Pulmonary Embolism
Conditions
Brief summary
A prospective observational study to evaluate the safety and effectiveness data of catheter-directed therapy (CDT) including percutaneous mechanical thrombectomy (PMT) for treatment of acute pulmonary embolism (PE)
Detailed description
The primary objective of this study is to capture high quality patient safety and effectiveness data on CDT for acute PE. The goal will be achieved by capturing a concise set of immediate and short-term functional and clinical outcome data for PE patients undergoing CDT. Secondary study objectives include the following: \- To assess and benchmark clinical practice patterns (patient selection, optimal technique, use of procedure worldwide) These objectives will be achieved through the capture of selected process data for patients included in the registry. Data collected in this study may also be used to develop and refine standards of care for use of CDT for PE and to facilitate the design of randomized clinical trials
Interventions
PROCEDURECatheter directed debulking of Pulmonary Embolus
A catheter will be used to break up the pulmonary embolism
Sponsors
Adventist Midwest Health
Weill Medical College of Cornell University
Memorial Hospital of South Bend
Northside Hospital, Inc.
Universidad de Zaragoza
Stanford University
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must be Age greater than or equal to 18 * Obtain informed written consent. * Diagnosed with acute pulmonary embolism (PE) (\< 14 days) * Catheter-directed therapy (CDT) was performed to treat acute PE
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Resolution of hypoxia | Post-procedure and 3 months |
| Survival from acute PE | Post-procedure and 3 months |
| Stabilization of hemodynamics | Post-procedure and 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Clinical practice patterns across centers | 5yrs |
Countries
United States
Outcome results
None listed