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

RecruitingNAAges any - anyAllThrombolex, Inc.
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In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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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What it tests

  • The Bashir™ Endovascular Catheter
  • r-tPA
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Where

23 sites
Honor Health
Scottsdale, United States
Carondelet St. Joseph's Hospital
Tuscon, United States
Radiology and Imaging Specialists
Lakeland, United States
Emory University
Atlanta, United States
Rush University Medical Center
Chicago, United States
Profound Research
Hobart, United States
Community Health
Indianapolis, United States
Boston Medical Center
Boston, United States

…and 15 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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