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Completed

NCT Number: NCT01097928

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

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)

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Key information

Conditions

Pulmonary Embolism Cardiovascular Diseases Embolism Embolism and Thrombosis Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Catheter directed debulking of Pulmonary Embolus

Procedure

A catheter will be used to break up the pulmonary embolism

Primary outcomes

  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 outcomes

  1. Clinical practice patterns across centers

    Time frame: 5yrs

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2020
Study completion
2020
First posted
Apr 2, 2010
Registry last updated
Sep 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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