Pulmonary Embolism Response to Fragmentation, Embolectomy, & Catheter Thrombolysis: PERFECT
This study is currently recruiting participants.
(see Contacts and Locations)
Verified April 2016 by Stanford University
Sponsor:
Stanford University
Collaborators:
Adventist Midwest Health
Weill Medical College of Cornell University
Maine Medical Center
Memorial Hospital of South Bend
Northside Hospital, Inc.
Universidad de Zaragoza
Information provided by (Responsible Party):
William Kuo, Stanford University
ClinicalTrials.gov Identifier:
NCT01097928
First received: March 30, 2010
Last updated: April 20, 2016
Last verified: April 2016
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Purpose
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)
| Condition | Intervention |
|---|---|
|
Pulmonary Embolism |
Procedure: Catheter directed debulking of Pulmonary Embolus |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Pulmonary Embolism Response to Fragmentation, Embolectomy, & Catheter Thrombolysis: The PERFECT Registry |
Resource links provided by NLM:
Further study details as provided by Stanford University:
Primary Outcome Measures:
- Resolution of hypoxia [ Time Frame: Post-procedure and 3 months ] [ Designated as safety issue: No ]
- Survival from acute PE [ Time Frame: Post-procedure and 3 months ] [ Designated as safety issue: No ]
- Stabilization of hemodynamics [ Time Frame: Post-procedure and 3 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Clinical practice patterns across centers [ Time Frame: 5yrs ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | January 2020 |
| Estimated Primary Completion Date: | January 2020 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Patients undergoing Pulmonary Embolectomy |
Procedure: Catheter directed debulking of Pulmonary Embolus
A catheter will be used to break up the pulmonary embolism
|
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
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Any adult patient who has developed a pulmonary embolism, and who will be undergoing catheter directed debulking of the embolus.
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01097928
Please refer to this study by its ClinicalTrials.gov identifier: NCT01097928
Contacts
| Contact: William Kuo | (650) 724-7362 | wkuo@stanford.edu |
Locations
| United States, California | |
| Stanford University School of Medicine | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: William Kuo 650-724-7362 wkuo@stanford.edu | |
| Contact: Fizaa Ahmed (650) 725-6409 Fizaa@stanford.edu | |
| Principal Investigator: William T Kuo MD | |
| Sub-Investigator: Daniel Yung-Ho Sze | |
| Sub-Investigator: Nishita N. Kothary | |
| Sub-Investigator: David Hovsepian | |
| Sub-Investigator: Dr. John D Louie | |
| Sub-Investigator: Gloria Hwang | |
| Sub-Investigator: David Wang, MD | |
| Sub-Investigator: Lawrence V Hofmann, MD | |
Sponsors and Collaborators
Stanford University
Adventist Midwest Health
Weill Medical College of Cornell University
Maine Medical Center
Memorial Hospital of South Bend
Northside Hospital, Inc.
Universidad de Zaragoza
Investigators
| Principal Investigator: | William T Kuo MD | Stanford University |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | William Kuo, Associate Professor - Interventional Radiology, Stanford University |
| ClinicalTrials.gov Identifier: | NCT01097928 History of Changes |
| Other Study ID Numbers: | SU-03292010-5502 eProtocol ID 14793 |
| Study First Received: | March 30, 2010 |
| Last Updated: | April 20, 2016 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Embolism Pulmonary Embolism Embolism and Thrombosis Vascular Diseases |
Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on September 30, 2016