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

Pulmonary Embolism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06433011
• Other study ID #: THRO-CLIN-2024-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 25, 2024
• Est. completion date: August 25, 2027

Study information

• Verified date: May 2024
• Source: Thrombolex, Inc.
• Contact: Chris Schultz, BS
• Phone: 971-506-7552
• Email: cschultz[@]ecr-inc.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: August 25, 2027
• Est. primary completion date: June 25, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Intervention

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.

Drug:
• r-tPA
Pulse spray and infusion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Thrombolex, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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