NCT06433011 · Thrombolex, Inc.
The RAPID - PE Study: RESCUE Advanced Protocol for the Treatment of Pulmonary Embolism
What this study is about
To demonstrate the effectiveness 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).
View original scientific description
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).
Interventions
DEVICE
The Bashir™ Endovascular Catheter
The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery and peripheral vasculature.
DRUG
r-tPA
Pulse spray and infusion
Primary outcome measures
Efficacy: Death from any cause or hemodynamic decompensation (or collapse)
Time frame: Procedure through 7-day follow-up
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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;
- 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
- Scottsdale, Arizona
- Tuscon, Arizona
- Lakeland, Florida
- Atlanta, Georgia
- Chicago, Illinois
- Hobart, Indiana
- Indianapolis, Indiana
- Boston, Massachusetts
- Burlington, Massachusetts
- Tupelo, Mississippi
- Lebanon, New Hampshire
- Camden, New Jersey
And 10 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 14, 2026 · Source of record for eligibility and locations