The RAPID - PE Study: RESCUE Advanced Protocol for the Treatment of Pulmonary Embolism
Recruiting now · Not applicable
Conditions studied: Pulmonary Embolism
In brief
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).
Key facts
- Study ID
- NCT06433011
- Run by
- Thrombolex, Inc.
- People needed
- 500
- Starts
- 2024-10-17
- Expected to finish
- 2028-04-25
- Last updated by the study team
- 2026-07-14
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Honor Health — Scottsdale, Arizona, United States (enrolling)
- Carondelet St. Joseph's Hospital — Tuscon, Arizona, United States (enrolling)
- Radiology and Imaging Specialists — Lakeland, Florida, United States (enrolling)
- Emory University — Atlanta, Georgia, United States (enrolling)
- Rush University Medical Center — Chicago, Illinois, United States (enrolling)
- Profound Research — Hobart, Indiana, United States (enrolling)
- Community Health — Indianapolis, Indiana, United States (enrolling)
- Boston Medical Center — Boston, Massachusetts, United States (enrolling)
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (enrolling)
- Lahey Hospital & Medical Center — Burlington, Massachusetts, United States (enrolling)
- North Mississippi Medical Center — Tupelo, Mississippi, United States (enrolling)
- Dartmouth Hitchcock — Lebanon, New Hampshire, United States (enrolling)
- Cooper Health — Camden, New Jersey, United States (enrolling)
- St. Joseph's — Liverpool, New York, United States (enrolling)
- Northwell Health — Manhasset, New York, United States (enrolling)
- Mount Sinai — New York, New York, United States (enrolling)
- TriHealth — Cincinnati, Ohio, United States (enrolling)
- Miami Valley/Wright State University/Premier Health — Dayton, Ohio, United States (enrolling)
- Jobst Vascular Institute - ProMedica Hospital — Toledo, Ohio, United States (enrolling)
- Temple University — Philadelphia, Pennsylvania, United States (enrolling)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)
- Sentara — Norfolk, Virginia, United States (enrolling)
- Charleston Area Medical Center — Charleston, West Virginia, United States (enrolling)
Full record on ClinicalTrials.gov
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