The RESCUE II Study. The Bashir™ Endovascular Catheter (BEC),

Launched by TEMPLE UNIVERSITY · Nov 1, 2023

Keywords

ClinConnect Summary

The RESCUE II Study is a clinical trial that aims to test a new device called the Bashir™ Endovascular Catheter (BEC) for treating a serious condition known as acute submassive pulmonary embolism, which is when blood clots block blood flow in the lungs. This trial will help researchers understand how effective and safe this device is when combined with a special medication that breaks down blood clots.

To participate in this study, individuals must be between the ages of 18 and 75, have experienced symptoms of a pulmonary embolism for 14 days or less, and have specific imaging results indicating a blockage in their pulmonary arteries. Participants will need to give their consent and agree to follow the study procedures. However, certain health conditions, such as recent major surgeries or active bleeding, may prevent someone from joining. The study is not yet recruiting participants, but it is important for those who may be interested to know what to expect and to discuss their eligibility with their healthcare provider.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Inclusion Criteria
• • 1. Willing and able to provide informed consent;
• • 2. Age 18 to ≤ 75 years of age;
• • 3. PE symptom duration ≤ 14 days.
• • 4. Filling defect in at least one main or lobar pulmonary artery as determined by CTA;
• • 5. RV/LV diameter ratio ≥ 0.9 by CTA as determined by the investigative site;
• • 6. Willing and able to comply with all study procedures and follow-up
• Exclusion Criteria:
• • 1. CVA or TIA within one (1) year;
• • 2. Head trauma, active intracranial, or intraspinal disease ≤ one (1) year prior to inclusion in the study;
• • 3. Active bleeding from a major organ within one (1) month prior to inclusion in the study;
• • 4. Intracranial condition(s) that may increase the risk of bleeding (e.g., neoplasms, arteriovenous malformations, or aneurysms);
• • 5. Patients with bleeding diatheses;
• • 6. Hematocrit \< 30%;
• • 7. Platelets \< 100,000/μL;
• • 8. INR \> 1.5 if currently on warfarin (Coumadin®);
• • 9. aPTT \> 50 seconds in the absence of anticoagulants;
• • 10. Major surgery ≤ 14 days prior to inclusion in the study;
• • 11. Serum creatinine \> 2.0mg/dL;
• • 12. Clinician deems high-risk for catastrophic bleeding;
• • 13. History of heparin-induced thrombocytopenia (HIT Syndrome);
• • 14. Pregnancy;
• • 15. SBP \< 90 mmHg \> 15 minutes within two (2) hours prior to BEC procedure and is not resolved with IV fluids;
• • 16. Any vasopressor support;
• • 17. Cardiac arrest (including pulseless electrical activity and asystole) requiring active cardiopulmonary resuscitation (CPR) during this hospitalization at treating institution and/or referring institution;
• • 18. Evidence of irreversible neurological compromise;
• • 19. Life expectancy \< one (1) year;
• • 20. Use of thrombolytics or glycoprotein IIb/IIIa inhibitor within 3 days prior to inclusion in the study;
• • 21. Profound bradycardia requiring a temporary pacemaker and/or inotropic support;
• • 22. Absolute contraindication to anticoagulation;
• • 23. Uncontrolled hypertension defined as SBP \> 175mmHg and / or DBP \> 110mmHg with pharmacotherapy within two (2) hours prior to inclusion in the study;
• • 24. Currently participating in another study;
• • 25. In the opinion of the investigator, the subject is not a suitable candidate for the study