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

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: Not yet recruiting
• Conditions: Pulmonary Embolism
• Intervention / Treatment: Drug: r-tPA; Device: The Bashir™ Endovascular Catheter

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

• Study Contact: Name: Chris Schultz, BS; Phone Number: 971-506-7552; Email: cschultz@ecr-inc.com
• Study Contact Backup: Name: Lynn Begovac, MS; Phone Number: 928-600-3599; Email: lbegovac@ecr-inc.com

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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)	Observe death from any cause or hemodynamic decompensation (or collapse) through 7-day follow-up, defined as need for cardiopulmonary resuscitation; or; SBP < 90 mmHg for at least 15 minutes; or; 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; 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

• Sponsor: Thrombolex, Inc.
• Investigators: Study Director: Jeff Mifek, Thrombolex, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): June 25, 2024
• Primary Completion (Estimated): June 25, 2027
• Study Completion (Estimated): August 25, 2027

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): May 29, 2024
• Last Update Submitted That Met QC Criteria: May 22, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Pulmonary Embolism; Catheter Directed Therapy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Pulmonary Embolism
• 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