Overview
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).
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
Inclusion Criteria
- Willing and able to provide informed consent;
- PE symptom duration ≤ 15 days;
- Filling defect in at least one major lobar pulmonary artery as determined by CTA;
- Patient is diagnosed with intermediate risk PE;
- RV/LV diameter ratio ≥ 0.9 by CTA, as determined by investigative site;
- Willing and able to comply with all study procedures and 7-day and 30-day telephone follow-up visit.
Exclusion Criteria:
- Previous history of stroke with residual hemiplegia;
- Major surgery ≤ 10 days prior to inclusion in the study;
- Platelet count \< 100,000/μL;
- Pulmonary thrombectomy within the previous 4 days;
- Uncontrolled hypertension defined as systolic blood pressure \>180 mm Hg and/or diastolic blood pressure \>110 mm Hg at the time of the procedure;
- Administration of thrombolytic agents within the previous 4 days;
- Absolute contraindication to anticoagulation;
- Clinician deems high-risk for catastrophic bleeding;
- Pregnancy;
- Any vasopressor or inotropic support;
- Cardiac arrest (including pulseless electrical activity (PEA) and asystole) requiring active cardiopulmonary resuscitation (CPR) during this hospitalization at treating institution and/or referring institution;
- Planning to administer r-tPA by infusion after the r-tPA is administered by pulse sprays;
- Currently participating in another study;
- In the opinion of the investigator, the subject is not a suitable candidate for the study.
