- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01097928
Pulmonary Embolism Response to Fragmentation, Embolectomy, & Catheter Thrombolysis: PERFECT
Pulmonary Embolism Response to Fragmentation, Embolectomy, & Catheter Thrombolysis: The PERFECT Registry
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: William Kuo
- Phone Number: (650) 724-7362
- Email: wkuo@stanford.edu
Study Locations
-
-
California
-
Stanford, California, United States, 94305
- Stanford University School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients undergoing Pulmonary Embolectomy
|
A catheter will be used to break up the pulmonary embolism
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Resolution of hypoxia
Time Frame: Post-procedure and 3 months
|
Post-procedure and 3 months
|
Survival from acute PE
Time Frame: Post-procedure and 3 months
|
Post-procedure and 3 months
|
Stabilization of hemodynamics
Time Frame: Post-procedure and 3 months
|
Post-procedure and 3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Clinical practice patterns across centers
Time Frame: 5yrs
|
5yrs
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: William T Kuo MD, Stanford University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SU-03292010-5502
- eProtocol ID 14793
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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