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Pulmonary Embolism Response to Fragmentation, Embolectomy, & Catheter Thrombolysis: PERFECT

This study is currently recruiting participants.
Verified November 2012 by Stanford University
Sponsor:
Collaborators:
University of California, San Francisco
Maine Medical Center
University of Zaragoza
Adventist Midwest Health
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01097928
First received: March 30, 2010
Last updated: November 28, 2012
Last verified: November 2012
History of Changes

March 30, 2010
November 28, 2012
January 2009
January 2013   (final data collection date for primary outcome measure)
  • Resolution of hypoxia [ Time Frame: Post-procedure and 3 months ] [ Designated as safety issue: No ]
  • Survival from acute PE [ Time Frame: Post-procedure and 3 months ] [ Designated as safety issue: No ]
  • Stabilization of hemodynamics [ Time Frame: Post-procedure and 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01097928 on ClinicalTrials.gov Archive Site
Clinical practice patterns across centers [ Time Frame: 5yrs ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Pulmonary Embolism Response to Fragmentation, Embolectomy, & Catheter Thrombolysis: PERFECT
Pulmonary Embolism Response to Fragmentation, Embolectomy, & Catheter Thrombolysis: The PERFECT Registry

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
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Any adult patient who has developed a pulmonary embolism, and who will be undergoing catheter directed debulking of the embolus.
Pulmonary Embolism
Procedure: Catheter directed debulking of Pulmonary Embolus
A catheter will be used to break up the pulmonary embolism
Patients undergoing Pulmonary Embolectomy
Intervention: Procedure: Catheter directed debulking of Pulmonary Embolus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
January 2014
January 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: William Kuo (650) 724-7362 wkuo@stanford.edu
United States
 
NCT01097928
SU-03292010-5502, eProtocol ID 14793
Not Provided
Stanford University
Stanford University
  • University of California, San Francisco
  • Maine Medical Center
  • University of Zaragoza
  • Adventist Midwest Health
Principal Investigator: William T Kuo MD Stanford University
Stanford University
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP