Pulmonary Embolism
Conditions
Keywords
Pulmonary Embolism
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.
Interventions
DRUGr-tPA
Pulse spray and infusion
The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery and peripheral vasculature.
Sponsors
Thrombolex, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Pulse Spray and Infusion of r-tPA
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety: Number of Participants With Major Bleeding Events | Within 72 hours of initiation of r-tPA administration. | Major Bleeding as defined by International Society of Thrombosis and Hemostasis (ISTH), within 72 hours of initiation of r-tPA administration. Bleeding criteria are as follows: Major Bleeding in Non-Surgical Patients 1. Fatal bleeding; and/or 2. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome; and/or 3. Bleeding causing a fall in hemoglobin level of 2 g/dL (1.24 mmol/L) or more or leading to transfusion of two or more units of whole blood or red cells. |
Countries
United States
Participant flow
Recruitment details
Enrollment took place over a period of four (4) months, July 19, 2019 - November 16, 2019. The date the study is was open for recruitment started March 14, 2019. Study was FDA approved for up to five (5) sites. Nine (9) subjects were enrolled and are included in this report through 30-day follow-up.
Participants by arm
| Arm | Count |
|---|---|
| BEC Treatment The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery.
r-tPA: Pulse spray and infusion
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. | 9 |
| Total | 9 |
Baseline characteristics
| Characteristic | BEC Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants |
| Age, Continuous | 43.67 years STANDARD_DEVIATION 11.64 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Region of Enrollment United States | 9 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 9 |
| other Total, other adverse events | 4 / 9 |
| serious Total, serious adverse events | 1 / 9 |
Outcome results
Primary
Safety: Number of Participants With Major Bleeding Events
Major Bleeding as defined by International Society of Thrombosis and Hemostasis (ISTH), within 72 hours of initiation of r-tPA administration. Bleeding criteria are as follows: Major Bleeding in Non-Surgical Patients 1. Fatal bleeding; and/or 2. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome; and/or 3. Bleeding causing a fall in hemoglobin level of 2 g/dL (1.24 mmol/L) or more or leading to transfusion of two or more units of whole blood or red cells.
Time frame: Within 72 hours of initiation of r-tPA administration.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BEC Treatment | Safety: Number of Participants With Major Bleeding Events | 1 Participants |