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

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ClinicalTrials.gov Identifier: NCT01097928
Recruitment Status : Recruiting
First Posted : April 2, 2010
Last Update Posted : April 22, 2016
Information provided by (Responsible Party):

Study Description
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

Study Type : Observational
Estimated Enrollment : 100 participants
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

U.S. FDA Resources

Groups and Cohorts

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.

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

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

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

United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: William Kuo    650-724-7362    wkuo@stanford.edu   
Contact: Fizaa Ahmed    (650) 725-6409    Fizaa@stanford.edu   
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
Maine Medical Center
Memorial Hospital of South Bend
Northside Hospital, Inc.
Universidad de Zaragoza
Principal Investigator: William T Kuo MD Stanford University
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: William Kuo, Associate Professor - Interventional Radiology, Stanford University
ClinicalTrials.gov Identifier: NCT01097928     History of Changes
Other Study ID Numbers: SU-03292010-5502
eProtocol ID 14793
First Posted: April 2, 2010    Key Record Dates
Last Update Posted: April 22, 2016
Last Verified: April 2016

Additional relevant MeSH terms:
Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases