The Bashir™ Endovascular Catheter: The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery and peripheral vasculature.
r-tPA: Pulse spray and infusion
Study 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).
Eligibility
Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria
1. Willing and able to provide informed consent;
2. PE symptom duration ≤ 15 days;
3. Filling defect in at least one major lobar pulmonary artery as determined by CTA;
4. Patient is diagnosed with intermediate risk PE;
5. RV/LV diameter ratio ≥ 0.9 by CTA, as determined by investigative site;
6. Willing and able to comply with all study procedures and 7-day and 30-day telephone follow-up visit.
Exclusion Criteria:
1. Previous history of stroke with residual hemiplegia;
2. Major surgery ≤ 10 days prior to inclusion in the study;
3. Platelet count \< 100,000/μL;
4. Pulmonary thrombectomy within the previous 4 days;
5. Uncontrolled hypertension defined as systolic blood pressure \>180 mm Hg and/or diastolic blood pressure \>110 mm Hg at the time of the procedure;
6. Administration of thrombolytic agents within the previous 4 days;
7. Absolute contraindication to anticoagulation;
8. Clinician deems high-risk for catastrophic bleeding;
9. Pregnancy;
10. Any vasopressor or inotropic support;
11. Cardiac arrest (including pulseless electrical activity (PEA) and asystole) requiring active cardiopulmonary resuscitation (CPR) during this hospitalization at treating institution and/or referring institution;
12. Planning to administer r-tPA by infusion after the r-tPA is administered by pulse sprays;
13. Currently participating in another study;
14. In the opinion of the investigator, the subject is not a suitable candidate for the study.
Primary outcome measure(s)
Efficacy: Death from any cause or hemodynamic decompensation (or collapse) — Procedure through 7-day follow-up 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).
Trial sites (23)
Facility
City
Region
Status
Honor Health
Scottsdale
Arizona
Recruiting
Carondelet St. Joseph's Hospital
Tuscon
Arizona
Recruiting
Radiology and Imaging Specialists
Lakeland
Florida
Recruiting
Emory University
Atlanta
Georgia
Recruiting
Rush University Medical Center
Chicago
Illinois
Recruiting
Profound Research
Hobart
Indiana
Recruiting
Community Health
Indianapolis
Indiana
Recruiting
Boston Medical Center
Boston
Massachusetts
Recruiting
Beth Israel Deaconess Medical Center
Boston
Massachusetts
Recruiting
Lahey Hospital & Medical Center
Burlington
Massachusetts
Recruiting
North Mississippi Medical Center
Tupelo
Mississippi
Recruiting
Dartmouth Hitchcock
Lebanon
New Hampshire
Recruiting
Cooper Health
Camden
New Jersey
Recruiting
St. Joseph's
Liverpool
New York
Recruiting
Northwell Health
Manhasset
New York
Recruiting
Mount Sinai
New York
New York
Recruiting
TriHealth
Cincinnati
Ohio
Recruiting
Miami Valley/Wright State University/Premier Health
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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