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

Pulmonary Embolism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01097928
• Other study ID #: SU-03292010-5502
• Secondary ID: eProtocol ID 147
• Status: Completed
• Start date: January 2010
• Est. completion date: January 31, 2020

Study information

• Verified date: September 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 333
• Est. completion date: January 31, 2020
• Est. primary completion date: January 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Intervention

Procedure:
• Catheter directed debulking of Pulmonary Embolus
A catheter will be used to break up the pulmonary embolism

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (6)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resolution of hypoxia		Post-procedure and 3 months
Primary	Survival from acute PE		Post-procedure and 3 months
Primary	Stabilization of hemodynamics		Post-procedure and 3 months
Secondary	Clinical practice patterns across centers		5yrs