Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date March 30, 2010
First Posted Date April 2, 2010
Last Update Posted Date July 12, 2019
Study Start Date January 2010
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 31, 2010)
  • 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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 31, 2010)
Clinical practice patterns across centers [ Time Frame: 5yrs ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Pulmonary Embolism Response to Fragmentation, Embolectomy, & Catheter Thrombolysis: PERFECT
Official Title Pulmonary Embolism Response to Fragmentation, Embolectomy, & Catheter Thrombolysis: The PERFECT Registry
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)
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 Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Pulmonary Embolism
Intervention Procedure: Catheter directed debulking of Pulmonary Embolus
A catheter will be used to break up the pulmonary embolism
Study Groups/Cohorts Patients undergoing Pulmonary Embolectomy
Intervention: Procedure: Catheter directed debulking of Pulmonary Embolus
Publications * Kuo WT, Banerjee A, Kim PS, DeMarco FJ Jr, Levy JR, Facchini FR, Unver K, Bertini MJ, Sista AK, Hall MJ, Rosenberg JK, De Gregorio MA. Pulmonary Embolism Response to Fragmentation, Embolectomy, and Catheter Thrombolysis (PERFECT): Initial Results From a Prospective Multicenter Registry. Chest. 2015 Sep;148(3):667-673. doi: 10.1378/chest.15-0119.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 31, 2010)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2020
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: William Kuo (650) 724-7362 wkuo@stanford.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01097928
Other Study ID Numbers SU-03292010-5502
eProtocol ID 14793
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party William Kuo, Stanford University
Study Sponsor Stanford University
Collaborators
  • Adventist Midwest Health
  • Weill Medical College of Cornell University
  • Memorial Hospital of South Bend
  • Northside Hospital, Inc.
  • Universidad de Zaragoza
Investigators
Principal Investigator: William T Kuo MD Stanford University
PRS Account Stanford University
Verification Date July 2019