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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01097928
Recruitment Status : Recruiting
First Posted : April 2, 2010
Last Update Posted : July 12, 2019
Sponsor:
Collaborators:
Adventist Midwest Health
Weill Medical College of Cornell University
Memorial Hospital of South Bend
Northside Hospital, Inc.
Universidad de Zaragoza
Information provided by (Responsible Party):
William Kuo, Stanford University

Study Description
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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)

Condition or disease Intervention/treatment
Pulmonary Embolism Procedure: Catheter directed debulking of Pulmonary Embolus

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 Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Pulmonary Embolism Response to Fragmentation, Embolectomy, & Catheter Thrombolysis: The PERFECT Registry
Study Start Date : January 2010
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Patients undergoing Pulmonary Embolectomy Procedure: Catheter directed debulking of Pulmonary Embolus
A catheter will be used to break up the pulmonary embolism


Outcome Measures
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Primary Outcome Measures :
  1. Resolution of hypoxia [ Time Frame: Post-procedure and 3 months ]
  2. Survival from acute PE [ Time Frame: Post-procedure and 3 months ]
  3. Stabilization of hemodynamics [ Time Frame: Post-procedure and 3 months ]

Secondary Outcome Measures :
  1. Clinical practice patterns across centers [ Time Frame: 5yrs ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any adult patient who has developed a pulmonary embolism, and who will be undergoing catheter directed debulking of the embolus.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01097928


Contacts
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Contact: William Kuo (650) 724-7362 wkuo@stanford.edu

Locations
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United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: William Kuo    650-724-7362    wkuo@stanford.edu   
Contact: Eldridge Thomas    6507366109    eldridgethomas@stanfordhealthcare.org   
Principal Investigator: William T Kuo MD         
Sub-Investigator: Daniel Yung-Ho Sze         
Sub-Investigator: Nishita N. Kothary         
Sub-Investigator: David Hovsepian         
Sub-Investigator: Dr. John D Louie         
Sub-Investigator: Gloria Hwang         
Sub-Investigator: David Wang, MD         
Sub-Investigator: Lawrence V Hofmann, MD         
Sponsors and Collaborators
Stanford University
Adventist Midwest Health
Weill Medical College of Cornell University
Memorial Hospital of South Bend
Northside Hospital, Inc.
Universidad de Zaragoza
Investigators
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Principal Investigator: William T Kuo MD Stanford University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: William Kuo, Professor - Interventional Radiology, Stanford University
ClinicalTrials.gov Identifier: NCT01097928    
Other Study ID Numbers: SU-03292010-5502
eProtocol ID 14793
First Posted: April 2, 2010    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Pulmonary Embolism
Embolism
Embolism and Thrombosis
Vascular Diseases
 Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases