Pulmonary Embolism Response to Fragmentation, Embolectomy, & Catheter Thrombolysis: PERFECT
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01097928 |
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Recruitment Status :
Recruiting
First Posted : April 2, 2010
Last Update Posted : April 18, 2018
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| Condition or disease | Intervention/treatment |
|---|---|
| Pulmonary Embolism | Procedure: Catheter directed debulking of Pulmonary Embolus |
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
| Study Type : | Observational |
| Estimated Enrollment : | 100 participants |
| Observational Model: | Other |
| Time Perspective: | Prospective |
| Official Title: | Pulmonary Embolism Response to Fragmentation, Embolectomy, & Catheter Thrombolysis: The PERFECT Registry |
| Study Start Date : | January 2010 |
| Estimated Primary Completion Date : | January 2020 |
| Estimated Study Completion Date : | January 2020 |
| Group/Cohort | Intervention/treatment |
|---|---|
| Patients undergoing Pulmonary Embolectomy |
Procedure: Catheter directed debulking of Pulmonary Embolus
A catheter will be used to break up the pulmonary embolism |
- Resolution of hypoxia [ Time Frame: Post-procedure and 3 months ]
- Survival from acute PE [ Time Frame: Post-procedure and 3 months ]
- Stabilization of hemodynamics [ Time Frame: Post-procedure and 3 months ]
- Clinical practice patterns across centers [ Time Frame: 5yrs ]
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01097928
| Contact: William Kuo | (650) 724-7362 | wkuo@stanford.edu |
| 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 | |
| Principal Investigator: | William T Kuo MD | Stanford University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | William Kuo, Professor - Interventional Radiology, Stanford University |
| ClinicalTrials.gov Identifier: | NCT01097928 History of Changes |
| Other Study ID Numbers: |
SU-03292010-5502 eProtocol ID 14793 |
| First Posted: | April 2, 2010 Key Record Dates |
| Last Update Posted: | April 18, 2018 |
| Last Verified: | April 2018 |
Additional relevant MeSH terms:
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Embolism Pulmonary Embolism Embolism and Thrombosis Vascular Diseases |
Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases |