An observational study in Pulmonary Embolism, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-08.
Sponsored by Stanford University · Observational
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)
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
753 studies on the registry are indexed under Pulmonary Embolism; 157 are open to participants now.
This study's enrollment of 333 is close to the median of 370 across 332 observational studies indexed under Pulmonary Embolism.
Browse Pulmonary Embolism studies →Stanford University is the lead sponsor of 2,161 studies on the registry; 428 are open to participants now.
Of its 268 completed or terminated interventional studies of FDA-regulated products, 207 (77%) have results posted.
Counted across the registry records on this site, refreshed daily.
Any adult patient who has developed a pulmonary embolism, and who will be undergoing catheter directed debulking of the embolus.
Inclusion Criteria:
Procedure: Catheter directed debulking of Pulmonary Embolus
A catheter will be used to break up the pulmonary embolism
Resolution of hypoxia
Time frame: Post-procedure and 3 months
Survival from acute PE
Time frame: Post-procedure and 3 months
Stabilization of hemodynamics
Time frame: Post-procedure and 3 months
Clinical practice patterns across centers
Time frame: 5yrs
Ran from Jan 2010 to primary completion in Jan 2020, 120 months.
Of 122 non-industry observational studies under Pulmonary Embolism, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 120. This study's 120 months is above that.
Counting every sponsor, half of 145 studies reached it within 48 months; a quarter within 23 and three quarters within 105.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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