Frontlight ResearchEarly access
Taking people in United StatesNo phase
The RAPID - PE Study: RESCUE Advanced Protocol for the Treatment of Pulmonary Embolism
Key facts
- Who runs it
- Thrombolex, Inc.
- Where
- Atlanta, Boston, Burlington, Camden, Charleston, Chicago, Cincinnati, Dayton, Hobart, Indianapolis, Lakeland, Lebanon, Liverpool, Manhasset, Nashville, New York, Norfolk, Philadelphia, Scottsdale, Toledo, Tupelo, and Tuscon, United StatesSee the 23 sites
- Trial code
- Status
- Recruiting
- People taking part
- 500 people, planned
- Started
- 17 Oct 2024
- Expected to end
- 25 Apr 2028
- Type of study
- Interventional
- Treatments tested
- The Bashir™ Endovascular Catheter
- r-tPA
- Record updated
- 14 July 2026
Who can take part
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 20 criteriaShow less
Who can take part
- 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
Who cannot take part
- Previous history of stroke with residual hemiplegia
- Major surgery ≤ 10 days prior to inclusion in the study
- Pulmonary thrombectomy within the previous 4 days
- Administration of thrombolytic agents 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
- Clinician deems high-risk for catastrophic bleeding
- Cardiac arrest (including pulseless electrical activity (PEA) and asystole) requiring active cardiopulmonary resuscitation (CPR) during this hospitalization at treating institution and/or referring institution
- Platelet count < 100,000/μL
- Absolute contraindication to anticoagulation
- Pregnancy
- Any vasopressor or inotropic support
- 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 in United States
- Emory UniversityAtlanta, United StatesContact: Pratik SandesaraTaking people
- Beth Israel Deaconess Medical CenterBoston, United StatesContact: Jeffrey WeinsteinTaking people
- Boston Medical CenterBoston, United StatesContact: Tariq BhatTaking people
- Lahey Hospital & Medical CenterBurlington, United StatesContact: Michael LevyTaking people
- Cooper HealthCamden, United StatesContact: Elias IliadisTaking people
- Charleston Area Medical CenterCharleston, United StatesContact: Mohammad EslamiTaking people
- Rush University Medical CenterChicago, United StatesContact: Bulent ArslanTaking people
- TriHealthCincinnati, United StatesContact: Adam ReichardTaking people
- Miami Valley/Wright State University/Premier HealthDayton, United StatesContact: Ryan BrandtTaking people
- Profound ResearchHobart, United StatesContact: Anas SafadiTaking people
- Community HealthIndianapolis, United StatesContact: Michael RobertsonTaking people
- Radiology and Imaging SpecialistsLakeland, United StatesContact: Kurt GordonTaking people
- Dartmouth HitchcockLebanon, United StatesContact: Michael YoungTaking people
- St. Joseph'sLiverpool, United StatesContact: Ayman IskanderTaking people
- Northwell HealthManhasset, United StatesContact: Vincent GalloTaking people
- Vanderbilt University Medical CenterNashville, United StatesContact: Alexander SullivanTaking people
- Mount SinaiNew York, United StatesContact: Jenanan VairavamurthyTaking people
- SentaraNorfolk, United StatesContact: David DexterTaking people
- Temple UniversityPhiladelphia, United StatesContact: Parth RaliTaking people
- Honor HealthScottsdale, United StatesContact: Chintan PatelTaking people
- Jobst Vascular Institute - ProMedica HospitalToledo, United StatesContact: Ahmad YounesTaking people
- North Mississippi Medical CenterTupelo, United StatesContact: Barry BertoletTaking people
- Carondelet St. Joseph's HospitalTuscon, United StatesContact: Sundeep ShenoyTaking people
About the trial
What the trial wants to find out
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).
The group in the trial
- BEC TreatmentTreatment being tested
The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery.
Treatment: The Bashir™ Endovascular Catheter and r-tPA
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- The RAPID - PE Study: RESCUE Advanced Protocol Without ICU Stay and no Lytic Drip - for the Treatment of Pulmonary Embolism
- Record updated
- 14 July 2026