Status:
UNKNOWN
The RESCUE II Study. The Bashir™ Endovascular Catheter (BEC),
Lead Sponsor:
Temple University
Conditions:
Acute Submassive Pulmonary Embolism
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
To demonstrate the efficacy and safety of the Bashir™ Endovascular Catheter for the administration of pharmaco-mechanical catheter directed therapy using pulse spray of r-tPA for the treatment of acut...
Detailed Description
Study Objective To demonstrate the efficacy and safety of the Bashir™ and Bashir™ S-B Endovascular Catheters for the administration of pharmaco- mechanical catheter directed therapy in a pulse spray m...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Willing and able to provide informed consent;
- Age 18 to ≤ 75 years of age;
- PE symptom duration ≤ 14 days.
- Filling defect in at least one main or lobar pulmonary artery as determined by CTA;
- RV/LV diameter ratio ≥ 0.9 by CTA as determined by the investigative site;
- Willing and able to comply with all study procedures and follow-up
Exclusion
- CVA or TIA within one (1) year;
- Head trauma, active intracranial, or intraspinal disease ≤ one (1) year prior to inclusion in the study;
- Active bleeding from a major organ within one (1) month prior to inclusion in the study;
- Intracranial condition(s) that may increase the risk of bleeding (e.g., neoplasms, arteriovenous malformations, or aneurysms);
- Patients with bleeding diatheses;
- Hematocrit \< 30%;
- Platelets \< 100,000/μL;
- INR \> 1.5 if currently on warfarin (Coumadin®);
- aPTT \> 50 seconds in the absence of anticoagulants;
- Major surgery ≤ 14 days prior to inclusion in the study;
- Serum creatinine \> 2.0mg/dL;
- Clinician deems high-risk for catastrophic bleeding;
- History of heparin-induced thrombocytopenia (HIT Syndrome);
- Pregnancy;
- SBP \< 90 mmHg \> 15 minutes within two (2) hours prior to BEC procedure and is not resolved with IV fluids;
- Any vasopressor support;
- Cardiac arrest (including pulseless electrical activity and asystole) requiring active cardiopulmonary resuscitation (CPR) during this hospitalization at treating institution and/or referring institution;
- Evidence of irreversible neurological compromise;
- Life expectancy \< one (1) year;
- Use of thrombolytics or glycoprotein IIb/IIIa inhibitor within 3 days prior to inclusion in the study;
- Profound bradycardia requiring a temporary pacemaker and/or inotropic support;
- Absolute contraindication to anticoagulation;
- Uncontrolled hypertension defined as SBP \> 175mmHg and / or DBP \> 110mmHg with pharmacotherapy within two (2) hours prior to inclusion in the study;
- Currently participating in another study;
- In the opinion of the investigator, the subject is not a suitable candidate for the study
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06120179
Start Date
November 1 2023
End Date
January 1 2025
Last Update
November 7 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Temple University
Philadelphia, Pennsylvania, United States, 19140