Clinical trial NCT03927508: First - In - Man Study to Assess the Safety and Feasibility of The Bashir™ Endovascular Catheter for the Treatment of Acute Pulmonary Embolism
Official title: First - In - Man Study to Assess the Safety and Feasibility of The Bashir™ Endovascular Catheter for the Treatment of Acute Pulmonary Embolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pulmonary Embolism
Keywords: Pulmonary Embolism
Lead sponsor: Thrombolex, Inc.
Sponsor class: INDUSTRY
First posted: 2019-04-25
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pulse Spray and Infusion of r-tPA
Primary purpose: TREATMENT

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

Detailed description: The Bashir™ Endovascular Catheter has been designed to administer therapeutic agents in the peripheral vasculature. Because of the unique design of the catheter, with its six expandable infusion limbs, the Bashir™ Endovascular Catheter has the ability to: 1. Create a much larger central channel for blood flow, thereby utilizing the body's own endogenous fibrinolytic agents to lyse the clot, and 2. Greatly enhance the radial dispersion of a catheter-administered thrombolytic agent throughout the thrombus. Expansion of the multiple arms of the basket in the infusion catheter causes fissuring of the clot. The net result is that a greater surface area of clot is exposed to both endogenous and exogenously administered lytic agents, thereby promoting clot dissolution.

Eligibility criteria: Inclusion Criteria:

General Inclusion Criteria:

1. Willing and able to provide informed consent;
2. 18 years of age and less than 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 contrast enhanced chest CT;
5. RV/LV end diastolic 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. Cerebrovascular Accident (CVA) or transient ischemic attack (TIA) within one (1) year;
2. Head trauma, or other active intracranial, or intraspinal disease within one (1) year;
3. Recent (within one month) or active bleeding from a major organ;
4. Intracranial condition(s) that may increase the risk of bleeding (e.g., neoplasms, arteriovenous malformations, or aneurysms);
5. Patients with bleeding diathesis;
6. Hematocrit \< 30%;
7. Platelets \< 100,000/μL;
8. INR \> 1.5;
9. aPTT \> 50 seconds in the absence of anticoagulants;
10. Major surgery within fourteen (14) days;
11. Serum creatinine \> 2 mg/dL;
12. Clinician deems high-risk for catastrophic bleeding;
13. History of heparin-induced thrombocytopenia (HIT);
14. Pregnancy;
15. Systolic blood pressure \< 90 mmHg for \> 15 minutes;
16. Any vasopressor support;
17. Cardiac arrest (including pulseless electrical activity and asystole) requiring active cardiopulmonary resuscitation (CPR);
18. Evidence of irreversible neurological compromise;
19. Life expectancy \< one (1) year;
20. Use of thrombolytics or glycoprotein IIb/IIIa antagonists within 3 days prior to inclusion in the study;
21. Use of non-vitamin K oral anti-coagulants (NOACs), such as Rivaroxaban, Apixaban, Dabigatran, Edoxaban within 48 hours prior to inclusion in the study;
22. Use of enoxaparin sodium injection (Lovenox®) within 12 hours of procedure start time;
23. Profound bradycardia requiring a temporary pacemaker and/or inotropic support;
24. Previous enrollment in this study;
25. Morbidly obese (BMI \>45 kg/m2) patient who by the judgement of the investigator is high risk for bleeding;
26. Absolute contraindication to anticoagulation;
27. Uncontrolled hypertension;
28. Currently participating in another study;
29. In the opinion of the investigator, the subject is not a suitable candidate for the study.

Primary outcomes:
measure: Safety: Number of Participants With Major Bleeding Events
timeFrame: Within 72 hours of initiation of r-tPA administration.
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Advent Health Orlando
state: Florida
city: Indianapolis
country: United States
facility: St Vincent Hospital and Health Care Center, Inc.
state: Indiana
city: New York
country: United States
facility: Columbia University Medical Center - Presbyterian - New York
state: New York
city: Erie
country: United States
facility: University Pittsburg Medical Center - Hamot
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
Study officials:
References:
citation: Sista AK, Bhatheja R, Rali P, Natarajan K, Green P, Piazza G, Comerota AJ, Parikh SA, Lakhter V, Bashir R, Rosenfield K. First-in-Human Study to Assess the Safety and Feasibility of the Bashir Endovascular Catheter for the Treatment of Acute Intermediate-Risk Pulmonary Embolism. Circ Cardiovasc Interv. 2021 Jan;14(1):e009611. doi: 10.1161/CIRCINTERVENTIONS.120.009611. Epub 2020 Dec 24.