NCT01097928

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
333

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 2, 2010

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 13, 2020

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
Last Updated

September 8, 2023

Status Verified

September 1, 2023

Enrollment Period

10 years

First QC Date

March 30, 2010

Last Update Submit

September 6, 2023

Conditions

Pulmonary Embolism

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Clinical practice patterns across centers

    5yrs

Study Arms (1)

Patients undergoing Pulmonary Embolectomy

Procedure: Catheter directed debulking of Pulmonary Embolus

Interventions

Catheter directed debulking of Pulmonary EmbolusPROCEDURE

A catheter will be used to break up the pulmonary embolism

Patients undergoing Pulmonary Embolectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any adult patient who has developed a pulmonary embolism, and who will be undergoing catheter directed debulking of the embolus.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (1)

  • 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.

    PMID: 25856269DERIVED

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • William T Kuo MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor - Interventional Radiology

Study Record Dates

First Submitted

March 30, 2010

First Posted

April 2, 2010

Study Start

January 1, 2010

Primary Completion

January 13, 2020

Study Completion

January 31, 2020

Last Updated

September 8, 2023

Record last verified: 2023-09

Locations

US(1)