The RAPID - PE Study: RESCUE Advanced Protocol for the Treatment of Pulmonary Embolism
Start Date
10/17/2024
Completion Date
4/25/2028
Summary
To demonstrate the efficacy and safety of the 8F BASHIR™ .035 Endovascular Catheter and the 8F BASHIR™ S-B .035 Endovascular Catheter for the administration of pharmaco-mechanical catheter directed therapy using pulse sprays of r-tPA into the pulmonary arteries for the treatment of intermediate risk pulmonary embolism (PE).
Detailed Description
The BASHIR™ .035 Endovascular Catheter (BEC) and the BEC Short Basket .035 (S-B) are devices intended for the localized infusion of therapeutic agents into the pulmonary artery and peripheral vasculature. The distal infusion segment of the device contains an expandable radial array of conduits with a total of 48 laser drilled orifices used for the delivery of the therapeutic agents at multiple cross-sectional points of the target vessel location. The infusion segment can be expanded and collapsed by the actuator (slider) located on the handle at the proximal end of the device. The infusion line connector is also located on the handle. The difference between the BEC .035 and the BEC S-B.035 is solely in the length of the basket. In its unexpanded state, the basket of the BEC .035 is 12.5cm long and the BEC S-B .035 basket is 10cm long. The choice of device used will be at the physician's discretion based on the patient's anatomy.
Eligibility Criteria
Age Range: No minimum to No maximum
Interventions
The Bashir™ Endovascular Catheter
r-tPA
Conditions
Locations
Honor Health
Scottsdale, Arizona 85258
United States
Carondelet St. Joseph's Hospital
Tuscon, Arizona 85711
United States
Radiology and Imaging Specialists
Lakeland, Florida 33801
United States
Emory University
Atlanta, Georgia 30308
United States
Rush University Medical Center
Chicago, Illinois 60612
United States
Profound Research
Hobart, Indiana 46342
United States
Community Health
Indianapolis, Indiana 46256
United States
Boston Medical Center
Boston, Massachusetts 02135
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02481
United States
Lahey Hospital & Medical Center
Burlington, Massachusetts 01805
United States
North Mississippi Medical Center
Tupelo, Mississippi 38801
United States
Dartmouth Hitchcock
Lebanon, New Hampshire 03756
United States
Cooper Health
Camden, New Jersey 08103
United States
St. Joseph's
Liverpool, New York 13088
United States
Northwell Health
Manhasset, New York 11030
United States
Mount Sinai
New York, New York 10029
United States
TriHealth
Cincinnati, Ohio 45242
United States
Miami Valley/Wright State University/Premier Health
Dayton, Ohio 45435
United States
Jobst Vascular Institute - ProMedica Hospital
Toledo, Ohio 43606
United States
Temple University
Philadelphia, Pennsylvania 19140
United States
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United States
Sentara
Norfolk, Virginia 23507
United States
Charleston Area Medical Center
Charleston, West Virginia 25304
United States