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

NCT06433011 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: THRO-CLIN-2024-01
• Study Type: interventional
• Target: 500
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Pulmonary Embolism

Keywords

Pulmonary Embolism; Catheter Directed Therapy

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

EXPERIMENTAL

The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery.

Device: The Bashir™ Endovascular Catheter; Drug: r-tPA

Interventions

The Bashir™ Endovascular Catheter DEVICE

The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery and peripheral vasculature.

BEC Treatment

r-tPA DRUG

Pulse spray and infusion

BEC Treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Thrombolex, Inc.: lead

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jeff Mifek

  Thrombolex, Inc.

  STUDY DIRECTOR

Central Study Contacts

Chris Schultz, BS

CONTACT

971-506-7552; cschultz@ecr-inc.com

Lynn Begovac, MS

CONTACT

928-600-3599; lbegovac@ecr-inc.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single Group Assignment Pulse Spray and Infusion of r-tPA

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: May 29, 2024
• Study Start: June 25, 2024
• Primary Completion (Estimated): June 25, 2027
• Study Completion (Estimated): August 25, 2027
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share