The RAPID - PE Study: RESCUE Advanced Protocol for the Treatment of Pulmonary Embolism
ConditionPulmonary Embolism
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorThrombolex, Inc.
About this trial
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 criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- The Bashir™ Endovascular Catheter
- r-tPA
Treatment groups
500 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov