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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
The Bashir™ Endovascular Catheter
DeviceThe Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery and peripheral vasculature.
r-tPA
DrugPulse spray and infusion
Treatment groups
500 Participants
are divided into 1 treatment groupGroup A: BEC TreatmentExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Efficacy: Death from any cause or hemodynamic decompensation (or collapse)
Observe death from any cause or hemodynamic decompensation (or collapse) through 7-day follow-up, defined as need for cardiopulmonary resuscitation; or 1. SBP \< 90 mmHg for at least 15 minutes; or 2. drop in SBP by at least 40 mmHg for at least 15 minutes with signs of end-organ hypoperfusion (cold extremities or low urinary output \< 30 mL/h or mental confusion); or 3. need for catecholamine administration to maintain adequate organ perfusion and a SBP \> 90 mmHg (including dopamine at the rate of \> 5 micrograms / kg per minute).
Time frame
Procedure through 7-day follow-upSponsors and contacts
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Source ClinicalTrials.gov