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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Stanford University
Sponsor:
Collaborators:
Adventist Midwest Health
Weill Medical College of Cornell University
Maine Medical Center
Memorial Hospital of South Bend
Northside Hospital, Inc.
University of Zaragoza
Information provided by (Responsible Party):
William Kuo, Stanford University
ClinicalTrials.gov Identifier:
NCT01097928
First received: March 30, 2010
Last updated: January 18, 2014
Last verified: January 2014
  Purpose

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 Intervention
Pulmonary Embolism
Procedure: Catheter directed debulking of Pulmonary Embolus

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Pulmonary Embolism Response to Fragmentation, Embolectomy, & Catheter Thrombolysis: The PERFECT Registry

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Clinical practice patterns across centers [ Time Frame: 5yrs ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2010
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients undergoing Pulmonary Embolectomy Procedure: Catheter directed debulking of Pulmonary Embolus
A catheter will be used to break up the pulmonary embolism

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01097928

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

Locations
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.
University of Zaragoza
Investigators
Principal Investigator: William T Kuo MD Stanford University
  More Information

No publications provided

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
Study First Received: March 30, 2010
Last Updated: January 18, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 19, 2014