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

Thrombolex, Inc. · NCT06433011

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Any age listed · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
500
US sites recruiting
23
Study start
October 17, 2024
Record last updated
July 14, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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).

Being studied: The Bashir™ Endovascular Catheter; r-tPA

Conditions: Pulmonary Embolism

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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;
  • 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.

Recruiting US locations

  • Honor Health

    Scottsdale, AZ 85258

    Site contact: Chintan Patel · 480-323-1046

  • Carondelet St. Joseph's Hospital

    Tuscon, AZ 85711

    Site contact: Sundeep Shenoy · 520-873-1591

  • Radiology and Imaging Specialists

    Lakeland, FL 33801

    Site contact: Kurt Gordon · "863-688-2334

  • Emory University

    Atlanta, GA 30308

    Site contact: Pratik Sandesara · 404-686-7468

  • Rush University Medical Center

    Chicago, IL 60612

    Site contact: Bulent Arslan · 434-242-8364

  • Profound Research

    Hobart, IN 46342

    Site contact: Anas Safadi

  • Community Health

    Indianapolis, IN 46256

    Site contact: Michael Robertson · 317-621-7724

  • Boston Medical Center

    Boston, MA 02135

    Site contact: Tariq Bhat · 617-779-6731

  • Beth Israel Deaconess Medical Center

    Boston, MA 02481

    Site contact: Jeffrey Weinstein · 617-754-2523

  • Lahey Hospital & Medical Center

    Burlington, MA 01805

    Site contact: Michael Levy · 781-744-8460

  • North Mississippi Medical Center

    Tupelo, MS 38801

    Site contact: Barry Bertolet · 662-213-0405

  • Dartmouth Hitchcock

    Lebanon, NH 03756

    Site contact: Michael Young · 615-927-9043

  • Cooper Health

    Camden, NJ 08103

    Site contact: Elias Iliadis · 856-757-7832

  • St. Joseph's

    Liverpool, NY 13088

    Site contact: Ayman Iskander · 315-234-4412

  • Northwell Health

    Manhasset, NY 11030

    Site contact: Vincent Gallo · 718-226-6422

  • Mount Sinai

    New York, NY 10029

    Site contact: Jenanan Vairavamurthy · 212-659-9151

  • TriHealth

    Cincinnati, OH 45242

    Site contact: Adam Reichard · 513-865-9898

  • Miami Valley/Wright State University/Premier Health

    Dayton, OH 45435

    Site contact: Ryan Brandt · 937-208-3689

  • Jobst Vascular Institute - ProMedica Hospital

    Toledo, OH 43606

    Site contact: Ahmad Younes · 419-291-2111

  • Temple University

    Philadelphia, PA 19140

    Site contact: Parth Rali · 215-707-1359

  • Vanderbilt University Medical Center

    Nashville, TN 37232

    Site contact: Alexander Sullivan · 615-343-8647

  • Sentara

    Norfolk, VA 23507

    Site contact: David Dexter · 757-395-1600

  • Charleston Area Medical Center

    Charleston, WV 25304

    Site contact: Mohammad Eslami · 304-388-5432

Study contacts (from the official record)

  • Chris Schultz, BS · 971-506-7552 · cschultz@ecr-inc.com
  • Craig Dull, MS · 314-315-6264 · cdull@ecr-inc.com
The RAPID - PE Study: RESCUE Advanced Protocol for the Treatment… (NCT06433011) | Bored Studies