hospital
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University Medical Center Southern Nevada
Las Vegas, Nevada, United States
Englewood Hospital
Englewood, New Jersey, United States
NYU Langone Medical Center
New York, New York, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
...and 5 more locations