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

September 6, 2023 updated by: William Kuo, Stanford University

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

333

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Resolution of hypoxia
Time Frame: Post-procedure and 3 months
Post-procedure and 3 months
Survival from acute PE
Time Frame: Post-procedure and 3 months
Post-procedure and 3 months
Stabilization of hemodynamics
Time Frame: Post-procedure and 3 months
Post-procedure and 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical practice patterns across centers
Time Frame: 5yrs
5yrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

Weill Medical College of Cornell University
Northside Hospital, Inc.
Universidad de Zaragoza
Memorial Hospital of South Bend
Adventist Midwest Health

Investigators

  • Principal Investigator: William T Kuo MD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2010

Primary Completion (Actual)

January 13, 2020

Study Completion (Actual)

January 31, 2020

Study Registration Dates

First Submitted

March 30, 2010

First Submitted That Met QC Criteria

March 31, 2010

First Posted (Estimated)

April 2, 2010

Study Record Updates

Last Update Posted (Actual)

September 8, 2023

Last Update Submitted That Met QC Criteria

September 6, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SU-03292010-5502
  • eProtocol ID 14793

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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