The RAPID - PE Study: RESCUE Advanced Protocol for the Treatment of Pulmonary Embolism
1 other identifier
interventional
500
1 country
23
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2024
Longer than P75 for not_applicable
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2024
CompletedFirst Posted
Study publicly available on registry
May 29, 2024
CompletedStudy Start
First participant enrolled
October 17, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 25, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 25, 2028
July 14, 2026
July 1, 2026
3.5 years
May 22, 2024
July 13, 2026
Conditions
Keywords
Outcome Measures
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).
Procedure through 7-day follow-up
Study Arms (1)
BEC Treatment
EXPERIMENTALThe Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery.
Interventions
The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery and peripheral vasculature.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Previous history of stroke with residual hemiplegia;
- 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;
- Pregnancy;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Thrombolex, Inc.lead
Study Sites (23)
Honor Health
Scottsdale, Arizona, 85258, United States
Carondelet St. Joseph's Hospital
Tuscon, Arizona, 85711, United States
Radiology and Imaging Specialists
Lakeland, Florida, 33801, United States
Emory University
Atlanta, Georgia, 30308, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Profound Research
Hobart, Indiana, 46342, United States
Community Health
Indianapolis, Indiana, 46256, United States
Boston Medical Center
Boston, Massachusetts, 02135, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02481, United States
Lahey Hospital & Medical Center
Burlington, Massachusetts, 01805, United States
North Mississippi Medical Center
Tupelo, Mississippi, 38801, United States
Dartmouth Hitchcock
Lebanon, New Hampshire, 03756, United States
Cooper Health
Camden, New Jersey, 08103, United States
St. Joseph's
Liverpool, New York, 13088, United States
Northwell Health
Manhasset, New York, 11030, United States
Mount Sinai
New York, New York, 10029, United States
TriHealth
Cincinnati, Ohio, 45242, United States
Miami Valley/Wright State University/Premier Health
Dayton, Ohio, 45435, United States
Jobst Vascular Institute - ProMedica Hospital
Toledo, Ohio, 43606, United States
Temple University
Philadelphia, Pennsylvania, 19140, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Sentara
Norfolk, Virginia, 23507, United States
Charleston Area Medical Center
Charleston, West Virginia, 25304, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Karen Stephens
Thrombolex, Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2024
First Posted
May 29, 2024
Study Start
October 17, 2024
Primary Completion (Estimated)
April 25, 2028
Study Completion (Estimated)
April 25, 2028
Last Updated
July 14, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share