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).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
500
The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery and peripheral vasculature.
Pulse spray and infusion
Honor Health
Scottsdale, Arizona, United States
Efficacy: Death from any cause or hemodynamic decompensation (or collapse)
Observe death from any cause or hemodynamic decompensation (or collapse) through 7-day follow-up, defined as need for cardiopulmonary resuscitation; or 1. SBP \< 90 mmHg for at least 15 minutes; or 2. drop in SBP by at least 40 mmHg for at least 15 minutes with signs of end-organ hypoperfusion (cold extremities or low urinary output \< 30 mL/h or mental confusion); or 3. need for catecholamine administration to maintain adequate organ perfusion and a SBP \> 90 mmHg (including dopamine at the rate of \> 5 micrograms / kg per minute).
Time frame: Procedure through 7-day follow-up
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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