The RAPID - PE Study: RESCUE Advanced Protocol for the Treatment of Pulmonary Embolism

July 13, 2026 updated by: Thrombolex, Inc.

The RAPID - PE Study: RESCUE Advanced Protocol Without ICU Stay and no Lytic Drip - for the Treatment of Pulmonary Embolism

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The BASHIR™ .035 Endovascular Catheter (BEC) and the BEC Short Basket .035 (S-B) are devices intended for the localized infusion of therapeutic agents into the pulmonary artery and peripheral vasculature. The distal infusion segment of the device contains an expandable radial array of conduits with a total of 48 laser drilled orifices used for the delivery of the therapeutic agents at multiple cross-sectional points of the target vessel location. The infusion segment can be expanded and collapsed by the actuator (slider) located on the handle at the proximal end of the device. The infusion line connector is also located on the handle. The difference between the BEC .035 and the BEC S-B.035 is solely in the length of the basket. In its unexpanded state, the basket of the BEC .035 is 12.5cm long and the BEC S-B .035 basket is 10cm long. The choice of device used will be at the physician's discretion based on the patient's anatomy.

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Recruiting
        • Honor Health
        • Contact:
          • Chintan Patel
          • Phone Number: 480-323-1046
      • Tuscon, Arizona, United States, 85711
        • Recruiting
        • Carondelet St. Joseph's Hospital
        • Contact:
          • Sundeep Shenoy
          • Phone Number: 520-873-1591
    • Florida
      • Lakeland, Florida, United States, 33801
        • Recruiting
        • Radiology and Imaging Specialists
        • Contact:
          • Kurt Gordon
          • Phone Number: 135 "863-688-2334
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Recruiting
        • Emory University
        • Contact:
          • Pratik Sandesara
          • Phone Number: 404-686-7468
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Rush University Medical Center
        • Contact:
          • Bulent Arslan
          • Phone Number: 434-242-8364
    • Indiana
      • Hobart, Indiana, United States, 46342
        • Recruiting
        • Profound Research
        • Contact:
          • Anas Safadi
      • Indianapolis, Indiana, United States, 46256
        • Recruiting
        • Community Health
        • Contact:
          • Michael Robertson
          • Phone Number: 317-621-7724
    • Massachusetts
      • Boston, Massachusetts, United States, 02135
        • Recruiting
        • Boston Medical Center
        • Contact:
          • Tariq Bhat
          • Phone Number: 617-779-6731
      • Boston, Massachusetts, United States, 02481
        • Recruiting
        • Beth Israel Deaconess Medical Center
        • Contact:
          • Jeffrey Weinstein
          • Phone Number: 617-754-2523
      • Burlington, Massachusetts, United States, 01805
        • Recruiting
        • Lahey Hospital & Medical Center
        • Contact:
          • Michael Levy
          • Phone Number: 781-744-8460
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • Recruiting
        • North Mississippi Medical Center
        • Contact:
          • Barry Bertolet
          • Phone Number: 662-213-0405
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Recruiting
        • Dartmouth Hitchcock
        • Contact:
          • Michael Young
          • Phone Number: 615-927-9043
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Recruiting
        • Cooper Health
        • Contact:
          • Elias Iliadis
          • Phone Number: 856-757-7832
    • New York
      • Liverpool, New York, United States, 13088
        • Recruiting
        • St. Joseph's
        • Contact:
          • Ayman Iskander
          • Phone Number: 315-234-4412
      • Manhasset, New York, United States, 11030
        • Recruiting
        • Northwell Health
        • Contact:
          • Vincent Gallo
          • Phone Number: 718-226-6422
      • New York, New York, United States, 10029
        • Recruiting
        • Mount Sinai
        • Contact:
          • Jenanan Vairavamurthy
          • Phone Number: 212-659-9151
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Recruiting
        • TriHealth
        • Contact:
          • Adam Reichard
          • Phone Number: 513-865-9898
      • Dayton, Ohio, United States, 45435
        • Recruiting
        • Miami Valley/Wright State University/Premier Health
        • Contact:
          • Ryan Brandt
          • Phone Number: 937-208-3689
      • Toledo, Ohio, United States, 43606
        • Recruiting
        • Jobst Vascular Institute - ProMedica Hospital
        • Contact:
          • Ahmad Younes
          • Phone Number: 419-291-2111
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Recruiting
        • Temple University
        • Contact:
          • Parth Rali
          • Phone Number: 215-707-1359
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center
        • Contact:
          • Alexander Sullivan
          • Phone Number: 615-343-8647
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Recruiting
        • Sentara
        • Contact:
          • David Dexter
          • Phone Number: 757-395-1600
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • Recruiting
        • Charleston Area Medical Center
        • Contact:
          • Mohammad Eslami
          • Phone Number: 304-388-5432

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  1. Willing and able to provide informed consent;
  2. PE symptom duration ≤ 15 days;
  3. Filling defect in at least one major lobar pulmonary artery as determined by CTA;
  4. Patient is diagnosed with intermediate risk PE;
  5. RV/LV diameter ratio ≥ 0.9 by CTA, as determined by investigative site;
  6. Willing and able to comply with all study procedures and 7-day and 30-day telephone follow-up visit.

Exclusion Criteria:

  1. Previous history of stroke with residual hemiplegia;
  2. Major surgery ≤ 10 days prior to inclusion in the study;
  3. Platelet count < 100,000/μL;
  4. Pulmonary thrombectomy within the previous 4 days;
  5. Uncontrolled hypertension defined as systolic blood pressure >180 mm Hg and/or diastolic blood pressure >110 mm Hg at the time of the procedure;
  6. Administration of thrombolytic agents within the previous 4 days;
  7. Absolute contraindication to anticoagulation;
  8. Clinician deems high-risk for catastrophic bleeding;
  9. Pregnancy;
  10. Any vasopressor or inotropic support;
  11. Cardiac arrest (including pulseless electrical activity (PEA) and asystole) requiring active cardiopulmonary resuscitation (CPR) during this hospitalization at treating institution and/or referring institution;
  12. Planning to administer r-tPA by infusion after the r-tPA is administered by pulse sprays;
  13. Currently participating in another study;
  14. In the opinion of the investigator, the subject is not a suitable candidate for the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BEC Treatment
The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery.
Drug: r-tPA
Pulse spray and infusion
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Procedure through 7-day follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thrombolex, Inc.

Investigators

  • Study Director: Karen Stephens, Thrombolex, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 17, 2024

Primary Completion (Estimated)

April 25, 2028

Study Completion (Estimated)

April 25, 2028

Study Registration Dates

First Submitted

May 22, 2024

First Submitted That Met QC Criteria

May 22, 2024

First Posted (Actual)

May 29, 2024

Study Record Updates

Last Update Posted (Actual)

July 14, 2026

Last Update Submitted That Met QC Criteria

July 13, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • THRO-CLIN-2024-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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