Pulmonary Embolism Clinical Trial
Official title:
First - In - Man Study to Assess the Safety and Feasibility of The Bashir™ Endovascular Catheter for the Treatment of Acute Pulmonary Embolism
Verified date | March 2023 |
Source | Thrombolex, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery and peripheral vasculature.
Status | Completed |
Enrollment | 9 |
Est. completion date | January 23, 2020 |
Est. primary completion date | December 19, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | University Pittsburg Medical Center - Hamot | Erie | Pennsylvania |
United States | St Vincent Hospital and Health Care Center, Inc. | Indianapolis | Indiana |
United States | Columbia University Medical Center - Presbyterian - New York | New York | New York |
United States | Advent Health Orlando | Orlando | Florida |
United States | Temple University Hospital | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Thrombolex, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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 Fatal bleeding; and/or Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome; and/or 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. |
Within 72 hours of initiation of r-tPA administration. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05050617 -
Point-of-Care Ultrasound in Predicting Adverse Outcomes in Emergency Department Patients With Acute Pulmonary Embolism
|
||
Terminated |
NCT04558125 -
Low-Dose Tenecteplase in Covid-19 Diagnosed With Pulmonary Embolism
|
Phase 4 | |
Not yet recruiting |
NCT06017271 -
Predictive Value of Epicardial Adipose Tissue for Pulmonary Embolism and Death in Patients With Lung Cancer
|
||
Completed |
NCT03915925 -
Short-term Clinical Deterioration After Acute Pulmonary Embolism
|
||
Completed |
NCT02502396 -
Rivaroxaban Utilization for Treatment and Prevention of Thromboembolism in Cancer Patients: Experience at a Comprehensive Cancer Center
|
||
Recruiting |
NCT05171075 -
A Study Comparing Abelacimab to Dalteparin in the Treatment of Gastrointestinal/Genitourinary Cancer and Associated VTE
|
Phase 3 | |
Completed |
NCT04454554 -
Prevalence of Pulmonary Embolism in Patients With Dyspnea on Exertion (PEDIS)
|
||
Completed |
NCT03173066 -
Ferumoxytol as a Contrast Agent for Pulmonary Magnetic Resonance Angiography
|
Phase 1 | |
Terminated |
NCT03002467 -
Impact Analysis of Prognostic Stratification for Pulmonary Embolism
|
N/A | |
Completed |
NCT02611115 -
Optimizing Protocols for the Individual Patient in CT Pulmonary Angiography.
|
N/A | |
Completed |
NCT02334007 -
Extended Low-Molecular Weight Heparin VTE Prophylaxis in Thoracic Surgery
|
Phase 1/Phase 2 | |
Completed |
NCT01975090 -
The SENTRY Clinical Study
|
N/A | |
Not yet recruiting |
NCT01357941 -
Need for Antepartum Thromboprophylaxis in Pregnant Women With One Prior Episode of Venous Thromboembolism (VTE)
|
N/A | |
Completed |
NCT01326507 -
Prognostic Value of Heart-type Fatty Acid-Binding Protein (h-FABP) in Acute Pulmonary Embolism
|
N/A | |
Completed |
NCT02476526 -
Safety of Low Dose IV Contrast CT Scanning in Chronic Kidney Disease
|
Phase 4 | |
Completed |
NCT00773448 -
Screening for Occult Malignancy in Patients With Idiopathic Venous Thromboembolism
|
N/A | |
Completed |
NCT00720915 -
D-dimer to Select Patients With First Unprovoked Venous Thromboembolism Who Can Have Anticoagulants Stopped at 3 Months
|
N/A | |
Completed |
NCT00780767 -
Angiojet Rheolytic Thrombectomy in Case of Massive Pulmonary Embolism
|
Phase 2 | |
Completed |
NCT00771303 -
Ruling Out Pulmonary Embolism During Pregnancy:a Multicenter Outcome Study
|
||
Completed |
NCT00816920 -
Natural History of Isolated Deep Vein Thrombosis of the Calf
|