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

NCT ID: NCT01097928

Last Updated: 2023-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

333 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2020-01-31

Brief Summary

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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

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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

Conditions

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Pulmonary Embolism

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients undergoing Pulmonary Embolectomy

Catheter directed debulking of Pulmonary Embolus

Intervention Type PROCEDURE

A catheter will be used to break up the pulmonary embolism

Interventions

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Catheter directed debulking of Pulmonary Embolus

A catheter will be used to break up the pulmonary embolism

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Adventist Midwest Health

UNKNOWN

Sponsor Role collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role collaborator

Memorial Hospital of South Bend

OTHER

Sponsor Role collaborator

Northside Hospital, Inc.

OTHER

Sponsor Role collaborator

Universidad de Zaragoza

OTHER

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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William Kuo

Professor - Interventional Radiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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William T Kuo MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status

Countries

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United States

References

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Kuo WT, Banerjee A, Kim PS, DeMarco FJ Jr, Levy JR, Facchini FR, Unver K, Bertini MJ, Sista AK, Hall MJ, Rosenberg JK, De Gregorio MA. Pulmonary Embolism Response to Fragmentation, Embolectomy, and Catheter Thrombolysis (PERFECT): Initial Results From a Prospective Multicenter Registry. Chest. 2015 Sep;148(3):667-673. doi: 10.1378/chest.15-0119.

Reference Type DERIVED
PMID: 25856269 (View on PubMed)

Other Identifiers

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eProtocol ID 14793

Identifier Type: -

Identifier Source: secondary_id

SU-03292010-5502

Identifier Type: -

Identifier Source: org_study_id

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