Pulmonary Embolism Clinical Trial
— SPEEKOfficial title:
Submassive Pulmonary Embolism Experience With EKOS
This single site study evaluates the efficacy of ultrasound accelerated thrombolysis using EKOS Endovascular Device with a standard infusion of thrombolytics for treatment of PE
Status | Recruiting |
Enrollment | 50 |
Est. completion date | February 2017 |
Est. primary completion date | February 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Acute symptomatic PE confirmed by CT, with filling defect in at least one main or segmental pulmonary artery. 2. RV dysfunction as evidenced by RV/LV ratio > 0.9 on echo 3. Ability to give informed consent or Legally Authorized Representative (LAR) is able to give consent 4. PE symptom duration < 21 days 5. Age >18 years 6. And, a MBS baseline measurement above 3 plus at least one of the following: O2 sat < 90% RA, or inability to maintain a HR <100, or inability to maintain a Systolic Bp > 100. Whichever measurement is chosen for inclusion criteria in addition to the MBS will also be used in determination of therapeutic endpoint (i.e. O2 Sat., HR<100 or BP >100).. Exclusion Criteria: 1. Stroke or transient ischemic attack (TIA), head trauma, or other active intracranial or intraspinal disease within one year 2. Recent (within one month) or active bleeding from a major organ 3. Hemoglobin (Hgb) < 8.0 4. Platelets < 60 thousand/µL 5. Major surgery within seven days 6. Clinician deems high-risk for catastrophic bleeding 7. History of heparin-induced thrombocytopenia (HIT) 8. Pregnancy 9. Catheter-based pharmacomechanical treatment for pulmonary embolism within 3 days of study enrollment 10. Systolic blood pressure less than 80 mm Hg despite vasopressor or inotropic support 11. Cardiac arrest (including pulseless electrical activity and asystole) requiring active cardiopulmonary resuscitation (CPR) 12. Evidence of irreversible neurological compromise 13. Life expectancy < 30 days 14. Use of thrombolytics or glycoprotein IIb/IIIa antagonists within 3 days prior to inclusion in the study |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Fairfield Medical Center | Lancaster | Ohio |
Lead Sponsor | Collaborator |
---|---|
Krishna Mannava, MD, FACS, RPVI | EKOS Corporation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction of RV dysfunction | Reduction of RV dysfunction as evidenced by a reduction in RVSP and or a reduction in RV/LV ratio measured by echo at baseline and again at 48 ±6 hours post EKOS catheter removal | 48 hours post catheter removal | No |
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 |
NCT02334007 -
Extended Low-Molecular Weight Heparin VTE Prophylaxis in Thoracic Surgery
|
Phase 1/Phase 2 | |
Completed |
NCT02611115 -
Optimizing Protocols for the Individual Patient in CT Pulmonary Angiography.
|
N/A | |
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 |
NCT00780767 -
Angiojet Rheolytic Thrombectomy in Case of Massive Pulmonary Embolism
|
Phase 2 | |
Completed |
NCT00720915 -
D-dimer to Select Patients With First Unprovoked Venous Thromboembolism Who Can Have Anticoagulants Stopped at 3 Months
|
N/A | |
Completed |
NCT00771303 -
Ruling Out Pulmonary Embolism During Pregnancy:a Multicenter Outcome Study
|
||
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 |
NCT00816920 -
Natural History of Isolated Deep Vein Thrombosis of the Calf
|