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

Completed

• Conditions: Pulmonary Embolism
• Interventions: Procedure: Catheter directed debulking of Pulmonary Embolus

• Registration Number: NCT01097928
• Lead Sponsor: Stanford University

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-03-30
• Study First Submitted QC: 2010-03-31
• Study First Posted: 2010-04-02
• Primary Completion: 2020-01-13
• Study Completion: 2020-01-31
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-06
• Last Update Posted: 2023-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 333

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients undergoing Pulmonary Embolectomy	Catheter directed debulking of Pulmonary Embolus	-

Primary Outcome Measures

Name	Time	Method
Resolution of hypoxia	Post-procedure and 3 months
Survival from acute PE	Post-procedure and 3 months
Stabilization of hemodynamics	Post-procedure and 3 months

Secondary Outcome Measures

Name	Time	Method
Clinical practice patterns across centers	5yrs

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States