BASHIR Endovascular Catheter Therapy for Intermediate-Risk Pulmonary Embolism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This intervention study uses the Bashir .035 Endovascular Catheter to deliver pharmacologic therapy directly into the pulmonary arteries for patients with intermediate-risk PE. Two device options (BEC and BEC S-B) allow localized, multi-point delivery of rt-PA via pulse sprays. Eligibility requires confirmed intermediate-risk PE with specific imaging and functional criteria, and participants will be followed by phone at 7 and 30 days. The trial assesses safety and efficacy of catheter-directed, pharmaco-mechanical therapy in reducing embolic burden and improving right heart metrics. Lead sponsor is Thrombolex, Inc., with sites in Arizona and Florida.

Why it matters

Who can join: the full rules

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.

Where it's running

• Honor Health
  Scottsdale, Arizona, United States Recruiting
• Carondelet St. Joseph's Hospital
  Tuscon, Arizona, United States Recruiting
• Radiology and Imaging Specialists
  Lakeland, Florida, United States Recruiting
• Emory University
  Atlanta, Georgia, United States Recruiting
• Rush University Medical Center
  Chicago, Illinois, United States Recruiting
• Profound Research
  Hobart, Indiana, United States Recruiting

Study contacts

• Study coordinator: Chris Schultz, BS
• Email: cschultz@ecr-inc.com
• Phone: 971-506-7552

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.