The RAPID - PE Study: RESCUE Advanced Protocol for the Treatment of Pulmonary Embolism

ID#: NCT06433011

Age: Birth - 66+

Gender: All

Healthy Subjects: No

Study Phase: N/A

Recruitment Status: Recruiting

Start Date: October 17, 2024

End Date: April 25, 2028

Contact Information:
Chris Schultz, BS
971-506-7552
Craig Dull, MS
314-315-6264
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: 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.
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